Body Weight, Body Weight Changes, Developmental Disabilities, Down Syndrome, Intellectual Disability, Weight Loss
Conditions
Keywords
Diet, Obesity, Adolescents, Intellectual and Developmental Disability
Brief summary
The goal of this study is to explore the impact of two different diets (conventional vs. enhanced stop light) and two different delivery systems (face-to-face vs. remote) on weight across 18 months in overweight and obese adolescents with intellectual and developmental disabilities.
Detailed description
Rates of obesity and obesity related chronic health conditions are higher in adolescents with Intellectual and Developmental Disabilities (IDD) than those in the general population. Many of the negative health consequences observed in obese adults are already present in obese adolescents with IDD. This study is a 3 group randomized trial to evaluate the intervention delivery system and type of reduced energy diet. The investigators will randomize 123 overweight/obese adolescents with mild to moderate IDD to one of 3 groups for an 18 month trial (6 month weight loss; 12 month weight maintenance): group 1) Face-To-Face/CD group 2) Technology delivery/CD group 3) Technology delivery/eSLD. All participants will receive a progressive program of physical activity. Participants on the CD diet will be asked to consume a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet. Participants on the eSLD will consume pre-packaged portion controlled meals with the addition of 5 fruits and vegetables per day. FTF will meet with a health educator and will track progress using pen and paper records for both physical activity and diet. TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.
Interventions
DIETARY_SUPPLEMENTEnhanced Stop Light Diet (eSLD)
eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week.
DIETARY_SUPPLEMENTConventional Diet (CD)
CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.
BEHAVIORALFace-to-face (FTF)
FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet.
BEHAVIORALTechnology (TECH)
TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.
OTHERiPad with FaceTime
TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Age 13-21 yrs * Mild (IQ of 74-50) or moderate (IQ 40-49) IDD, * 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. * Overweight or obese (BMI ≥ 85th%ile on CDC growth charts, or waist circumference to height ratio \> 0.5 * Living at home with a parent or guardian. * Internet access in the home. * No plans to relocate outside the study area over the next 18 mos * Physician consent for PA and diet.
Exclusion criteria
* Insulin dependent diabetes * Participation in a weight management program involving diet and PA in the past 6 mos * Eating disorders, serious food allergies, consuming special diets, aversion to common foods, * Diagnosis of Prader-Willi Syndrome * Currently pregnant, planning on/becoming pregnant during the study. * Unable to participate in moderate to vigorous PA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change at 6 Months | Change in weight from baseline to 6 months | Participants will be weighed in shorts and a t-shirt , on a calibrated scale to the nearest 0.1 kg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change Across 18 Months | Change in weight from baseline to 18 months | Participants will be weighed in shorts and a t-shirt between 7 and 10 AM, in duplicate, on a calibrated scale to the nearest 0.1 kg. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Face-To-Face/CD Delivery: Face-to-face Diet: Conventional diet
Conventional Diet (CD): CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.
Face-to-face (FTF): FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet. | 36 |
| Technology Delivery/CD Delivery: Technology Diet: Conventional diet
Conventional Diet (CD): CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.
Technology (TECH): TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.
iPad with FaceTime: TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field. | 39 |
| Technology Delivery/eSLD Delivery: Technology Diet: enhanced Stop Light Diet
Enhanced Stop Light Diet (eSLD): eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week.
Technology (TECH): TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.
iPad with FaceTime: TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field. | 35 |
| Total | 110 |
Baseline characteristics
| Characteristic | Face-To-Face/CD | Total | Technology Delivery/eSLD | Technology Delivery/CD |
|---|---|---|---|---|
| Age, Continuous | 16.3 years STANDARD_DEVIATION 2.7 | 16.2 years STANDARD_DEVIATION 2.3 | 16.7 years STANDARD_DEVIATION 2.5 | 15.6 years STANDARD_DEVIATION 1.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 8 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 102 Participants | 31 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 97 Participants | 29 Participants | 38 Participants |
| Sex: Female, Male Female | 16 Participants | 58 Participants | 18 Participants | 24 Participants |
| Sex: Female, Male Male | 20 Participants | 52 Participants | 17 Participants | 15 Participants |
| Weight | 88.4 kg STANDARD_DEVIATION 29.5 | 81.9 kg STANDARD_DEVIATION 26.3 | 83.6 kg STANDARD_DEVIATION 26.4 | 74.9 kg STANDARD_DEVIATION 16.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 39 | 0 / 35 |
| other Total, other adverse events | 0 / 36 | 5 / 39 | 1 / 35 |
| serious Total, serious adverse events | 0 / 36 | 0 / 39 | 1 / 35 |
Outcome results
Primary
Weight Change at 6 Months
Participants will be weighed in shorts and a t-shirt , on a calibrated scale to the nearest 0.1 kg.
Time frame: Change in weight from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-To-Face/CD | Weight Change at 6 Months | -0.3 kg | Standard Deviation 5 |
| Technology Delivery/CD | Weight Change at 6 Months | -1.8 kg | Standard Deviation 4 |
| Technology Delivery/eSLD | Weight Change at 6 Months | -5.0 kg | Standard Deviation 5.9 |
Secondary
Weight Change Across 18 Months
Participants will be weighed in shorts and a t-shirt between 7 and 10 AM, in duplicate, on a calibrated scale to the nearest 0.1 kg.
Time frame: Change in weight from baseline to 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-To-Face/CD | Weight Change Across 18 Months | 1.4 kg | Standard Deviation 9.7 |
| Technology Delivery/CD | Weight Change Across 18 Months | -0.2 kg | Standard Deviation 6.6 |
| Technology Delivery/eSLD | Weight Change Across 18 Months | -2.2 kg | Standard Deviation 7.4 |