OBJECTIVES

In this randomized trial, we compared the effectiveness of 2 diets (enhanced stop light diet [eSLD] versus conventional meal plan diet [CD]) and 2 delivery strategies (face–to–face [FTF] versus remote delivery [RD]) on weight loss across 6 months in adolescents with intellectual and developmental disabilities who were overweight or obese.

METHODS

Participants were randomly assigned to 1 of 3 arms (FTF/CD, RD/CD, or RD/eSLD) and asked to attend one-on-one sessions with a health educator every 2 weeks to aid in maintaining compliance with recommendations for a reduced-energy diet and increased physical activity. The CD followed the US dietary guidelines. The eSLD used the stop light guide and was enhanced with portion-controlled meals. The FTF arm was delivered during in-person home visits. The RD arms were delivered by using video conferencing.

RESULTS

A total of 110 adolescents with intellectual and developmental disabilities (aged ∼16 years, 53% female, BMI 33) were randomly assigned to the FTF/CD (n = 36), RD/CD (n = 39), or RD/eSLD (n = 35) group. Body weight at 6 months was obtained from 97%, 100%, and 86% of participants in the FTF/CD, RD/CD, and RD/eSLD arms, respectively. The eSLD elicited significantly greater weight loss than the CD: RD/eSLD (−5.0 ± 5.9 kg; −6.4%) versus RD/CD (−1.8 ± 4.0 kg; −2.4%) (P = .01). However, weight loss did not differ by delivery strategy: FTF/CD (−0.3 ± 5.0 kg; −0.2%) versus RD/CD (−1.8 ± 4.0 kg; −2.4%) (P = .20).

CONCLUSIONS

The eSLD elicited significantly greater 6-month weight loss compared with a CD when both interventions were delivered remotely. Minimal 6-month weight loss, which did not differ significantly between FTF delivery and RD, was observed with a CD.

What’s Known on This Subject:

The prevalence of overweight and obesity is higher in adolescents with intellectual and developmental disabilities compared with their typically developing peers. However, evidence-based strategies for weight management specific to adolescents with developmental disabilities are currently unavailable.

What This Study Adds:

In this study, we compared 2 diets and 2 delivery systems for weight loss in adolescents with intellectual and developmental disabilities. Results revealed that the enhanced stop light diet, delivered remotely, is a viable strategy to achieve weight loss.

Approximately 1% to 3% of the US population is diagnosed with an intellectual or developmental disability (IDD), defined as a disability originating before the age of 10 and characterized by significant limitations in both intellectual functioning (IQ < 75) and ≥2 adaptive behaviors.1  The prevalence of obesity (BMI in the ≥95th percentile) is higher in adolescents with IDDs (22%–60%)24  compared with typically developing peers (20.6%).5  However, evidence-based strategies for weight management specific to adolescents with IDDs are currently unavailable.

A limited number of short-term (≤20 weeks) small-sample (n ≤ 20) trials (n = 11 trials, n = 2 randomized trials) have evaluated the impact of lifestyle interventions on body weight in youth with IDDs and have revealed minimal 6-month weight loss, that is, <3 kg.2,6  The majority of these trials included increased physical activity without an energy-reduced diet and thus do not comply with current guidelines for the management of overweight and obesity.7  The limited available evidence and the generally small magnitude of reported weight loss suggests that additional innovative strategies for weight management for adolescents with IDD need to be developed and evaluated.

Previous work by our group has suggested the potential of the enhanced stop light diet (eSLD), when delivered remotely and when using technology for self-monitoring diet and physical activity, to elicit clinically relevant weight loss in adolescents with IDD. The stop light diet, originally developed by Epstein and Squires8  for use in children, categorizes foods by energy content: green (low energy, consume freely), yellow (moderate energy, consume in moderation), and red (high energy, consume sparingly). In addition to using the stop light system for making appropriate food choices, the eSLD encourages the consumption of high-volume, low-energy, portion-controlled entrées and shakes and fruits and vegetables. The eSLD is easy to understand, simplifies meal planning and food shopping and meal preparation, and does not require the ability to read and comprehend educational materials, nutrition labels, etc, which is required in weight management programs designed for typically developed individuals. Remote delivery (RD) offers potential benefits for the delivery of weight management programs to adolescents with IDD. The group-based on-site face-to-face (FTF) format that is traditionally used for the delivery of weight management programs in typically developing individuals may be problematic for individuals with IDD, who frequently have difficulty maintaining focus in a group setting and require individualized instruction and support that is impractical in a group format. The costs and time associated with travel to attend on-site programs may also present as barriers to participation for adolescents with IDD, who are dependent on parents or care providers for transportation. Additionally, in many areas (eg, rural or inner city), access to on-site programs is limited.

We completed a 2-month pilot trial in adolescents with IDD who were overweight or obese to compare the effectiveness of the eSLD and conventional meal plan diet (CD) and to determine the feasibility of intervention delivery using individual meetings with the adolescent and a parent conducted via video chat (FaceTime) on a tablet computer (iPad) and using technology for remote self-monitoring of diet (Lose It!) and physical activity (Fitbit).9  Twenty participants (45% female, aged ∼15 years) were randomly assigned (eSLD, n = 10; CD, n = 10) and completed the intervention. Participants and parents met weekly (∼30 minutes) with a registered dietitian nutritionist to receive nutrition education and feedback relative to their self-monitoring data on diet and physical activity. Although not statistically significant, weight loss was greater in the eSLD group (−4.9%) compared with the CD group (−3.3%; P = .13). Participants were able to use the tablet computer to track their dietary intake and physical activity on ∼83% and 60% of possible study days, respectively. Adolescents and parents attended 80% of the scheduled weekly video chat meetings. On the basis of the encouraging results from our 2-month pilot trial, we conducted a adequately powered randomized trial to evaluate 2 important components of a weight management intervention that have not previously been evaluated in adolescents with IDD who are overweight or obese: strategies for reducing energy intake (eSLD versus CD) and intervention delivery (RD versus FTF). Intervention arms included FTF delivery with a CD (FTF/CD), RD with a CD (RD/CD), and RD with an eSLD (RD/eSLD). Results for our primary aim, a comparison of diets (RD/CD versus RD/eSLD) and delivery strategies (FTF/CD versus RD/CD) for weight loss across 6 months, are presented herein.

A detailed description of the rationale, design, and methods for this trial has been published previously.10  We randomly assigned 110 adolescents with mild to moderate IDD who were overweight and obese to 1 of 3 intervention arms for a 6-month weight loss trial, followed by 12 months of weight maintenance, to compare strategies for reducing energy intake and intervention delivery. This trial, which was approved by the university’s institutional review board and registered on ClinicalTrials.gov (identifier NCT02561754), was conducted in the local metropolitan area from November 2015 to May 2020.

Participants satisfying the following inclusion criteria were eligible for this trial: age 13 to 21 years; mild to moderate IDD (IQ 40–74), as verified by a primary care physician; BMI ≥ the 85th percentile on Centers for Disease Control and Prevention growth charts (≤19 years of age) or BMI ≥25 (<19 years of age) or waist circumference/height ratio >0.5, which indicates excess central adiposity in children and adolescents1114  and is commonly observed in youth with Down syndrome15 ; sufficient functional ability to understand directions and communicate through spoken language; living at home with a parent or guardian; and Internet access in the home. Exclusion criteria included the following: type 1 diabetes or type 2 diabetes treated with insulin, Prader-Willi syndrome, participation in a weight management program involving diet and physical activity in the past 6 months, eating disorders, serious food allergies, consuming special diets, and the inability to participate in moderate to vigorous physical activity. To enhance the generalizability of our findings, individuals who used medications for prevalent conditions associated with obesity or other medications commonly prescribed for individuals with IDD were allowed to participate. Clearance from a primary care physician was required for all participants.

Participants were recruited through local community programs serving adolescents with IDD and by using print and Web advertisements in the target area. Participants were randomly assigned to intervention arms after providing signed informed parental consent and/or adolescent assent and written physician clearance. Randomization was stratified by BMI (25.0–29.9 vs ≥30) for participants aged >19 and BMI percentile (<95th percentile versus ≥95th percentile) for participants aged 19 and younger.

Health educators conducted 2 home visits with each adolescent and a parent before initiating the intervention. These sessions included detailed descriptions of the dietary and physical activity components of the intervention and the respective delivery and self-monitoring formats. Participants were oriented to the use of the iPad (Apple Inc, Cupertino, CA) provided by the trial. The iPads for the RD arms were preloaded with the Lose It! (FitNow, Inc, Boston MA), Fitbit (Google LLC, Mountain View, CA), and wireless scale applications (Withings Inc, Cambridge, MA), which were used for self-monitoring diet, physical activity, and body weight, respectively. Participants in the RD arms were oriented to the use of these applications and FaceTime, which was used for intervention delivery. Participants in the FTF arm were provided pedometers to self-monitor physical activity (Omron HJ-320; Omron Healthcare, Inc, Lake Forest, IL) and were shown how to self-monitor diet and body weight using paper records designed specifically for individuals with IDD.

Adolescents were required to designate 1 parent to serve as the primary family contact. Parents were asked to attend all behavioral sessions to familiarize themselves with both the diet and physical activity recommendations and the behavioral strategies incorporated in the intervention. Parents were asked to provide support and encouragement as well as to assist with meal planning, grocery shopping, preparing meals following the diet recommendations, performing physical activity, and self-monitoring participants’ diet, physical activity, and body weight.

Diet

Energy intake for weight loss was prescribed at 500 to 700 kcal/day below the total daily energy expenditure estimated by using the Dietary Reference Intake total energy intake equation for boys and girls with overweight.16 

The stop light diet was enhanced by encouraging the consumption of high-volume, low-energy, portion-controlled entrées and shakes (HRM Weight Management Services Corp, Boston, MA) and fruits and vegetables. Participants were encouraged to consume a minimum of 2 entrées (200–270 kcal each), 2 shakes (∼100 kcal each), 5 one-cup servings of fruits and vegetables each day, and lower-energy foods (green and yellow) from a chart of foods that were color coded on the basis of the stop light diet system. The recommended entrées and shakes, which were provided by the trial, were shipped to the participants’ homes every other week. The entrées and shakes provided ∼700 kcals/day or ∼50% of a participant’s recommended energy intake (based on a 1400-kcal/day diet).

Participants randomly assigned to the CD arms were asked to follow a nutritionally balanced, reduced-energy diet that followed the recommendations found on the US Department of Agriculture Web site ChooseMyPlate.gov17  and the Dietary Guidelines for Americans.18  Participants were provided with examples of meal plans consisting of suggested servings of grains, proteins, fruits and vegetables, dairy, and fats based on their energy needs and were counseled on appropriate portion sizes required to achieve the prescribed level of energy reduction. The consumption of a minimum of 5 one-cup servings of fruits and vegetables per day was also encouraged. To assist in offsetting any additional costs associated with complying with dietary recommendations, participants in the CD arms received $2.00 per day.

Physical Activity

Participants in each intervention arm were asked to reach a target of 60 minutes per day of moderate- to vigorous-intensity physical activity (3–6 metabolic equivalent of task) at least 5 days per week (total 300 minutes per week), as recommended by the US Department of Health and Human Services.19  The recommendation progressed from 15 minutes per day 3 days per week at week 1 (or current activity level if higher) to 60 min per day 5 days per week at week 12 and remained at that level through 6 months. Participants were also asked to increase their daily steps by 10% each week from their current level until reaching a goal of 10 000 steps per day.

Behavioral Education Sessions

Participants and parents in all intervention arms were asked to attend ∼30- to 45-minute sessions with a health educator twice each month. Behavioral session content and duration were identical in all 3 intervention arms and included strategies to improve weight loss (eg, social support, self-monitoring, planning, environmental control, self-efficacy, etc). In addition to the lesson, health educators reviewed self-monitoring data for diet, physical activity, and weight; answered questions; problem-solved; and provided support. Because of coronavirus disease 2019 (COVID-19) restrictions on FTF contacts, 1 participant completed 2 behavioral sessions and 1 participant completed 1 behavioral session by telephone. The duration and content of the telephone sessions were identical to that of the originally scheduled FTF sessions.

Self-Monitoring

In the RD arms, participants were asked to record all food and beverages consumed using the Lose It! application on the iPad. These data were accessible to health educators to inform participant counseling during behavioral sessions. Self-monitoring of physical activity was completed by using a Fitbit Charge HR wireless activity tracker (size 35.5 × 28 mm) worn on the wrist, and data were available to health educators for use in participant counseling. To provide feedback regarding weight change, participants in the RD arms self-weighed during the FaceTime health education session using a calibrated wireless digital scale (Model WS-30; Withings Inc).

In the FTF arm, participants were asked to record the number of servings of each food group consumed using a paper form containing pictorial representations of each food category as well as the minutes of physical activity and the number of pedometer steps each day. These records were collected by health educators and were used to provide participant feedback and counseling. Body weight was monitored by using a calibrated digital scale (Model #PS6600; Belfour, Saukville, WI) during each behavioral session. FTF participants who completed behavioral sessions by telephone (ie, COVID-19 protocol) verbally provided self-monitoring data to the health educator; however, body weight, typically obtained during FTF sessions, was unavailable for sessions conducted by telephone.

Health educators were randomly assigned to participants in each of the 3 intervention arms to diminish the potential for health educator bias. All health educator–participant sessions were recorded, and intervention fidelity was assessed by comparing recordings with a checklist of content to be delivered. On average, behavioral education sessions delivered 96% of the scheduled content. Eighty percent or more of scheduled content was delivered in all behavioral sessions.

All participants were allowed to keep their iPads. As an additional incentive, participants received $2 for each week they completed self-monitoring for diet and physical activity on at least 5 of 7 days per week. All participants and parents received gift cards ($15 for participants, $10 for parents) for completing outcome assessments at baseline and 6 months.

Weight, height, and waist circumference were assessed during home visits at baseline and 6 months by trained staff blinded to condition. Weight was measured in duplicate to the nearest 0.1 kg by using a calibrated digital scale (Model #PS6600; Belfour), with participants wearing shorts and a t-shirt. Standing height was measured in duplicate with a portable stadiometer (Model #IP0955; Invicta Plastics Limited, Leicester, United Kingdom). Waist circumference was measured by using the procedures described by Lohman et al.20  Three measurements were obtained, with the outcome recorded as the average of the closest 2 measures. The percentage of behavioral sessions attended was calculated from attendance data collected by the health educator. The percentage of days for which participants provided data for self-monitoring of diet and physical activity was collected from health educator records.

We realize there is controversy regarding the most informative measure for assessing change in adiposity in longitudinal trials in adolescents with increasing height over time, for example, weight, BMI, BMIz score, or the percentage of participants at or above the 95th percentile.2123  Our study population ranged in age from 13 to 21 years and thus included 15 participants aged >19 (17%), for whom the BMI percentile and associated outcomes (ie, calculations for BMI z score and percentage at or above the 95th percentile) were unavailable. Thus, we selected change in body weight (kilograms) as our primary outcome. Secondarily, we evaluated changes in BMI between intervention arms, which accounts for any increases in height over the intervention period.22 

On the basis of the data from our preliminary trial, we expected significantly greater weight loss for the RD/CD (−4.0 kg) compared with the FTF/CD (−1.5 kg) arm and significantly greater weight loss for the RD/eSLD (−6.5 kg) compared with the RD/CD (−4.0 kg) arm at 6 months, with a common SD of 3.6 kg.9  With these weight loss assumptions, 35 participants in each of the 3 intervention arms at 6 months would provide >99% power for an overall analysis of variance comparing the 3 groups for a global difference. However, we were interested in 2 pairwise comparisons (RD/CD versus FTF/CD, RD/eSLD versus RD/CD) and chose our sample size to ensure sufficient power for those comparisons. Thus, this design resulted in 80% power to detect the hypothesized differences, with a type 1 error rate of 0.025 for each of the 2 pairwise comparisons of interest from the overall analysis of variance. This Bonferroni adjustment is a conservative adjustment to the type 1 error rate to ensure our overall type 1 error rate is ≤5%.

Sample characteristics and outcomes were summarized by using means and SDs for continuous variables and frequencies and percentages for categorical variables. Separate 2-sample t tests were used to compare weight loss (0–6 months) between the RD/CD and RD/eSLD (diet effect) arms and the RD/CD and FTF/CD (delivery strategy effect) arms. Analysis of the primary outcome, weight change (kilograms) from baseline to 6 months, was based on intent-to-treat principles with multiple imputation, followed by a completer’s-only analysis. SAS Proc MI (SAS Institute, Inc, Cary, NC) was used to create 5 imputed data sets for weight change across 6 months by modeling missing data as a function of baseline weight, intervention arm, and age. All other analyses were performed on completers only per the study design. Between-arm differences in percentage weight change, changes in BMI, percentage change in BMI, and waist circumference were evaluated by using 2-sample t tests. Separate linear regressions were used to evaluate the independent effects of age, sex, race, behavioral session attendance, self-monitoring, and Down syndrome diagnosis on weight change after controlling for intervention arm. All analyses were conducted by using SAS 9.4 (SAS Institute, Inc).

Adolescents with IDD (n = 110) were randomly assigned to the FTF/CD (n = 36), RD/CD (n = 39), or RD/eSLD (n = 35) arm. Body weight was obtained from 35 (97%), 39 (100%), and 30 (86%) participants after weight loss for the FTF/CD, RD/CD, and RD/eSLD groups, respectively (Fig 1). Because of COVID-19 restrictions, we were unable to obtain 6-month data for waist circumference and height on 5 participants. Baseline participant characteristics are presented in Table 1. Participants were ∼16 years of age, ∼53% female, and ∼81% non-Hispanic white. Additionally, ∼48% were diagnosed with Down syndrome and ∼28% were diagnosed with autism spectrum disorder. No serious adverse events occurred during the intervention.

FIGURE 1

Consort diagram.

FIGURE 1

Consort diagram.

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TABLE 1

Baseline Characteristics of Adolescents With IDDs by Intervention Arm

FTF/CD (n = 36)RD/CD (n = 39)RD/eSLD (n = 35)
Age, mean (SD), y 16.3 (2.7) 15.6 (1.7) 16.7 (2.5) 
Sex, % (n   
 Male 56 (20) 39 (15) 49 (17) 
 Female 44 (16) 62 (24) 51 (18) 
Race, % (n   
 White 83 (30) 97 (38) 83 (29) 
 Black 8 (3) 0 (0) 11 (4) 
 ≥2 or more races 8 (3) 3 (1) 6 (2) 
Ethnicity, % (n   
 Not Hispanic 94 (34) 95 (37) 89 (31) 
 Hispanic 6 (2) 5 (2) 11 (4) 
Diagnosis, % (n   
 Autism spectrum disorder 42 (15) 36 (14) 37 (13) 
 Down syndrome 47 (17) 54 (21) 43 (15) 
 Other 11 (4) 10 (4) 20 (7) 
Wt, mean (SD), kg 88.4 (29.5) 74.9 (16.5) 83.6 (26.4) 
BMI, mean (SD) 34.1 (8.3) 31.3 (5.8) 32.7 (7.1) 
BMI percentile, mean (SD)a 96th (6th) 95th (6th) 96th (4th) 
BMI classification, n (%)    
 Healthy wt with a waist circumference to height ratio >0.5b 1 (3) 3 (8) 1 (3) 
 Overweightc 9 (25) 9 (23) 9 (26) 
 Obesed 26 (72) 27 (69) 25 (71) 
Waist circumference, mean (SD), cm 98.3 (17.1) 90.5 (11.3) 94.4 (15.3) 
FTF/CD (n = 36)RD/CD (n = 39)RD/eSLD (n = 35)
Age, mean (SD), y 16.3 (2.7) 15.6 (1.7) 16.7 (2.5) 
Sex, % (n   
 Male 56 (20) 39 (15) 49 (17) 
 Female 44 (16) 62 (24) 51 (18) 
Race, % (n   
 White 83 (30) 97 (38) 83 (29) 
 Black 8 (3) 0 (0) 11 (4) 
 ≥2 or more races 8 (3) 3 (1) 6 (2) 
Ethnicity, % (n   
 Not Hispanic 94 (34) 95 (37) 89 (31) 
 Hispanic 6 (2) 5 (2) 11 (4) 
Diagnosis, % (n   
 Autism spectrum disorder 42 (15) 36 (14) 37 (13) 
 Down syndrome 47 (17) 54 (21) 43 (15) 
 Other 11 (4) 10 (4) 20 (7) 
Wt, mean (SD), kg 88.4 (29.5) 74.9 (16.5) 83.6 (26.4) 
BMI, mean (SD) 34.1 (8.3) 31.3 (5.8) 32.7 (7.1) 
BMI percentile, mean (SD)a 96th (6th) 95th (6th) 96th (4th) 
BMI classification, n (%)    
 Healthy wt with a waist circumference to height ratio >0.5b 1 (3) 3 (8) 1 (3) 
 Overweightc 9 (25) 9 (23) 9 (26) 
 Obesed 26 (72) 27 (69) 25 (71) 
Waist circumference, mean (SD), cm 98.3 (17.1) 90.5 (11.3) 94.4 (15.3) 
a

Calculated for participants aged ≤19 y (FTF and CD = 30, RD and CD = 38, RD and eSLD = 27).

b

BMI percentile <85th percentile (age ≤19 y) or BMI <25 (age >19 y).

c

BMI percentile 85th–94th percentile (age ≤19 y) or BMI 25–29.9 (age >19 y).

d

BMI percentile ≥95th percentile (age ≤19 y) or BMI ≥30 (age >19 y).

Weight loss at 6 months was significantly greater in the RD/eSLD (−5.0 ± 5.9 kg; −6.4%) compared with the RD/CD arm (−1.8 ± 4.0 kg, −2.4%) (P = .01 [imputation], P = .02 [completers only]) (Table 2, Fig 2). Similar to the results for body weight, reductions in BMI were significantly greater in the RD/eSLD (−2.2 ± 2.5; 6.9%) compared with the RD/CD arm (−0.9 ± 1.6; 3.0%) (P = .02) (Table 2, Fig 3). However, there were no significant differences for change in waist circumference (P = .23) between the RD/eSLD and RD/CD arms. The proportion of participants with ≥5% weight loss was higher in the RD/eSLD (53%) than in the RD/CD arm (28%), and the proportion of participants with ≥3% of weight gain was higher in the RD/CD (10%) than in the RD/eSLD arm (3%) (Table 3, Fig 2). There were no significant differences between the RD/CD and RD/eSLD arms for the percentage of behavioral sessions attended, as assessed from health educator records (RD/CD = 83%, RD/eSLD = 79%; P = .56), or for the percentage of days of self-monitoring of diet (RD/CD = 76%, RD/eSLD = 76%; P = .93) and physical activity (RD/CD = 71%, RD/eSLD = 73%; P = .69), assessed as the percentage of days participants recorded data for diet and physical activity.

FIGURE 2

Individual variations of percentage change in weight in adolescents with IDD across 6 months.

FIGURE 2

Individual variations of percentage change in weight in adolescents with IDD across 6 months.

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FIGURE 3

Individual variations of percentage change in BMI in adolescents with IDDs across 6 months.

FIGURE 3

Individual variations of percentage change in BMI in adolescents with IDDs across 6 months.

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TABLE 2

Change in Weight, BMI, and Waist Circumference Across 6 Months in Adolescents With IDD

nFTF/CD, Mean (SD)nRD/CD, Mean (SD)nRD/eSLD, Mean (SD)Delivery, PDiet, P
Wt Δ, kg 35 −0.3 (5.0) 39 −1.8 (4.0) 30 −5.0 (5.9) .16 .02 
Wt Δ, % 35 −0.2 (5.4) 39 −2.4 (5.1) 30 −6.4 (7.9) .07 .02 
BMI Δ 34 −0.4 (1.6) 36 −0.9 (1.6) 29 −2.2 (2.5) .24 .02 
BMI Δ, % 34 −1.0 (4.9) 35 −3.0 (5.1) 29 −6.9 (8.1) .10 .02 
Waist circumference Δ, cm 34 −1.1 (4.2) 31 −2.4 (4.4) 27 −4.2 (6.1) .23 .23 
nFTF/CD, Mean (SD)nRD/CD, Mean (SD)nRD/eSLD, Mean (SD)Delivery, PDiet, P
Wt Δ, kg 35 −0.3 (5.0) 39 −1.8 (4.0) 30 −5.0 (5.9) .16 .02 
Wt Δ, % 35 −0.2 (5.4) 39 −2.4 (5.1) 30 −6.4 (7.9) .07 .02 
BMI Δ 34 −0.4 (1.6) 36 −0.9 (1.6) 29 −2.2 (2.5) .24 .02 
BMI Δ, % 34 −1.0 (4.9) 35 −3.0 (5.1) 29 −6.9 (8.1) .10 .02 
Waist circumference Δ, cm 34 −1.1 (4.2) 31 −2.4 (4.4) 27 −4.2 (6.1) .23 .23 

P values are based on analysis of completers only (ie, participants with data at baseline and 6 mo).

TABLE 3

Distribution of Weight Change in Adolescents With IDD Across 6 Months

FTF/CDRD/CDRD/eSLD
n%n%n%
Wt loss, %       
 0–<3 11 31 13 33 
 3–<5 11 13 17 
 5–<10 18 23 
 ≥10 10 30 
Wt gain, %       
 0–<3 26 15 20 
 ≥3 20 10 
FTF/CDRD/CDRD/eSLD
n%n%n%
Wt loss, %       
 0–<3 11 31 13 33 
 3–<5 11 13 17 
 5–<10 18 23 
 ≥10 10 30 
Wt gain, %       
 0–<3 26 15 20 
 ≥3 20 10 

Weight loss at 6 months did not differ significantly between the FTF/CD (−0.3 ± 5.0 kg; −0.2%) and RD/CD arms (−1.8 ± 4.0 kg; −2.4%) (P = .20 [imputation], P = .16 [completers only]) (Table 2, Fig 2). There were no significant differences between the FTF/CD and RD/CD arms for change in BMI (P = .24), percentage change in BMI (P = .10), or waist circumference (P = .23) (Table 2, Fig 3). The proportion of participants with ≥5% weight loss was higher in the RD/CD (28%) than in the FTF/CD arm (12%), whereas the proportion of participants who had ≥3% weight gain was higher in the FTF/CD (20%) than in the RD/CD arm (10%) (Table 3, Fig 2). There were no significant differences between the FTF/CD and RD/CD arms for the percentage of behavioral sessions attended (FTF/CD = 86%, RD/CD = 83%; P = .40) or for the percentage of days of self-monitoring of diet (FTF/CD = 81%, RD/CD = 76%; P = .45) and physical activity (FTF/CD = 76%, RD/CD = 71%; P = .41).

There was a weak negative association between participant age and weight change across 6 months (r = −0.23, P < .01). None of the other factors evaluated, including sex (r = −0.09, P = .35), race (r = −0.26, P = .15), Down syndrome diagnosis (r = 0.03, P = .81), attendance at behavioral sessions (r = −0.12, P = .24), and self-monitoring of diet (r = −0.14, P = .16) and physical activity (r = −0.11, P = .27), were associated with 6-month weight loss.

This trial was designed to evaluate strategies for reducing energy intake and the delivery of a multicomponent weight management intervention (diet, physical activity, behavioral change strategies) in a sample of adolescents with mild to moderate IDDs who were overweight or obese. Results indicated significantly greater 6-month weight loss with an eSLD (−6.4%; 53% of participants with ≥5% weight loss) compared with a CD (−2.4%; 28% of participants with ≥5% weight loss) when both interventions were delivered remotely, and no significant differences in mean weight loss between FTF delivery (−0.2%) and RD (−2.4%) when using a CD.

We are unaware of other weight loss trials that have compared an eSLD with a CD, or FTF delivery with RD in adolescents with IDD. However, these results for 6-month weight loss are consistent with those from our previous trial in 149 adults with mild to moderate IDD randomly assigned to a multicomponent intervention using an eSLD or CD, with both intervention arms delivered during monthly FTF home visits.24  Weight loss was significantly greater in the eSLD (−7.0%; ∼63% of participants with ≥5% weight loss) compared with the CD (−3.8%; ∼40% of participants with ≥5% weight loss; P < .001). The magnitude of weight loss by using the eSLD in adults with IDD (−7.0%) was similar to that observed in the current trial in adolescents with IDD (−6.4%). Together, these results suggest that the eSLD provides a viable strategy for 6-month weight loss in individuals with IDD.

The minimal 6-month weight loss observed in the current trial by using the CD delivered both FTF (−0.2%) and remotely (−2.4%) was consistent with the results from our trial in adults with IDD,24  previously described, and in other weight loss trials in adolescents6,25  and adults with IDD.26  For example, Curtin et al6  reported results from a small randomized pilot trial that compared weight loss in adolescents and young adults with Down syndrome (13–26 years) who were prescribed a conventional reduced-energy diet and increased physical activity and were randomly assigned to a 16-session nutrition and physical activity program, with (n = 11) or without (n = 10) a parent-supported behavioral intervention, delivered FTF. Weight loss achieved by using the CD was minimal in the parent-supported arm (−3.4%), whereas weight was essentially unchanged in the non–parent-supported arm (+0.6%). Results from 2 trials using the same protocol (ie, a conventional reduced-energy diet in conjunction with increased physical activity and individually delivered FTF behavioral counseling sessions) have also revealed modest weight loss (−3.3% and −4.4%) in adults with IDD whose BMI was ≥30 at baseline.26,27  Thus, the available evidence suggests that a conventional reduced-energy diet produces minimal mean 6-month weight loss in adolescents with IDD when delivered FTF in the context of a multicomponent weight management intervention.

We found no significant differences in 6-month weight loss using a CD delivered FTF (−0.2%) or remotely (−2.4%). The observation of no significant differences in weight loss between FTF and remotely delivered interventions is in agreement with results of studies conducted in samples of typically developed adults by our group28,29  and others.30  For example, we demonstrated equivalent 6-month weight loss in 295 adults with obesity who were randomly assigned to a multicomponent weight loss intervention delivered FTF (−13.4%) or in a group phone format (−12.3%).28,31  Appel et al30  compared weight loss between interventions delivered remotely (phone, study-specific Web site, and e-mails) or FTF during group and individual sessions and a self-directed control condition. Six-month weight loss was clinically relevant and similar in the remotely delivered (−6.1 kg) and the FTF groups (−5.1 kg) and minimal in controls (−1.4 kg). Thus, results from our group and others suggest that RD and FTF delivery may be viable weight management interventions with the potential for improved dissemination and reach.

Rates of attendance at behavior sessions (range 79%–86%), self-monitoring of diet (range 76%–81%) and physical activity (71%–76%) were high and did not differ significantly across intervention arms. In this trial, the FTF intervention was delivered during individual home visits; thus, differences in session attendance between FTF and RD arms that may occur when participants are required to travel to a site to attend behavioral sessions were not expected. Compliance with self-monitoring of diet and physical activity was completed by using technology in the RD arms and paper and pencil records in the FTF arm. We are unaware of comparisons of compliance with self-monitoring for diet and physical activity between technology-based and paper and pencil records in adolescents with IDD. However, the literature regarding the superiority in self-monitoring of diet and physical activity by using technology versus paper records in typically developing adolescents32  and adults is mixed.33,34 

As is commonly observed in trials in both typically developed adults and adolescents, not all participants lost weight across the 6-month intervention.28,35  Natural growth in adolescents with IDD is associated with a 2% increase in the BMI percentile per year36 ; thus, weight gain in some participants was not unexpected. In this trial, 34% of participants gained weight; however, weight gain and increased BMI of ≥3% were observed in only 12% and 10% of all participants, respectively. In addition to significantly greater weight loss observed in the RD/eSLD arm, weight gain in participants in the RD/eSLD arm was significantly lower compared with the RD/CD arm, with only 1 participant in the RD/eSLD arm gaining ≥3% of their baseline weight.

Strengths of this trial include the following: a randomized design with adequate power to evaluate the primary aims, an intervention tailored to the cognitive abilities of adolescents with IDD, intervention delivery by health educators trained and supervised by a member of the investigative team to ensure intervention fidelity, high compliance to the behavioral meeting and self-monitoring protocol, high participant retention, and assignment of the same health educator to participants in all 3 arms to reduce the potential for health educator bias. The major weakness in this trial was the inability to obtain data of sufficient quality and quantity to evaluate participant compliance with the dietary (eg, energy intake, consumption of fruits, vegetables, entrées, and low-calorie shakes) and physical activity recommendations. Problems with poor estimates of energy intake obtained by self-report records in typically developed adolescents and adults3739  have been well documented. We attempted to assess dietary intake at baseline and 6 months using an image-assisted (iPad) food record procedure on the basis of encouraging results from a previous trial from our group that suggested that this procedure may improve dietary assessment in adolescents with IDDs.40  Unfortunately, the quantity and quality of the food record data was poor. For example, <50% of participants provided valid data (eg, the average daily energy intake across 3 days was <500 kcal, participants reported forgetting what they ate or did not represent a typical day) at 6 months. These observations suggest that alternative methods of dietary assessment for adolescents with IDDs need to be developed and validated. Portable accelerometers, typically worn on a belt at the waist, are widely used to assess physical activity in typically developed populations.41,42  In this trial, <40% of participants complied with our waist-worn accelerometer protocol (minimum of four 10-hour days) because of participants’ forgetting or refusing to wear the accelerometer. Poor compliance with waist-worn accelerometer protocols in adults with IDDs has also been reported by our group43  and others.26,44,45  Participants in the remotely delivered arms used a Fitbit to self-monitor physical activity. They wore the device on ∼72% of the 168 intervention days. These observations suggest that the evaluation of the validity of accelerometers or other devices (eg, Fitbit, etc) worn at the wrist for the assessment of daily physical activity in adolescents with IDDs is warranted. Finally, these results are based on a sample of adolescents living in the community with mild to moderate IDD who were overweight or obese who volunteered and were financially incentivized to participate in a weight loss trial. Additionally, portion-controlled entrées and shakes were provided to participants in the eSLD arm, which might have contributed to the greater weight loss observed in this arm. Thus, our results may not be generalizable to adolescents with more severe IDD, over longer time frames, when using other behavioral intervention strategies, or when entrée and shakes are not provided.

Our results suggest that an eSLD, delivered remotely as part of a multicomponent weight management intervention tailored to participants’ cognitive abilities, is a viable strategy to achieve 6-month weight loss in adolescents with mild to moderate IDD who are overweight or obese. Six-month weight loss did not differ when a CD was delivered either remotely or FTF, suggesting that RD may be a viable alternative for the delivery of weight loss interventions to adolescents with IDD, with the potential for improved dissemination and reach.

We acknowledge HMR Weight Management Services Corp for providing the low-calorie shakes.

Drs Ptomey, Washburn, and Donnelly conceptualized and designed the study, coordinated and supervised data collection, drafted the initial manuscript, and reviewed and revised the manuscript; Dr Mayo conceptualized and designed the study, oversaw the initial analysis, drafted the initial manuscript, and reviewed and revised the manuscript; Drs Gorczyca, Montgomery, and Helsel, Mr Krebill, and Mr Honas designed the data collection instruments, collected data, conducted the initial analyses, and reviewed and revised the manuscript; Drs Goetz, Sullivan, and Gibson conceptualized and designed the study, coordinated and supervised data collection, and critically reviewed the manuscript for important intellectual content; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan, and the informed consent form. The data will be made available, after publication, to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to the corresponding author at lptomey@kumc.edu.

This trial has been registered at www.clinicaltrials.gov (identifier NCT02561754).

FUNDING: Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD079642). The funder did not participate in the work. Funded by the National Institutes of Health (NIH).

CD

conventional meal plan diet

COVID-19

coronavirus disease 2019

eSLD

enhanced stop light diet

FTF

face to face

IDD

intellectual and/or developmental disability

RD

remote delivery

1
Schalock
RL
,
Borthwick-Duffy
SA
,
Bradley
VJ
, et al
.
Intellectual Disability: Definition, Classification, and Systems of Supports
. 11th ed.
Washington, DC
:
American Association on Intellectual and Developmental Disabilities
;
2010
2
Maïano
C
,
Normand
CL
,
Aimé
A
,
Bégarie
J
.
Lifestyle interventions targeting changes in body weight and composition among youth with an intellectual disability: a systematic review
.
Res Dev Disabil
.
2014
;
35
(
8
):
1914
1926
3
Foley
JT
,
Lloyd
M
,
Vogl
D
,
Temple
VA
.
Obesity trends of 8-18 year old Special Olympians: 2005-2010
.
Res Dev Disabil
.
2014
;
35
(
3
):
705
710
4
Maïano
C
.
Prevalence and risk factors of overweight and obesity among children and adolescents with intellectual disabilities
.
Obes Rev
.
2011
;
12
(
3
):
189
197
5
Hales
CM
,
Fryar
CD
,
Carroll
MD
,
Freedman
DS
,
Ogden
CL
.
Trends in obesity and severe obesity prevalence in US youth and adults by sex and age, 2007-2008 to 2015-2016
.
JAMA
.
2018
;
319
(
16
):
1723
1725
6
Curtin
C
,
Bandini
LG
,
Must
A
, et al
.
Parent support improves weight loss in adolescents and young adults with Down syndrome
.
J Pediatr
.
2013
;
163
(
5
):
1402
1408. e1
7
Spear
BA
,
Barlow
SE
,
Ervin
C
, et al
.
Recommendations for treatment of child and adolescent overweight and obesity
.
Pediatrics
.
2007
;
120
(
suppl 4
):
S254
S288
8
Epstein
L
,
Squires
S
.
The Stoplight Diet for Children: An Eight-Week Program for Parents and Children
.
Boston, MA
:
Little, Brown & Co
;
1988
9
Ptomey
LT
,
Sullivan
DK
,
Lee
J
,
Goetz
JR
,
Gibson
C
,
Donnelly
JE
.
The use of technology for delivering a weight loss program for adolescents with intellectual and developmental disabilities
.
J Acad Nutr Diet
.
2015
;
115
(
1
):
112
118
10
Donnelly
JE
,
Ptomey
LT
,
Goetz
JR
, et al
.
Weight management for adolescents with intellectual and developmental disabilities: rationale and design for an 18month randomized trial
.
Contemp Clin Trials
.
2016
;
51
:
88
95
11
Mokha
JS
,
Srinivasan
SR
,
Dasmahapatra
P
, et al
.
Utility of waist-to-height ratio in assessing the status of central obesity and related cardiometabolic risk profile among normal weight and overweight/obese children: the Bogalusa Heart Study
.
BMC Pediatr
.
2010
;
10
:
73
12
Nambiar
S
,
Hughes
I
,
Davies
PS
.
Developing waist-to-height ratio cut-offs to define overweight and obesity in children and adolescents
.
Public Health Nutr
.
2010
;
13
(
10
):
1566
1574
13
Nambiar
S
,
Truby
H
,
Abbott
RA
,
Davies
PS
.
Validating the waist-height ratio and developing centiles for use amongst children and adolescents
.
Acta Paediatr
.
2009
;
98
(
1
):
148
152
14
Garnett
SP
,
Baur
LA
,
Cowell
CT
.
Waist-to-height ratio: a simple option for determining excess central adiposity in young people
.
Int J Obes (Lond)
.
2008
;
32
(
6
):
1028
1030
15
González-Agüero
A
,
Ara
I
,
Moreno
LA
,
Vicente-Rodríguez
G
,
Casajús
JA
.
Fat and lean masses in youths with Down syndrome: gender differences
.
Res Dev Disabil
.
2011
;
32
(
5
):
1685
1693
16
Institute of Medicine
.
Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids
.
Washington, DC
:
The National Academies Press
;
2002
17
US Department of Agriculture
.
MyPlate
.
Available at: https://www.myplate.gov/. Accessed January 21, 2021
18
US Department of Agriculture
;
US Department of Health and Human Services
.
Dietary Guidelines for Americans, 2010
. 7th ed.
Washington, DC
:
US Government Printing Office
;
2010
19
2018 Physical Activity Guidelines Advisory Committee
.
2018 Physical activity guidelines advisory committee scientific report
.
2018
.
20
Lohman
TG
,
Roche
AF
,
Martorell
R
.
Anthropometric Standardization Reference Manual
.
Champaign, IL
:
Human Kinetics Books
;
1988
21
Dietz
WH
.
Time to Adopt New Measures of Severe Obesity in Children and Adolescents
.
Pediatrics
.
2017
;
140
(
3
):
e20172148
22
Cole
TJ
,
Faith
MS
,
Pietrobelli
A
,
Heo
M
.
What is the best measure of adiposity change in growing children: BMI, BMI %, BMI z-score or BMI centile?
Eur J Clin Nutr
.
2005
;
59
(
3
):
419
425
23
Wei
R
,
Ogden
CL
,
Parsons
VL
,
Freedman
DS
,
Hales
CM
.
A method for calculating BMI z-scores and percentiles above the 95th percentile of the CDC growth charts
.
Ann Hum Biol
.
2020
;
47
(
6
):
514
521
24
Ptomey
LT
,
Saunders
RR
,
Saunders
M
, et al
.
Weight management in adults with intellectual and developmental disabilities: a randomized controlled trial of two dietary approaches
.
J Appl Res Intellect Disabil
.
2018
;
31
(
suppl 1
):
82
96
25
Hinckson
EA
,
Dickinson
A
,
Water
T
,
Sands
M
,
Penman
L
.
Physical activity, dietary habits and overall health in overweight and obese children and youth with intellectual disability or autism
.
Res Dev Disabil
.
2013
;
34
(
4
):
1170
1178
26
Melville
CA
,
Boyle
S
,
Miller
S
, et al
.
An open study of the effectiveness of a multi-component weight-loss intervention for adults with intellectual disabilities and obesity
.
Br J Nutr
.
2011
;
105
(
10
):
1553
1562
27
Harris
L
,
Hankey
C
,
Jones
N
, et al
.
A cluster randomised control trial of a multi-component weight management programme for adults with intellectual disabilities and obesity
.
Br J Nutr
.
2017
;
118
(
3
):
229
240
28
Donnelly
JE
,
Goetz
J
,
Gibson
C
, et al
.
Equivalent weight loss for weight management programs delivered by phone and clinic
.
Obesity (Silver Spring)
.
2013
;
21
(
10
):
1951
1959
29
Willis
EA
,
Szabo-Reed
AN
,
Ptomey
LT
, et al
.
Distance learning strategies for weight management utilizing online social networks versus group phone conference call
.
Obes Sci Pract
.
2017
;
3
(
2
):
134
142
30
Appel
LJ
,
Clark
JM
,
Yeh
HC
, et al
.
Comparative effectiveness of weight-loss interventions in clinical practice
.
N Engl J Med
.
2011
;
365
(
21
):
1959
1968
31
Lambourne
K
,
Washburn
RA
,
Gibson
C
, et al
.
Weight management by phone conference call: a comparison with a traditional face-to-face clinic. Rationale and design for a randomized equivalence trial
.
Contemp Clin Trials
.
2012
;
33
(
5
):
1044
1055
32
Jimoh
F
,
Lund
EK
,
Harvey
LJ
, et al
.
Comparing diet and exercise monitoring using smartphone app and paper diary: a two-phase intervention study
.
JMIR Mhealth Uhealth
.
2018
;
6
(
1
):
e17
33
Turner-McGrievy
GM
,
Beets
MW
,
Moore
JB
,
Kaczynski
AT
,
Barr-Anderson
DJ
,
Tate
DF
.
Comparison of traditional versus mobile app self-monitoring of physical activity and dietary intake among overweight adults participating in an mHealth weight loss program
.
J Am Med Inform Assoc
.
2013
;
20
(
3
):
513
518
34
Burke
LE
,
Conroy
MB
,
Sereika
SM
, et al
.
The effect of electronic self-monitoring on weight loss and dietary intake: a randomized behavioral weight loss trial
.
Obesity (Silver Spring)
.
2011
;
19
(
2
):
338
344
35
Epstein
LH
,
Wing
RR
,
Penner
BC
,
Kress
MJ
.
Effect of diet and controlled exercise on weight loss in obese children
.
J Pediatr
.
1985
;
107
(
3
):
358
361
36
Ptomey
LT
,
Walpitage
DL
,
Mohseni
M
, et al
.
Weight status and associated comorbidities in children and adults with Down syndrome, autism spectrum disorder and intellectual and developmental disabilities
.
J Intellect Disabil Res
.
2020
;
64
(
9
):
725
737
37
Subar
AF
,
Freedman
LS
,
Tooze
JA
, et al
.
Addressing current criticism regarding the value of self-report dietary data
.
J Nutr
.
2015
;
145
(
12
):
2639
2645
38
Schoeller
DA
,
Thomas
D
,
Archer
E
, et al
.
Self-report-based estimates of energy intake offer an inadequate basis for scientific conclusions
.
Am J Clin Nutr
.
2013
;
97
(
6
):
1413
1415
39
Burrows
T
,
Goldman
S
,
Rollo
M
.
A systematic review of the validity of dietary assessment methods in children when compared with the method of doubly labelled water
.
Eur J Clin Nutr
.
2020
;
74
(
5
):
669
681
40
Ptomey
LT
,
Willis
EA
,
Goetz
JR
,
Lee
J
,
Sullivan
DK
,
Donnelly
JE
.
Digital photography improves estimates of dietary intake in adolescents with intellectual and developmental disabilities
.
Disabil Health J
.
2015
;
8
(
1
):
146
150
41
Troiano
RP
,
Berrigan
D
,
Dodd
KW
,
Mâsse
LC
,
Tilert
T
,
McDowell
M
.
Physical activity in the United States measured by accelerometer
.
Med Sci Sports Exerc
.
2008
;
40
(
1
):
181
188
42
Bassett
DR
 Jr
,
Rowlands
A
,
Trost
SG
.
Calibration and validation of wearable monitors
.
Med Sci Sports Exerc
.
2012
;
44
(
1
,
suppl 1
):
S32
S38
43
Ptomey
LT
,
Willis
EA
,
Lee
J
, et al
.
The feasibility of using pedometers for self-report of steps and accelerometers for measuring physical activity in adults with intellectual and developmental disabilities across an 18-month intervention
.
J Intellect Disabil Res
.
2017
;
61
(
8
):
792
801
44
Melville
CA
,
Oppewal
A
,
Schäfer Elinder
L
, et al
.
Definitions, measurement and prevalence of sedentary behaviour in adults with intellectual disabilities - a systematic review
.
Prev Med
.
2017
;
97
:
62
71
45
Spanos
D
,
Hankey
CR
,
Melville
CA
.
The effectiveness of a weight maintenance intervention for adults with intellectual disabilities and obesity: a single stranded study
.
J Appl Res Intellect Disabil
.
2016
;
29
(
4
):
317
329

Competing Interests

POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.