Weight Management for Adolescents With IDD
Phase: NA
Conditions: Developmental Disabilities, Weight Loss, Body Weight, Down Syndrome, Body Weight Changes, Intellectual Disability
Sponsor: University of Kansas Medical Center

 
 
 
 
 
 
 
 
 
 
Weight Management for Adolescents with Intellectual and Developmental Disabilities 
NCT02561754 
Protocol and Analysis Plan 
Last updated 3/30/2020 

Aims and Hypothesis 
 
Rates of obesity and obesity related chronic health conditions are higher in adolescents with Intellectual 
and Developmental Disabilities (IDD) than in the general population. Current data also indicate that many of 
the negative health consequences observed in obese adults are already present in obese adolescents with 
IDD. Healthy People 2020, the National Institute on Disability and Rehabilitation Research, and the Surgeon 
General’s Report on Health and Wellness of People with Disabilities all recommend additional efforts to 
decrease the high prevalence of obesity among children, adolescents, and adults with disabilities. To further 
illustrate the need for and interest in effective strategies to reduce obesity in individuals with special needs, 
NIH has recently released FOA PA-11-039 “Understanding and Treating Co-Morbid Conditions in Adolescents 
with Intellectual and Developmental Disabilities,” and PAR-13-213 “Outcome Measures for use in Treatment 
Trials for Individuals with Intellectual and Developmental Disabilities.” This has been followed by an RFA from 
the Maternal and Child Health Bureau “Research Network on Promoting Healthy Weight among Children with 
Autism Spectrum Disorders and other Special Health Care Needs,” (HRSA-13-184). The NIH RePORTER 
System includes only 4 studies (1 experimental trial) examining weight management for adolescents with IDD. 
In preliminary studies, we have demonstrated clinically significant weight loss with behavioral interventions 
guided by Social Cognitive Theory using energy restriction via an enhanced Stop Light Diet (eSLD = SLD + 
portion-controlled meals) and increased physical activity (PA) in both adults (DK83539-ongoing) and 
adolescents with IDD. In both our adult pilot and our on-going NIH adult trial we delivered the intervention 
(diet/PA) to the participant and their care provider during a face-to-face (FTF) home visit, and used 
conventional paper and pencil data reporting (diet/PA) for self-monitoring and participant feedback. In our 
recently completed 2 mo pilot weight loss trial in 20 adolescents with IDD we delivered the behavioral 
intervention to the participant and a parent using FaceTimeTM via an iPad and used commercially available 
web-based applications for self-monitoring and participant feedback for both dietary intake (Lose it!) and daily 
PA (Fitbit electronic step counter). Based on the encouraging results from our adolescent pilot using a 
technology driven intervention, which allowed for timely and targeted participant feedback and the need for 
effective, scalable weight management programs for adolescents with IDD, we are proposing an adequately 
powered, 18 mo trial (6 mo weight loss; 12 mo maintenance). We will randomize 123 adolescents with mild to 
moderate IDD to 1 of 3 groups: FTF delivery /conventional energy reduced meal plan diet (FTF/CD), 
technology delivery/CD (TECH/CD), and TECH/enhanced Stop Light Diet (TECH/eSLD). The FTF intervention 
will be delivered during home visits and self-monitoring will be completed using conventional paper and pencil 
reporting of diet and PA via pedometer. TECH groups will receive an identical weight management intervention 
delivered via FaceTimeTM using an iPad and commercially available web-based applications for self- 
monitoring and participant feedback for both dietary intake (Lose it!) and PA (Fitbit). Our study will compare 1) 
diets and 2) delivery systems and will address the following aims: 
 
Primary aim: To compare weight loss from 0-6 months between groups randomized to FTF/CD, TECH/CD 
and TECH/eSLD. This design will provide comparisons of both delivery systems (FTF/CD vs.TECH/CD) and 
diets (TECH/CD vs. TECH/eSLD). We expect significantly greater weight loss for TECH/CD compared to 
FTF/CD and significantly greater weight loss for TECH/eSLD compared to TECH/CD. 
 
Secondary aims. 1) Weight Maintenance. To compare weight maintenance from mos 7-18 between groups 
randomized to FTF/CD, TECH/CD, or TECH/eSLD. We expect significantly greater weight maintenance for 
TECH/CD compared to FTF/CD and greater weight maintenance for TECH/eSLD compared to TECH/CD. 2) 
Cost Analysis. We will conduct a cost analysis and contingent valuation analysis to compare costs between the 
FTF and TECH delivery systems. Based on our experience in delivery of weight management with technology 
(“Equivalent weight loss with phone or clinic weight management programs” DK76063, “Virtual reality to 
improve weight maintenance” DK94833), we expect TECH/CD to be less expensive compared to the FTF/CD 
intervention. 
 
Exploratory aims. We will examine energy balance variables (dietary intake, PA), process variables (self- 
monitoring, meeting attendance), parental diet and PA, parental baseline weight and weight change, and 
psychosocial variables (parents beliefs and attitudes regarding nutrition and PA) to assess their influence on 
weight loss (mos 0-6) and on weight maintenance (mos 7-18). 

Rationale 
There is virtually no information regarding the comparative effectiveness of dietary approaches or 
methods of delivery for weight management (loss/maintenance) in adolescents with IDD. As previously 
described, the characteristics of adolescents with IDD, and the altered dynamics of interactions with parents 
and siblings preclude extrapolation of weight management results from trials of normally developed adults or 
adolescents to this population. We chose to compare a CD with the eSLD as the effectiveness of these diets in 
adolescents with IDD has not been established. 
The information obtained from this study will be used to increase our understanding regarding 
strategies for the effective delivery of weight management to adolescents with IDD. The risks to participants in 
this study are small and the benefits to participants and other individuals with IDD in need of weight 
management are potentially large. 
Both diets have the potential to result in clinically significant weight loss/maintenance; however, based 
on our short pilot trial (2 mos.) we expect greater weight loss/maintenance with the eSLD compared with the 
CD. Thus, if our expectations hold true, adolescents with IDD will have 2 proven weight loss/maintenance 
strategies from which to choose, depending on the magnitude of weight loss desired and personal dietary 
preferences. The traditional FTF-group delivery of weight management used in normally developed individuals 
presents burdens for time, cost, and travel and may not be feasible for parents and adolescents with IDD, and 
this may be exacerbated in rural and lower socioeconomic populations. Thus, alternative delivery strategies 
need to be evaluated in the IDD population. Although technology has been successfully used to deliver weight 
management in normally developed adolescents and adults there are no trials establishing the comparative 
effectiveness of weight management delivery systems in adolescents with IDD. Results from our 2 mo pilot trial 
demonstrated the feasibility of using currently available technology (iPad, LoseIt, Fitbit) for delivery and self- 
monitoring of weight management in this group. Therefore, we chose to compare the effectiveness of a CD 
delivered by what may be considered a usual care format (individual FTF meeting, self-monitoring by pencil 
and paper) with the same diet delivered using technology (individual meeting via FaceTime, self-monitoring via 
LoseIt! and Fitbit.). Thus, our 3 group design (FTF/CD, TECH/CD, TECH/eSLD) allows for comparisons of both 
diet (TECH/CD vs. TECH/eSLD) and delivery systems (FTF/CD vs. TECH/CD). 
 
Research Plan and Design 
 
Study Objectives. This is a randomized trial designed to test the two hypotheses: 1) the technology delivered 
intervention with CD (TECH/CD) is more effective for weight management in adolescents with IDD than FTF 
intervention with CD (FTF/CD) and 2) the technology delivered eSLD (TECH/eSLD) intervention is more 
effective than technology delivered CD (TECH/CD) for weight management in adolescents with IDD. 
 
Overview of approach. This is a randomized trial. We propose to evaluate 2 of the major components of 
weight management interventions; delivery system and type of reduced energy diet. We will randomize 123 
overweight/obese adolescents with mild to moderate IDD to one of 3 groups for an 18 mo trial (6 mo weight 
loss; 12 mo weight maintenance): Group 1: FTF delivery/CD; Group 2: TECH delivery/CD; Group 3: 
TECH/eSLD. All intervention sessions will be delivered to individual participant/parent dyads (not groups) to 
provide counseling for each parent/participants unique situation. All groups will be prescribed a program of 
increased moderate intensity PA. Participants and parents will attend optional 30-45 min sessions with a health 
educator every other week during weight loss (0-6 mos), twice per mo during the first 6 mos of weight 
maintenance (7-12 mos) and once per mo during the last 6 mos of weight maintenance (13-18 mos). The 
TECH based interventions will be delivered using FaceTimeTM which is an iPhone/iPad application (Apple 
Inc.,Cupertino,CA) that allows users to participate in real-time video conferencing. Self-monitoring for both diet 
and PA will be completed using web-based applications for diet (Lose it!) and PA (Fitbit). The FTF intervention 
will be delivered during home-visit meetings and self-monitoring will be completed by pencil and paper records. 
The primary outcome (body weight) will be assessed during a home visit by research staff in all groups on the 
following schedule: baseline (mo 0), after weight loss (mo 6), at midpoint (mo 12) and end of weight 
maintenance (mo 18) 
 
During the COVID-19 restrictions the FTF group will meet with the HE by phone call. Health educators will call 
participants at a phone number designated by the participants and their parent, from a University issued cell 
phone. 

Table 1. Approach overview by group 
 
TECH/eSLD 
TECH/CD 
FTF/CD 
Diet 
eSLD 
CD 
CD 
Meeting Format 
FaceTime 
FaceTime 
Face to face 
Self-monitoring 
(Diet) 
Lose it! Application 
Lose it! Application 
Pencil/Paper 
Self-monitoring 
(PA) 
Fitbit & Lose it! 
Fitbit & Lose it! 
Pedometer – 
Pencil/Paper 
 
iPad Function 
Intervention Delivery 
(FaceTime) Self-monitoring 
(diet/PA) 
Food photos (outcome) 
Intervention Delivery 
(FaceTime) Self- 
monitoring (diet/PA) 
Food photos (outcome) 
Food photos 
(outcome) 
 
Technology Overview: All participants will be provided with an iPad tablet computer (Apple Inc., Cupertino, 
CA). The TECH groups ipads will be pre-loaded with both the video conferencing (Facetime), Lose it! and Fitbit 
applications. The FTF group will have an ipad that will be used for use of the photo-assisted food records, and 
to play games received as an incentive for participation in the study. Downloading of other applications or 
internet browsing will be restricted on all iPads. A Fitbit Flex (Model: Flex tracker, Fitbit Inc. San Francisco, CA) 
wireless PA monitor, to document the daily PA will also be provided to all participants in the TECH group. Data 
from the Fitbit is automatically uploaded to the iPad and will be transferred to the study database on a remote 
server. Participants will be allowed to keep the iPad and Fitbit at the completion of the study. 
 
Recruitment: We will recruit participants through local community programs serving adolescents with IDD, and 
with print and web advertisements in our target area, university broadcast emails and the KUMC HERON 
database. Recruitment materials will include contact information (toll-free phone, email). Questions from 
interested parents will be addressed and initial eligibility screening will be completed via phone or email. Home 
visits will be scheduled with interested parents and potential participants to explain the project, answer 
questions, obtain parental consent and adolescent assent, and determine eligibility. Choice is a key element in 
programs for IDD populations; thus, if parent consent is obtained but adolescent assent is not obtained the 
adolescent will not be enrolled. Individuals found to be ineligible will be referred to appropriate weight 
management options. 
 
Randomization: One hundred ten participants will be stratified by BMI%ile (<95%ile, >95%ile) and then 
randomized in a 1:1:1 allocation to either FTF/CD, TECH/CD or TECH/eSLD. Randomization will be completed 
by Dr. Mayo, the study statistician. Allocation will be concealed and group assignments will be placed in sealed 
envelopes and delivered to the study coordinator. The nature of our intervention precludes blinding of the 
health educators; however, investigators, data analysts and research assistants who collect outcome data will 
be blinded to condition. 
 
Inclusion/exclusion criteria. Inclusion: 1) Age 13-21 yrs (at least 50% female) with mild (IQ of 74-50) or 
moderate (IQ 40-49) IDD. Individuals younger than age 13 will be excluded to avoid the differences in issues 
relative to weight management in younger children. A diagnosis of IDD will be determined by doctor’s 
diagnosis or IQ test results. Parents must present documentation of diagnosis to the study team before the 
participant consents to be in the study. 2) Of sufficient functional ability to understand directions, communicate 
preferences (e.g. foods), wants (e.g. more to eat/drink), and needs (e.g. assistance with food preparation) 
through spoken language. 3) Overweight or obese (BMI ≥ 85th%ile on CDC growth charts, or waist 
circumference to height ratio > 0.5 which indicates excess central adiposity in children and adolescents. 4) 
Living at home with a parent or guardian. 5) Internet access in the home. 6) No plans to relocate outside the 
study area over the next 18 mos 7) Physician consent for PA and diet. Exclusion: 1) Insulin dependent 
diabetes as they require medical monitoring beyond the scope of this study. 2) Participation in a weight 
management program involving diet and PA in the past 6 mos 3) Eating disorders, serious food allergies, 
consuming special diets (vegetarian, Atkins etc.), aversion to common foods (e.g., unwilling to consume any 
dairy products, vegetables), diagnosis of Prader-Willi Syndrome. 4) Currently pregnant, planning on/becoming 
pregnant during the study. Should pregnancy occur the participant will be removed from the study and referred 

to the appropriate agency for consultation. 5) Unable to participate in moderate to vigorous PA. Note: 
Individuals on medication for common chronic diseases (i.e., depression, blood pressure, lipids, type 2 
diabetes) or other medications that may compromise weight loss or induce weight gain will not be excluded as 
this would diminish the generalization of the results. Random assignment should provide equal distribution of 
medication use across groups. 
 
Withdrawal/Termination. The subject’s participation will be terminated by the investigator if the diet does not 
appear to be in their best interest or if the subject becomes aggressive towards the study team. To withdraw 
from the study subject’s guardian must contact the PI in writing. Once withdrawal has been received 
information will no longer be collected from them. 
 
Intervention overview 
 
The following intervention components are common to all 3 study groups. 
Orientation: Two, 90 min. home visits will be conducted by a health educator with both parents and 
participants prior to initiating the intervention. These sessions will provide detailed descriptions of both the 
dietary (eSLD or CD) and PA components of the intervention and the respective delivery system (FTF or 
TECH). Participants and parents in the TECH groups will be oriented to the use of FaceTimeTM, and the use of 
both the Lose it! and Fitbit applications for self-monitoring of diet and PA. Health educators will provide a 
tutorial on general use of the iPad, internet connectivity, etc. Participants and parents in the FTF group will be 
shown how to self-monitor diet and PA using hard copy records. 
 
Meeting schedule: There will be a FTF visit in TECH at baseline to orient parents and participants to the diet, 
and visits at mos 6,12, and 18 to distribute gift cards (see Incentives below) and to maintain rapport with 
participants. No health education will take place during these visits. All FTF group meetings will follow an 
identical schedule. Meetings will occur twice a month during months 0-12, and monthly during months 13-18. 
Meeting attendance is encouraged but not required. Meeting attendance will be recorded. 
 
Meeting duration: ~30-45 min. This duration was based on feedback from both participants and parents from 
the adolescent IDD pilot (Pilot 2). 
 
Behavioral lesson content: Lessons on behavioral strategies to improve weight loss/maintenance have been 
adopted for adolescents with IDD from our completed pilot with adults with IDD, our ongoing study with adults 
with IDD (DK83539), and our adolescent IDD pilot (Pilot 2) previously described above. Topics include social 
support, self-monitoring, planning, environmental control, self-efficacy, etc. Each lesson will be loaded into the 
iPad (TECH) or provided as paper copy (FTF). During each meeting, we will also review diet and PA data, 
current weight status, answer questions, problem-solve, and provide support. Sessions will be recorded (FTF- 
audio recording, TECH-Facetime sessions will be recorded using Quicktime software),. The recordings will be 
used to ensure all sessions are delivered according to protocol. The audio or video recordings will be saved on 
our secure server, which is protected behind a firewall. The file name will be their de-identified study ID and date of the 
recording. The only people who have access to this server are the study investigators and the study coordinator. 
These videos may remain on the server indefinitely. 
 
Energy Intake for weight loss (0-6 mos): Energy intake will be reduced 500-700 kcal/d below total daily 
energy expenditure for both diet groups (CD and eSLD). Total daily energy expenditure will be estimated using 
the Dietary Reference Intake (DRI) total energy equation for overweight boys/girls age 13-18 yrs. Dr. Sullivan 
will assure diets are both energy and nutritionally adequate for growth and development (i.e., energy intake 
>1,200 kcal/d, >20% of total energy intake from fat, RDA vitamins, minerals). 
 
Energy intake for weight maintenance (7-18 mos): Energy intake for weight maintenance will again be 
estimated using the DRI equation with consideration for growth and development and adjusted as required 
based on changes in weight. Participants experiencing weight gain will be counseled to improve compliance to 
their prescribed level of energy intake and PA during their regularly scheduled meetings with health educators. 
In our experience some participants who did not meet their weight loss goals will volitionally attempt additional 
weight loss during weight maintenance and this will neither be encouraged or discouraged. 

Prescribed PA: As in our completed adolescent pilot, we will target 60 min/d of moderate intensity PA (3-6 
METs) at least 5 days/wk (total 300 min/wk) as recommended by the CDC and American College of Sports 
Medicine. Participants will start with 45 mins/wk (or current PA level if higher) at week one and increase PA by 
15 mins/wk until reaching the 300 min/wk goal. We will promote a variety of activities including walking, 
swimming, biking, active video games (Dance Dance Revolution, etc.), and recreational sports outside of 
school using guidelines and suggestions from the “Train at Home” program of the Special Olympics 
(http:/media.specialolympics.org). If requested, Dr. Greene, an adapted PE specialist, will be available to assist 
participants and parents in modifying activities to accommodate any special needs. 
 
Self-monitoring: All groups will be encouraged to monitor their daily diet and PA behaviors over the course of 
the 18 mo trial either by traditional pen and paper records or via iPad applications. Additional details regarding 
self-monitoring are described below. 
 
Role of parent: One parent will serve as the primary family contact and be asked to provide support and 
encouragement for the participant. Although a parent will be involved, the focus of our intervention will be 
directed towards the adolescent. The parent will attend the every other week meetings with the participant to 
be aware of diet, PA, and behavioral strategies we are promoting so as to be able to assist their child in 
complying with the intervention. Specifically, the parent will be asked to provide assistance if needed, in 
following the prescribed diet (e.g., meal planning and preparation), planning and promoting PA, and self- 
monitoring of diet and PA. We recognize some parents who need to lose weight may choose to diet with the 
participant. This reflects reality and will neither be encouraged or discouraged. The effect of parental factors, 
including changes in diet and PA on participant outcomes, will be captured by our process measures described 
later in this proposal. 
 
Diet Intervention: eSLD. The original SLD, developed by Epstein for use in children (33), categorizes foods 
by energy content: red (high-avoid), yellow (moderate–consume sparingly) and green (low-consume freely) to 
correspond to a traffic light. The SLD is easy to understand/implement and thus is appropriate for adolescents 
with IDD with assistance from their parents. We will “enhance” the Stop Light Diet (eSLD) and encourage the 
consumption of 5 F/V/d and recommended high volume, low energy PCMs [2 entrees and 2 shakes/d; Health 
Management Resources (HMR), Boston, MA] which will be provided to participants during weight loss (mos 0– 
6) as part of the study protocol. PCMs from HMR are shelf-stable, do not require refrigerated storage, and can 
be prepared with a microwave (entrees) or blender (shakes). Participants will be encouraged to consume a 
minimum of 2 entrees (200-270 kcal each), 5 servings of F/V, and 3 shakes (~100 kcal each)/d. Non-caloric 
beverages will be allowed ad libitum. Participants experiencing hunger on this diet will be encouraged to 
supplement the diet with yellow or green foods per the SLD. If a participant is non-compliant with the diet 
protocol, both participant and parent will be counseled with strategies to improve compliance. PCMs will be 
provided as part of the eSLD only during weight loss (mos 0-6), and will be shipped to the participants homes 
biweekly. During weight maintenance (mos 7-18), participants will be encouraged (not required) to continue 
using PCMs. A list of recommended low calorie/fat PCMs will be provided to parents and participants at mo 7. 
 
Dietary intervention: CD. Participants prescribed a CD (FTF/CD and TECH/CD) will be asked to consume a 
nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet as recommended by 
the Academy of Nutrition and Dietetics and the USDA’s MyPlate approach. Participants will be provided 
examples of meal plans consisting of suggested servings of grains, proteins, F/V, dairy, and fats based on their 
energy needs and will be counseled on appropriate portion sizes. As per the eSLD, the consumption of 5 F/V/d 
will be encouraged. Unlike the eSLD group (TECH/eSLD), participants in the CD groups will not receive PCMs 
during weight loss (mos 0-6). To help defray any cost above that of following a normal diet (i.e. cost for 
prescribed F/V) participants in CD groups will receive $2.00/d in the form of a grocery store gift card that will be 
recharged monthly. 
 
Self-monitoring: Basics. Participants will monitor both diet and PA on a daily basis over the course of the 18 
mo trial. 

Self-Monitoring: TECH groups. Participants in both TECH groups will monitor diet and PA on an iPad 
provided as part of the study. The iPad will be preloaded with FaceTimeTM (for intervention delivery) and the 
Lose it! application (FitNow, Inc., Boston, MA) to facilitate self-monitoring. As per the pilot, access to web 
browsing, app store etc. will be blocked. Diet: Participants will log all food and beverages consumed 
(meals/snacks) using the Lose it! application by entering the food name and selecting the portion size or by 
scanning the bar code of the food item using the iPad. As a food is entered a bar showing the recommended 
dietary intake goal for each participant is displayed, providing immediate feedback of how much food 
participants have consumed during the day and how much more or less they should consume. PA: 
Participants will be asked to wear a Fitbit Flex (Model: Flex tracker, Fitbit Inc. San Francisco, CA, size 35.5 x 
28 mm) wireless activity tracker on their wrist. The Fitbit records time spent in moderate or vigorous PA that is 
automatically transferred to the Lose it! application via Bluetooth connectivity when the device is near the iPad, 
thus eliminating the need for manual data recording. The Lose it! application on the iPad provides immediate 
feedback on a participants accumulated PA relative to their goal via a graphic display. If participants engage in 
PA that cannot be recorded by the Fitbit (e.g. biking), they will be able to log the activity in the Lose it! 
application and record the information. Reminders: The Lose It! application allows reminders to be programed 
to prompt participants to record their self-monitoring PA/diet data. Reminders will be sent only if no information 
is reported for a given meal (e.g., breakfast, lunch, dinner) or goal (i.e., exercise time, steps, weight). Diet/PA 
data management: Diet and PA data on the Lose it! application are securely, immediately and automatically 
transferred via the web to the Lose it! for Wellness Professionals web site that is accessible to the health 
educator. This information will be used as motivation, to inform participant counseling for both TECH groups, 
and will be exported to a data base to be included in the process analysis described later. 
 
Self-monitoring: FTF group. Diet: The FTF group will enter diet data on paper forms. These forms, currently 
used in our ongoing adult IDD project, contain pictorial displays of food items and calorie levels that the 
participant/parent mark after consuming a food/beverage item. PA: Participants will wear an electronic 
pedometer (Omron HJ-720 ITC, Omron Healthcare, Inc., Bannockburn, IL) and record their step data on paper 
forms provided. If a participant engages in PA that cannot be recorded by the pedometer (e.g. swimming, 
biking), they will be able to log the type and duration of activity on the forms provided. Diet/PA data 
management: Diet/PA records will be collected by health educators during home visits and be used as 
motivation, to inform participant counseling for the FTF group, and entered in a data base for inclusion in the 
process analysis. 
 
Monitoring body weight. Participants’ body weight will be obtained monthly to provide feedback regarding 
weight loss/gain over the course of the 18 mo trial. Procedures for obtaining outcome weights are described 
below. TECH/CD and TECH/eSLD): Participants in the TECH groups will self-weigh during a FaceTimeTM 
session using a calibrated wireless digital scale (Model: Aria Wifi Smart Scale, Fitbit, Inc. San Francisco, CA) 
which automatically syncs with the Lose it! application and updates a visual display of weight change. FTF/CD 
group: During FTF meetings, participants will be weighed on a calibrated digital scale (Model #PS6600, 
Belfour, Saukville, WI). Health educators will provide personal weight loss “histograms” through bands of color 
coded weight ranges, with the ranges indicating approximately one BMI%ile. 
 
Incentives. TECH groups will be provided with an iPad to be used for intervention delivery and self-monitoring. 
As an incentive they will be allowed to keep the iPad at the completion of the intervention. Participants in the 
FTF/CD group will be provided an iPad only for the purpose of taking meal photos for the dietary intake 
assessment (see assessments) during the intervention. As an incentive, they will also be allowed to keep the 
iPad at study completion. No diet or PA applications will be loaded in the iPad of the FTF/CD group. In both 
FTF and TECH groups restrictions will prevent additional application downloads or Internet browsing until 
completion of the study. At this time staff will unlock all basic iPad features. As an additional incentive, 
participants in all groups who complete self-monitoring for diet and PA on 5 of 7 days/wk will be allowed to 
choose an iPad app from a list of age appropriate applications or choose to receive $1.00 on their study 
Clincard. The apps will be loaded on participant’s iPads during the monthly health educator home visits for the 
FTF group and remotely for the TECH groups. All participants and parents will receive gift cards ($15 
participants, $10 parents) for completing outcome assessments at mos 0, 6, 12, and 18. Parents who complete 
the optional questionnaires will receive $10.00 for the completion of measures at baseline, $15.00 for three 
months,and $20.00 for the completion of the final assessment at six-months using graduated rates. 

Cost to Participants. All study cost will be paid for by the study including the iPad, fitbit, and exercise 
equipment. Participants and their families will not be charged if the participant loses any of the equipment, but 
must return them at the end of the study. 
 
Intervention Deviations: As this study is intent-to-treat, all participants will be encouraged to following the 
intervention described above, however they may choose not to follow the prescribed diet, track diet /PA, attend 
meetings, or weight themselves. If a participant chooses not to follow the intervention as described, it will be 
recorded as process data and will not be considered an intervention deviation. 
 
Assessments 
Outcome assessments will be obtained at the participant’s home. 
Outcomes will be obtained at a single home visit (Table 3). From 
our experience with our adolescent IDD pilot (pilot 2) we estimate 
these assessments will require ~75 min. to complete (PA will be 
assessed across 7 days.) Assessments will be completed by 
trained study staff blinded to condition and supervised by the 
investigator named in parentheses below. All staff will receive 
refresher training and complete reliability assessments 2-3 
times/yr. 
Anthropometrics (Weight, height, BMI%ile, waist 
circumference) Participants will be weighed in shorts and a t-shirt 
between 7 and 10 AM, in duplicate, on a calibrated scale (Model 
#PS6600, Belfour, Saukville, WI) to the nearest 0.1 kg. Standing 
height will be measured in duplicate with a portable stadiometer 
(Model #IP0955, Invicta Plastics Limited, Leicester, UK). BMI%ile 
will be calculated using the CDC BMI%ile calculator for children 
and teens (http://apps.nccd.cdc.gov). Waist circumference will be 
assessed using the procedures described by Lohman et al. Three 
measurements will be obtained with the outcome recorded as the 
average of the closest 2 measures. 
Energy and macronutrient intake. Diet intake will be assessed 
during 3 consecutive days (2 wk days and 1 wk end day) starting 
the weekend prior to the outcome assessment date using 
 
 
Table 3. Outcomes Assessment 
Schedule 
Outcome 
Measure 
Weight 
Loss 
(mo 0-6) 
Maintena 
nce 
(mo 7-18) 
 
0m 
6m 
12 
m 
18 
m 
Weight & 
Height 
X 
X 
X 
X 
Waist 
Circumference 
X 
X 
X 
X 
PA 
(accelerometer 
) 
 
X 
 
X 
 
X 
 
X 
Energy & 
Macronutrient 
Intake 
 
X 
 
X 
 
X 
 
X 
Process 
(Structured 
Interviews) 
 
 
X 
Process (Self- 
Monitoring: 
Diet/PA) 
 
Continuous 
standard proxy assisted 3-day food records augmented with food photos. IDD. Participants with assistance 
from a parent (if necessary) will be asked to take before and after photos of all food and beverages consumed 
at home over 3 days with the iPad camera. Participants will complete hard-copy proxy-assisted (parent) diet 
records to account for details about food and beverage not available from photos such as skim or whole milk, 
etc. To facilitate accurate recording, instructions developed by Dr. Sullivan ("How to record your food record") 
that describes the food record and provides detailed examples to assist with the estimation of portion size, as 
well as instructions on how to take food photos, will be loaded into the iPad. Calendar prompts will be 
programmed into the iPad to remind all participants to comply with the photo/record protocol. The iPad 
automatically date and time stamps all photos for easy identification. During the outcome visit the 3-day food 
record and photos will be reviewed to clarify food record entries. The energy and macronutrients of the diet 
record information will be assessed using Nutrition Data System for Research (NDSR version 2013, University 
of Minnesota, Minneapolis, MN). 
Medication Record. At each assessment period of baseline and months 6, 12, 18 all medications the 
participant is currently taking will be documented. The information gathered will include the medication name, 
reason for taking, amount and frequency of dosage as well as the cost of the medication. This information will 
be collected to monitor any cost changes in medication throughout the study and will be included in the cost 
analysis. . 
PA-accelerometry. Participants will wear an ActiGraph Model GT3X+ accelerometer (ActiGraph LLC, 
Pensacola, FL) for 7 consecutive days on a belt over the non-dominant hip during all waking hrs. ActiGraphs 

will be distributed during regularly scheduled home visits and returned via pre-paid mail. A minimum of 10 hrs 
will constitute a valid monitored day. Parents will be asked to assist in achieving compliance with the 
monitoring protocol. The outcome variables will be the average ActiGraph counts/min and the average min/day 
spent in moderate and vigorous intensity 
 
Demographic data: Basic demographic information (age, race/ethnicity, sex, current PA level) for both 
participants and their parents will be collected at baseline. 
 
Attendance: The health coach will record attendance at all health education sessions. The participant will only 
be considered present if they complete session. 
 
Semi-structured interview: Semi-structured interviews will be conducted in a random sample of 36 
parent/participant dyads (12/group,~30% of total sample ) at 18 mos to solicit feedback on a range of topics. 
For example, parents will be asked how they learned about the study, what motivated them to enroll, their 
perceptions of the intervention, and any challenges encountered during the study. 
 
Additional assessments: 
Parents. In exploratory analysis we will assess the influence of parental diet and PA, parental weight and 
weight change, and psychosocial variables (parent’s beliefs and attitudes regarding nutrition and PA) on 
adolescent weight loss at mos 6 and 18. To minimize parental burden we will assess these factors only during 
home visits at mos 0, 6, and 18. Parent’s diet: We will use the NCI all-day fruit and vegetable screener to 
assess changes in healthy eating over the course of the intervention. 
Parent’s PA: Parent PA will be assessed using the International Physical Activity Questionnaire short form 
which has been shown to provide valid assessments of moderate/vigorous PA over the past 7 days in adults. 
Parent’s weight: To evaluate the effect of baseline parent weight and change in parent weight on change in 
adolescent weight we will assess parent weight using a calibrated scale (Model #PS6600, Belfour, Saukville, 
WI) at mos 0, 6, and 18. 
Parent’s beliefs/attitudes on diet and PA: Parent’s beliefs/attitudes on diet and PA will be assessed with an 
adapted version of the Healthy Buddies Parent Nutrition and Physical Activity Survey which has been 
previously used with parents of adolescents with IDD. Survey items assess perceptions about the child’s 
weight, beliefs about the importance and frequency of family meals, and the frequency of fast food 
consumption. Additional items will assess parents’ beliefs, attitudes, and behaviors about their family’s eating 
habits, and PA. 
Note: During the COVID-19 restrictions, a scale, diet record, accelerometer, and the parent surveys will be 
delivered to the participants home with a return shipping envelope to return to the study team. Participants will 
be asked to weight themselves on the provided scale and take a photo of the weight on their iPad which will be 
remotely sent to the study team. Height and waist circumference will not be collected. 
 
Statistical Methods 
We chose a 3 group design (FTF/CD; TECH/CD; TECH/eSLD). We considered a 2 by 2 factorial (4 group) 
design (i.e. adding FTF/eSLD); however, the sample size required for that design was in excess of 240 
participants and was considered impractical from a cost, logistical, and recruitment perspective. Our 3 group 
design allows us to compare both the effect of delivery system (FTF/CD vs.TECH/CD) and diet (TECH/CD vs. 
TECH/eSLD) in a cost efficient manner. Based on our preliminary data, we expect significantly greater weight 
loss for TECH/CD (- 4.0 kg) compared to FTF/CD (- 1.5 kg) and significantly greater weight loss for 
TECH/eSLD (-6.5 kg) compared to TECH/CD (- 4.0 kg) at 6 mos with a common standard deviation of 3.6 kg. 
Sample size estimates require 41 participants in each of the 3 groups, assuming the levels of weight loss 
described above with 80% power and a type 1 error rate of 0.025, for each of the 2 pair-wise comparisons. It 
should be noted, that if we were to run an overall ANOVA, the global test would have greater than 99% power. 
We have allowed for 20% attrition, approximately twice what occurred in the adult (8%) or adolescent pilots 
(10%). 
Analysis plan 

Analysis plan: Primary aim. Two separate two sample t-tests will be used to compare weight loss from 0-6 
mos between groups randomized to FTF/CD and TECH/CD (i.e. effect of delivery system) and TECH/CD and 
TECH/eSLD (i.e., effect of diet). We will use an intent-to-treat analysis. Procedures for handling missing data 
are described below. We will examine the impact of baseline characteristics (age, sex, race/ethnicity, baseline 
BMI%ile, and severity of IDD) along with baseline weight on weight change using linear regression controlling 
for treatment. We will also examine the main effects of each of these variables as well as the potential 
interaction effect with treatment. 
 
Analysis plan: Secondary aim 1. Weight Maintenance. In similar fashion to our primary aim, two separate 
two sample t-tests will be used to compare weight changes from 7-18 mos between groups randomized to 
FTF/CD and TECH/CD and TECH/CD and TECH/eSLD. We will use mixed linear models to compare weight 
change from 7-18 mos between treatment groups controlling for treatment and baseline weight. These 
assessments will be conducted in participants who provide a mo 6 weight since this value represents the 
baseline measure for weight maintenance. We anticipate greater loss to follow-up over time; however, we 
expect this missing data to be missing at random. Under this assumption, mixed linear models will provide 
unbiased treatment comparisons. We will assume an autoregressive correlation structure of the dependent 
variable (weight) over time, and determine if there are any time-by-treatment interactions. 
 
Analysis Plan: Cost Analysis. Cost Analysis, including medication changes, will be completed by Dr. Lee 
who provided similar analysis for the Equivalent weight loss with phone or clinic weight management programs 
(DK76063) trial. 
 
Analysis: Exploratory aims: We will examine energy balance variables (energy intake, PA), process 
variables (self-monitoring, meeting attendance), parental diet and PA, parental baseline weight and weight 
change, and psychosocial variables (parents beliefs and attitudes regarding nutrition and PA) to assess their 
influence on weight loss at mo 6 and on weight maintenance mos 7-18. To determine if treatment impacts 
these variables, we will compare changes in each variable during both weight loss (mos 0-6) and weight 
maintenance (mos 7-18) across the 3 intervention groups. We will use linear regression techniques to examine 
the impact of these variables, as well as baseline demographic characteristics (sex, age, race/ethnicity, 
BMI%ile and level of IDD), to identify the best subsets of variables that explain weight loss at mo 6 and weight 
maintenance (mos 7-18) while controlling for treatment. Note: We will examine main effects of each of these 
variables as well as the potential interaction effect with treatment. 
 
Missing data: All analyses will be based upon the intent-to-treat principle; however, true change for our 
primary aim will only be measurable in participants with data at baseline (mo 0) and following weight loss (mo 
6). Missing data for analyses of both our primary (weight loss 0-6 mos) and secondary aims (weight 
maintenance 7-18 mos) will be imputed using multiple imputations. For our longitudinal comparisons of 
endpoints during weight maintenance if the data is missing at random or covariate missing at random, then the 
mixed model estimates are unbiased in the presence of this missing data. Therefore, we will determine if 
missing data are related to treatment or initial amount of weight loss. If not, we will not impute, if so, we will use 
model based multiple imputation techniques. All statistical procedures will be performed using SAS version 9.3 
or higher. 
 
Outcome: The technology delivered intervention with CD (TECH/CD) is expected to be more effective for 
weight management in adolescents with IDD than FTF intervention with CD (FTF/CD) and the technology 
delivered eSLD (TECH/eSLD) intervention is expected to be more effective than technology delivered CD 
(TECH/CD) for weight management in adolescents with IDD. The end point of the study will conclude after all 
123 study subjects have completed the study protocol.