Obesity
Conditions
Keywords
weight loss, weight management
Brief summary
The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.
Interventions
BEHAVIORALVideo Conference Meetings
Individual video conferencing with a health educator using an iPad.
BEHAVIORALIn-person Meetings
Individual face-to-face (FTF) meetings with a health educator.
BEHAVIORALEnhanced Stop Light Diet
Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.).
BEHAVIORALPhysical Activity
Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of mild to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO). Participants will be judged competent to provide informed consent by their CDDO, or will have a guardian with power of attorney. * Ability to provide assent, regardless of guardian consent. * BMI of 25 to 45 kg/m2 * 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 * Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner * No plans to relocate outside the study area over the next 24 months * Internet access in the home
Exclusion criteria
* Unable to participate in moderate-to-vigorous physical activity (MVPA) * Insulin dependent diabetes * Participation in a weight management program involving diet and physical activity in the past 6 months * Serious food allergies, consuming special diets (vegetarian, Atkins etc.), aversion to common foods (e.g., unwilling to consume dairy products, vegetables), diagnosis of Prader-Willi Syndrome * Pregnancy during the previous 6 months, currently lactating or planned pregnancy in the following 24 months. * Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty * Unwilling to be randomized.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight (kg) | Change from Baseline to Month 6 | Change in weight (kg) from baseline to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight (kg) | Change from Baseline to Month 24 | Change in weight across the 24 month study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Face to Face Participants randomized to this group will have a health educator to their house for in-person meetings. Participants will use paper forms to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.
In-person Meetings: Individual face-to-face (FTF) meetings with a health educator.
Enhanced Stop Light Diet: Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.).
Physical Activity: Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week. | 60 |
| Remote Delivery Participants randomized to this group will use an iPad to talk to the health educator via video conference meetings. Participants will use the iPad to track progress in other parts of the study. Participants will be asked follow the Enhanced Stop Light Diet (eSLD) and take part in structured physical activity each week.
Video Conference Meetings: Individual video conferencing with a health educator using an iPad.
Enhanced Stop Light Diet: Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.).
Physical Activity: Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Face to Face | Total | Remote Delivery |
|---|---|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 11.7 | 32.1 years STANDARD_DEVIATION 10.1 | 30.6 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 9 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 111 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 103 Participants | 54 Participants |
| Sex: Female, Male Female | 35 Participants | 63 Participants | 28 Participants |
| Sex: Female, Male Male | 25 Participants | 57 Participants | 32 Participants |
| Weight (kg) | 101.5 kg STANDARD_DEVIATION 27.5 | 97.9 kg STANDARD_DEVIATION 26.8 | 94.4 kg STANDARD_DEVIATION 25.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 60 | 0 / 60 |
| other Total, other adverse events | 3 / 60 | 3 / 60 |
| serious Total, serious adverse events | 1 / 60 | 1 / 60 |
Outcome results
Primary
Change in Weight (kg)
Change in weight (kg) from baseline to 6 months
Time frame: Change from Baseline to Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face to Face | Change in Weight (kg) | -2.1 kg | Standard Deviation 6.7 |
| Remote Delivery | Change in Weight (kg) | -4.9 kg | Standard Deviation 7.8 |
Secondary
Change in Weight (kg)
Change in weight across the 24 month study
Time frame: Change from Baseline to Month 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face to Face | Change in Weight (kg) | -2.3 kg | Standard Deviation 10.1 |
| Remote Delivery | Change in Weight (kg) | -4.5 kg | Standard Deviation 10.3 |