Remote delivery of a weight management intervention for adults with intellectual disabilities: Results from a randomized non-inferiority trial.

BACKGROUND: Remote delivery of multi-component weight management interventions results in clinically meaningful weight loss in adults without intellectual disabilities (ID), but the effectiveness of remotely delivered weight management interventions in adults with ID has not previously been evaluated. OBJECTIVE: To determine if a weight management intervention delivered remotely could achieve weight loss (kg) at 6 months that is non-inferior to in-person visits in adults with ID and overweight or obesity (BMI ≥25 kg/m2). METHODS: Participants were randomized to a 24-mo. trial (6 mos weight loss,12 mos weight maintenance, 6 mos. no-contact follow up) to compare weight loss achieved with the same multicomponent intervention delivered to individual participants in their home either remotely (RD) or during face-to-face home visits (FTF). RESULTS: One hundred twenty adults with ID (∼32 years of age, 53 % females) were randomized to the RD (n = 60) or the FTF arm (n = 60). Six-month weight loss in the RD arm (-4.9 ± 7.8 kg) was superior to 6-month weight loss achieved in the FTF arm (-2.1 ± 6.7 kg, p = 0.047). However, this may be partially attributed to the COVID-19 pandemic, since weight loss in the FTF arm was greater in participants who completed the intervention entirely pre-COVID (n = 33,-3.2 %) compared to post-COVID (n = 22, -0.61 %). Weight loss across did not differ significantly between intervention arms at 18 (p = 0.33) or 24 months (p = 0.34). CONCLUSION: Our results suggest that remote delivery is a viable option for achieving clinically relevant weight loss and maintenance in adults with ID. NCT REGISTRATION: NCT03291509.

A flexible test for early-stage studies with multiple endpoints.

This paper builds on the recently proposed prediction test for muliple endpoints. The prediction test combines information across multiple endpoints while accounting for the correlation between them. The test performs well with small samples relative to the number of endpoints of interest and is flexible in the hypotheses across the individual endpoints that can be combined. The prediction test addresses a global hypothesis that is of particular interest in early-stage studies and can be used as justification for continuing on to a larger trial. However, the prediction test has several limitations which we seek to address. First, the prediction test is overly conservative when both the effect sizes across all endpoints and the number of endpoints are small. By using a parametric bootstrap to estimate the null distribution, we show that the test achieves the nominal error rate in this situation and increases the power of the test. Second, we provide a framework to allow for predictions of a difference on one or more endpoints. Finally, we extend the test with a composite null hypothesis that allows for different null hypothesized predictive abilities across the endpoints which can be especially useful if the study contains both familiar and novel endpoints. We use an example from a physical activity trial to illustrate these extensions.

Resting energy expenditure in adolescents with Down syndrome: a comparison of commonly used predictive equations.

BACKGROUND: Adolescents with Down syndrome (DS) are two to three times more likely to be obese than their typically developing peers. When preventing or treating obesity, it is useful for clinicians to understand an individual's energy intake needs. Predictive resting energy expenditure (REE) equations are often recommended for general use in energy intake recommendations; however, these predictive equations have not been validated in youth with DS. The aim of this study was to compare the accuracy of seven commonly used predictive equations for estimating REE in adolescents who are typically developing to REE measured by indirect calorimetry in adolescents with DS. METHODS: Adolescents with DS participated in a 90-min laboratory visit before 10:00 a.m. after a 12-h overnight fast and a 48-h abstention from aerobic exercise. REE was measured via indirect calorimetry, and estimated REE was derived using the Institute of Medicine, Molnar, Muller and World Health Organization equations. Mean differences between the measured and predicted REE for each equation were evaluated with equivalency testing, and P-values were adjusted for multiple comparisons using the Holm method. RESULTS: Forty-six adolescents with DS (age: 15.5 ± 1.7 years, 47.8% female, 73.9% non-Hispanic White) completed the REE assessment. Average measured REE was 1459.5 ± 267.8 kcal/day, and the Institute of Medicine equations provided the most accurate prediction of REE with a 1.7 ± 11.2% (13.9 ± 170.3 kcal/day) overestimation. This prediction was not statistically different from the measured REE [P-value = 0.582; 95% confidence interval (CI): -64.5, 36.7], and the difference between the measured and predicted REE was statistically equivalent to zero (P-value = 0.024; 90% CI: -56.1, 28.3). CONCLUSIONS: The results suggest that the Institute of Medicine equation may be useful in predicting REE in adolescents with DS. Future research should confirm these results in a larger sample and determine the utility of the Institute of Medicine equation for energy intake recommendations during a weight management intervention.

Intrapersonal, interpersonal and environmental correlates of moderate to vigorous physical activity and sedentary time in adolescents with intellectual and developmental disabilities.

BACKGROUND: Although correlates of physical activity (PA) have been extensively examined in both children and adolescents who are typically developing, little is known about correlates of moderate to vigorous physical activity (MVPA) and sedentary time in adolescents with intellectual and developmental disabilities (IDD). Therefore, we examined intrapersonal, interpersonal and environmental factors and their association with device-based MVPA and sedentary time in adolescents with IDD. METHODS: MVPA and sedentary time was assessed using a hip-worn ActiGraph model wGT3x-BT tri-axial accelerometer across a 7-day period in adolescents with IDD and one of their parents. Pearson and point-biserial correlations were calculated to inspect the associations of PA (MVPA, sedentary time) with intrapersonal factors (demographic characteristic, BMI, waist circumference, motor ability, muscle strength, grip strength, cardiovascular fitness and self-efficacy for PA), interpersonal factors (parent demographics, parent BMI, parent MVPA and sedentary time, family social support for PA, parent barriers and support for PA, parent's beliefs/attitudes towards PA and number of siblings), and environmental factors (meteorologic season and COVID-19). Ordinary least squares regression was used to estimate the unique contributions of key factors to PA after controlling for participants' age, sex, race, waist circumference and total wear time. RESULTS: Ninety-two adolescents (15.5 ± 3.0 years old, 21.7% non-White, 6.5% Hispanic, 56.5% female) provided valid accelerometer data. Average sedentary time was 494.6 ± 136.4 min/day and average MVPA was 19.8 ± 24.2 min/day. Age (r = 0.27, P = 0.01), diagnosis of congenital heart disease (r = -0.26, P = 0.01) and parent sedentary time (r = 0.30, P = 0.01) were correlated with sedentary time. BMI (r = -0.24, P = 0.03), waist circumference (r = -0.28, P = 0.01), identifying as White (r = -0.23, P = 0.03) and parent MVPA (r = 0.56, P < 0.001) were correlated with MVPA. After adjusting for the adolescent's age, sex, race, waist circumference, and total wear time, the association between parent and adolescent MVPA remained significant (b = 0.55, P < 0.01, partial η2  = 0.11). CONCLUSION: The results of this study provide evidence that race, waist circumference and parental MVPA may influence the amount of MVPA in adolescents with IDD. The limited available information and the potential health benefits of increased MVPA highlight the need to evaluate the effectiveness of multi-component interventions targeting both intrapersonal and interpersonal levels to promote increased PA in adolescents with IDD.

Changes in physical activity across a 6-month weight loss intervention in adolescents with intellectual and developmental disabilities.

BACKGROUND: Adolescents and young adults with intellectual and developmental disabilities (IDD) have high rates of obesity and low levels of physical activity. This analysis examined changes in light, moderate-to-vigorous physical activity (MVPA) and sedentary time, and the association between changes in MVPA and weight loss in adolescents and young adults with IDD and overweight and obesity participating in a 6-month multi-component weight loss intervention. METHODS: Adolescents and young adults with IDD and overweight or obesity (body mass index ≥ 85 percentile, n = 110, age ~16 years, 52.7% female) and a parent were randomised to one of three intervention groups: face-to-face delivery/conventional reduced energy diet (n = 36), remote delivery (RD)/conventional reduced energy diet (n = 39), or RD/reduced energy enhanced stop light diet (eSLD) (n = 35.) Participants were asked to engage in 60 min/day of MVPA on 5 or more days/wk. Participants and a parent attended twice monthly education/behavioural counselling sessions with a health educator to assist participants in complying with dietary and MVPA recommendations. Education/counselling in the RD arms was delivered remotely using video conferencing, and self-monitoring of MVPA and daily steps was completed using a wireless activity tracker. Education/counselling in the face-to-face arm was delivered during home-visits and self-monitoring of MVPA and daily steps was completed by self-report using paper tracking forms designed for individuals with IDD. MVPA, light activity, and sedentary time were assessed over 7 days at baseline and 6 months using a portable accelerometer (ActiGraph wGT3x-BT). RESULTS: Mixed modelling analysis completed using participants with valid accelerometer data (i.e. ≥4-10 h days) at baseline (n = 68) and 6 months (n = 30) revealed no significant changes in light, moderate- MVPA, or sedentary time across the 6-month intervention (all P > 0.05). Participants obtained 15.2 ± 21.5 min/day of MVPA at baseline and 19.7 ± 19.7 min/day at 6 months (P = 0.119). Mixed modelling indicated no significant effects of group (P = 0.79), time (P = 0.10), or group-by-time interaction (P = 0.21) on changes in MVPA from baseline to 6 months. Correlational analysis conducted on participants with valid accelerometer data at both baseline and 6 months (n = 24) revealed no significant associations between baseline sedentary time (r = 0.10, P = 0.40) and baseline MVPA (r = -0.22, P = 0.30) and change in MVPA across the 6-month intervention. Additionally, attendance at education/counselling sessions (r = 0.26, P = 0.22) and frequency of self-monitoring of MVPA were not significantly associated with change in MVPA from baseline to 6 months (r = 0.26, P = 0.44). Baseline MVPA (r = 0.02, P = 0.92) and change in MVPA from baseline to 6 months (r = 0.13, P = 0.30) were not associated with changes in body weight across the 6-month intervention. CONCLUSION: We observed a non-significant increase in MVPA (30%), which was not associated with the magnitude of weight loss in a sample of adolescents and young adults with IDD who participated in a 6-month multi-component weight loss intervention. Additional strategies to increase MVPA in adolescents and young adults with IDD participating in weight loss interventions need to be developed and evaluated.

Comparison of energy intake assessed by image-assisted food records to doubly labelled water in adolescents with intellectual and developmental disabilities: a feasibility study.

BACKGROUND: There are currently no validated methods for energy intake assessment in adolescents with intellectual and developmental disabilities (IDD). The purpose of this study was to determine the feasibility of collecting 3-day image-assisted food records (IARs) and doubly labelled water (TDEEDLW ) data in adolescents with IDD and to obtain preliminary estimates of validity and reliability for energy intake estimated by IAR. METHODS: Adolescents with IDD completed a 14-day assessment of mean daily energy expenditure using doubly labelled water. Participants were asked to complete 3-day IARs twice during the 14-day period. To complete the IAR, participants were asked to fill out a hard copy food record over three consecutive days (two weekdays/one weekend day) and to take before and after digital images of all foods and beverages consumed using an iPad tablet provided by the study. Energy intake from the IAR was calculated using Nutrition Data System for Research. Mean differences, intraclass correlations and Bland-Altman limits of agreement were performed. RESULTS: Nineteen adolescents with IDD, mean age 15.1 years, n = 6 (31.6%) female and n = 6 (31.6%) ethnic/racial minorities, enrolled in the trial. Participants successfully completed their 3-day food records and self-collected doubly labelled water urine samples for 100% of required days. Images were captured for 67.4 ± 30.1% of all meals recorded at assessment 1 and 72.3 ± 29.5% at assessment 2. The energy intake measured by IAR demonstrated acceptable test-retest reliability (intraclass correlation = 0.70). On average, IAR underestimated total energy intake by -299 ± 633 kcal/day (mean per cent error = -9.6 ± 22.2%); however, there was a large amount of individual variability in differences between the IAR and TDEEDLW (range = -1703 to 430). CONCLUSIONS: The collection of IAR and TDEEDLW is feasible in adolescents with IDD. While future validation studies are needed, the preliminary estimates obtained by this study suggest that in adolescents with IDD, the IAR method has acceptable reliability and may underestimate energy intake by ~9%.

Weight status and associated comorbidities in children and adults with Down syndrome, autism spectrum disorder and intellectual and developmental disabilities.

BACKGROUND: Little is known about body weight status and the association between body weight and common comorbidities in children and adults with Down syndrome (DS), autism spectrum disorder (ASD) and other intellectual and developmental disabilities (IDDs). METHODS: Data were extracted from the University of Kansas Medical Center's Healthcare Enterprise Repository for Ontological Narration clinical integrated data repository. Measures included demographics (sex, age and race), disability diagnosis, comorbid health conditions, height, weight and body mass index percentiles (BMI%ile; <18 years of age) or BMI (≥18 years of age). RESULTS: Four hundred and sixty-eight individuals with DS (122 children and 346 adults), 1659 individuals with ASD (1073 children and 585 adults) and 604 individuals with other IDDs (152 children and 452 adults) were identified. A total of 47.0% (DS), 41.9% (ASD) and 33.5% (IDD) of children had overweight/obese (OW/OB), respectively. Children with DS were more likely to have OW/OB compared with children with IDD or ASD [odds ratio (OR) = 1.91, 95% confidence interval (CI): (1.49, 2.46); OR = 1.43, 95% CI: (1.19, 1.72)], respectively. A total of 81.1% (DS), 62.1% (ASD), and 62.4% (IDD) of adults were OW/OB, respectively. Adults with DS were more likely to have OW/OB compared with those with IDD [OR = 2.56, 95% CI: (2.16, 3.02)]. No significant differences were observed by race. In children with ASD, higher OW/OB was associated with significantly higher (compared with non-OW/OB) occurrence of sleep apnoea [OR = 2.94, 95% CI: (2.22, 3.89)], hypothyroidism [OR = 3.14, 95% CI: (2.17, 4.25)] and hypertension [OR = 4.11, 95% CI: (3.05, 5.54)]. In adults with DS, OW/OB was significantly associated with higher risk of sleep apnoea and type 2 diabetes [OR = 2.93, 95% CI: (2.10, 4.09); OR = 1.76, 95% CI: (1.11, 2.79) respectively]. Similarly, in adults with ASD and IDD, OW/OB was significantly associated with higher risk of sleep apnoea [OR = 3.39, 95% CI: (2.37, 4.85) and OR = 6.69, 95% CI: (4.43, 10.10)], type 2 diabetes [OR = 2.25, 95 % CI: (1.68, 3.01) and OR = 5.49, 95% CI: (3.96, 7.61)] and hypertension [OR = 3.55, 95% CI: (2.76, 4.57) and 3.97, 95% CI: (3.17, 4.97)]. CONCLUSION: Findings suggest higher rates of OW/OB in individuals with DS compared with ASD and IDD. Given the increased risk of comorbidities associated with the increased risk of OW/OB, identification of effective interventions for this special population of individuals is critical.

Exploring the effectiveness of an 18-month weight management intervention in adults with Down syndrome using propensity score matching.

BACKGROUND: Down syndrome (DS) is one of the most common birth defects in the USA associated with high levels of overweight and obesity. Unique characteristics of adults with DS that may contribute to the high levels of obesity are high rates of hypothyroidism, poor muscle tone, altered gait and lower resting metabolic rate. Due to these factors, it is unknown if the same weight management interventions that are effective in adults with intellectual or developmental disability (IDD) without DS are as effective in those with DS. Therefore, the purpose of this secondary analysis was to compare changes in weight, diet and physical activity between participants with DS-related and non-DS-related IDD participating in an 18-month weight management trial. METHODS: We used propensity score methods to adjust baseline variables of overweight/obese adults with and without DS participating in an 18-month effectiveness trial with 6 months weight loss and 12 months weight maintenance. Participants followed one of two reduced calorie diet plans, obtained 150 min of moderate-vigorous intensity physical activity (MVPA) per week, and logged dietary intake daily. A health educator held monthly at-home visits with participants and a caregiver to give feedback on intervention compliance. RESULTS: Out of the 124 participants that met the criteria for inclusion, 21 were diagnosed with DS and 103 with non-DS-related IDD. Twenty out of 21 participants with DS were successfully matched. Clinically significant weight loss was seen at 18 months in participants with DS (-5.2%) and non-DS-related IDD (-6.8%), with no difference between groups (P = 0.53). Significant reductions in energy intake were seen across the 18-month intervention in both DS and non-DS-related IDD groups with between-group differences at 12 months only (1119 vs. 1492 kcal/day, respectively; P = 0.003). Although MVPA did not increase in either group across the intervention, those with non-DS-related IDD had higher levels of MVPA compared with those with DS across 18 months. CONCLUSION: Participants with DS lost a clinically significant amount of weight across the 18-month intervention. Compared with those with non-DS-related IDD, those with DS lost similar amounts of weight, had similar decreases in energy intake and participated in less MVPA across the 18-month intervention. Although individuals with DS have physiological factors that may contribute to obesity, weight management interventions designed for individuals with IDD may be equally effective in this population.

Individual and family-based approaches to increase physical activity in adolescents with intellectual and developmental disabilities: Rationale and design for an 18 month randomized trial.

Adolescents with intellectual and developmental disabilities (IDD) are less physically active and have lower cardiovascular fitness compared with their typically developing peers. This population faces additional barriers to participation in moderate-to-vigorous physical activity (MVPA) such as reliance on parents, lack of peer-support, and lack of inclusive physical activity opportunities. Previous interventions to increase MVPA in adolescents with IDD have met with limited success, at least in part due to requiring parents to transport their adolescent to an exercise facility. We recently developed a remote system to deliver MVPA to groups of adolescents with IDD in their homes via video conferencing on a tablet computer. This approach eliminates the need for transportation and provides social interaction and support from both a health coach and other participants. We will conduct a 18-mo. trial (6 mos. active, 6 mos. maintenance, 6 mos. no-contact follow-up) to compare changes in objectively assessed MVPA in 114 adolescents with IDD randomized to a single level intervention delivered only to the adolescent (AO) or a multi-level intervention delivered to both the adolescent and a parent (A + P). Our primary aim is to compare increases in MVPA (min/d) between the AO and A + P groups from 0 to 6 mos. Secondarily we will compare changes in MVPA, sedentary time, cardiovascular fitness, muscular strength, motor ability, quality of life, and the percentage of adolescents achieving the US recommendation of 60 min. MVPA/d across 18 mos. We will also explore the influence of process variables/participant characteristics on changes in MVPA across 18 mos. NCT registration: NCT03684512.

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.

BACKGROUND: Improving physical activity in adults with intellectual and developmental disabilities (IDDs) is recommended to improve weight loss and general health. However, in order to determine the success of physical activity interventions, identification of feasible methods for assessment of physical activities is necessary. The purpose of this study is to assess the feasibility of adults with IDD to track daily steps and wear an accelerometer. METHODS: Overweight/obese adults with mild to moderate IDD followed a diet and physical activity program for 18 months. All participants were asked to wear a pedometer and track steps daily by using a pedometer and to provide accelerometer data for 7 days at baseline, 6, 12 and 18 months. Adherence to the pedometer protocol and plausibility of the number of recorded steps were assessed, and these measures along with average wear time of the accelerometer were recorded. RESULTS: Data were collected from 149 participants (36.5 ± 12.2 years of age, 57% female). Participants recorded a step value on 81.5% of days across the 18-month study, with 40.9% of written days classified as plausible. When wearing the accelerometer, 26.8% of participants met the recommended 4-day/10-h wear time criterion at baseline, and 22.6, 24.8 and 18.8% met the criterion at 6, 12 and 18 months, respectively. CONCLUSIONS: Adults with IDD will adhere reasonably well to wearing a pedometer long term, but may be unable to record the step data accurately. Furthermore, adults with IDD have poor compliance with accelerometer protocols, and future studies should determine if a shorter wear time protocol would produce valid data in this population.

Caregivers' effect on weight management in adults with intellectual and developmental disabilities.

INTRODUCTION: Caregivers of adults with IDD often play a large role in the ability of adults with IDD to lose weight. OBJECTIVE: The purpose of this study was to determine to examine the effects of the caregivers' perceived burdens and self-efficacy and their relationship to an individual (family member or paid staff) on weight changes across a weight management intervention for adults with IDD. METHODS: Overweight/obese adults with mild to moderate IDD, along with assigned caregivers who served as their study partner, were randomized to an 18-month weight management intervention. The living environment and caregiver relationship were assessed at baseline. Caregivers completed questionnaires regarding perceived hassles, uplifts, and self-efficacy in helping the participant follow a weight management intervention. RESULTS: 147 adults with IDD (∼57% women and ∼16% minorities) were included in data analysis. After 18 months, there were no differences in weight loss between participants who had a family member as their study partner and those who had a paid assistant as their study partner (-5.5 ± 5.2% vs. -5.6± 5.3% p = 0.16). However, paid assistants reported more hassles with following the diet intervention at 6 months (p < 0.05). Participants who had a paid assistant as their study partner were more likely to have multiple study partners during the study, which was correlated with smaller weight loss. CONCLUSION: While caregivers are important for weight management of adults with IDD, the caregiver's relationship to the participant does not affect weight change in an intervention.

Weight management for adolescents with intellectual and developmental disabilities: Rationale and design for an 18month randomized trial.

Adolescents with intellectual and developmental disabilities (IDD) are an underserved group in need of weight management. However, information regarding effective weight management for this group is limited, and is based primarily on results from small, non-powered, non-randomized trials that were not conducted in accordance with current weight management guidelines. Additionally, the comparative effectiveness of emerging dietary approaches, such as portion-controlled meals (PCMs) or program delivery strategies such as video chat using tablet computers have not been evaluated. Therefore, we will conduct an 18month trial to compare weight loss (6months) and maintenance (7-18months) in 123 overweight/obese adolescents with mild to moderate IDD, and a parent, randomized to a weight management intervention delivered remotely using FaceTime™ on an iPad using either a conventional meal plan diet (RD/CD) or a Stop Light diet enhanced with PCMs (RD/eSLD), or conventional diet delivered during face-to-face home visits (FTF/CD). This design will provide an adequately powered comparison of both diet (CD vs. eSLD) and delivery strategy (FTF vs. RD). Exploratory analyses will examine the influence of behavioral session attendance, compliance with recommendations for diet (energy intake), physical activity (min/day), self-monitoring of diet and physical activity, medications, and parental variables including diet quality, physical activity, baseline weight, weight change, and beliefs and attitudes regarding diet and physical activity on both weight loss and maintenance. We will also complete a cost and contingent valuation analysis to compare costs between RD and FTF delivery.

A virtual reality intervention (Second Life) to improve weight maintenance: Rationale and design for an 18-month randomized trial.

Despite the plethora of weight loss programs available in the US, the prevalence of overweight and obesity (BMI≥25kg/m(2)) among US adults continues to rise at least, in part, due to the high probability of weight regain following weight loss. Thus, the development and evaluation of novel interventions designed to improve weight maintenance are clearly needed. Virtual reality environments offer a promising platform for delivering weight maintenance interventions as they provide rapid feedback, learner experimentation, real-time personalized task selection and exploration. Utilizing virtual reality during weight maintenance allows individuals to engage in repeated experiential learning, practice skills, and participate in real-life scenarios without real-life repercussions, which may diminish weight regain. We will conduct an 18-month effectiveness trial (6 months weight loss, 12 months weight maintenance) in 202 overweight/obese adults (BMI 25-44.9kg/m(2)). Participants who achieve ≥5% weight loss following a 6month weight loss intervention delivered by phone conference call will be randomized to weight maintenance interventions delivered by conference call or conducted in a virtual environment (Second Life®). The primary aim of the study is to compare weight change during maintenance between the phone conference call and virtual groups. Secondarily, potential mediators of weight change including energy and macronutrient intake, physical activity, consumption of fruits and vegetables, self-efficacy for both physical activity and diet, and attendance and completion of experiential learning assignments will also be assessed.

Portion-controlled meals provide increases in diet quality during weight loss and maintenance.

BACKGROUND: Behavioural weight-loss interventions utilising portion-controlled meals (PCMs) produce significant decreases in weight. However, their impact on diet quality during weight maintenance is unknown. The present study aimed to assess the influence of a weight management intervention employing PCMs and increased physical activity on diet quality during weight loss and weight maintenance. METHODS: One hundred and ninety-seven overweight and obese adults [67% women; mean (SD) BMI = 34.0 (4.6) kg m(-2); age = 46.1 (8.9) years] completed an 18-month trial. The weight-loss phase (0-6 months) consisted of energy restriction, which was achieved using PCMs plus fruits and vegetables and increased physical activity. During weight maintenance (6-18 months), participants consumed a diet designed to maintain weight loss. Body weight and dietary intake were assessed at baseline, and at 6, 12 and 18 months. The Healthy Eating Index-2010 (HEI) was calculated using data obtained from 3-day food records. RESULTS: Mean (SD) body weight was 14.3% (6.6%) and 8.7% (8.0%) below baseline at 6 and 18 months, respectively. The mean (SD) HEI-2010 score after weight loss [66.6 (9.4)] was significantly higher than baseline [46.4 (8.9)] and remained significantly higher than baseline at 18 months [57.7 (10.6)] (both P < 0.001). CONCLUSIONS: A weight management intervention using PCMs resulted in both clinically significant weight loss and increased diet quality scores, demonstrating that the use of PCMs during weight loss allows for meaningful changes in diet quality during weight maintenance.

Weight management for individuals with intellectual and developmental disabilities: rationale and design for an 18 month randomized trial.

Weight management for individuals with intellectual and developmental disabilities (IDD) has received limited attention. Studies on weight management in this population have been conducted over short time frames, in small samples with inadequate statistical power, infrequently used a randomized design, and have not evaluated the use of emerging effective dietary strategies such as pre-packaged meals (PMs). Low energy/fat PMs may be useful in individuals with IDD as they simplify meal planning, limit undesirable food choices, teach appropriate portion sizes, are convenient and easy to prepare, and when combined with fruits and vegetables provide a high volume, low energy dense meal. A randomized effectiveness trial will be conducted in 150 overweight/obese adults with mild to moderate IDD, and their study partners to compare weight loss (6 months) and weight maintenance (12 months) between 2 weight management approaches: 1. A Stop Light Diet enhanced with reduced energy/fat PMs (eSLD); and 2. A recommended care reduced energy/fat meal plan diet (RC). The primary aim is to compare weight loss (0-6 months) and weight maintenance (7-18 months) between the eSLD and RC diets. Secondarily, changes in chronic disease risk factors between the eSLD and RC diets including blood pressure, glucose, insulin, LDL-cholesterol, and HDL-cholesterol will be compared during both weight loss and weight maintenance. Finally, potential mediators of weight loss including energy intake, physical activity, data recording, adherence to the diet, study partner self-efficacy and daily stress related to dietary change will be explored.