Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)

Study Overview
=================
Brief Summary
-----------------
Individuals with intellectual developmental disabilities (IDD) have obesity rates that exceed those in the general population, consume energy dense diets, and perform very little physical activity (PA). Overweight and obesity are independent risk factors for chronic disease such as cancer, diabetes, hypertension, and cardiovascular disease in both the general population and those with IDD. The investigators modified the Stop Light Diet (SLDm) to include reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week. The investigators will compare participants who use the SLDm with participants who use a reduced energy and fat diet with meal plans, based off of the current American Dietetic Association recommended car for weight reduction plan.

Official Title
-----------------
Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Dietary Supplement: Modified Stop Light Diet (SLDm)
* Dietary Supplement: Recommended Care Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of mile to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO) Able to understand and give informed consent If there is a guardian with power of attorney, both the guardian and participant must give informed consent Participants must live in a supported living condition either at home or with no more than 1-4 residents and have a care giver (ie. parent, staff) who assists with food shopping, meal planning, and meal preparation Overweight or obese determined by a BMI > 25 kg/m2 Able to walk Clearance provided from physician Able to communicate preferences Exclusion Criteria: Uncontrolled hypertension Severe heart disease Cancer diagnosis Positive for HIV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Stop Light Diet<br> | Dietary Supplement: Modified Stop Light Diet (SLDm)<br>* SLDm includes reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week<br>|
| Active Comparator: Recommended Care for Weight Reduction<br> | Dietary Supplement: Recommended Care Diet<br>* RC diet includes traditional meal plans and 35 fruits and vegetables per week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss between experimental diet (SLDm) and recommended care diet (RC) | The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg. | Change from Baseline in Weight at 6 months | 
| Weight loss between experimental diet (SLDm) and recommended care diet (RC) | The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg. | Change from Baseline in Weight at 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of chronic disease factors - Blood Pressure | Changes in values of blood pressure between the two groups | Change from Baseline in Blood Pressure at 18 months | 
| Comparison of chronic disease factors - Glucose | Changes in values of glucose between the two groups | Change from Baseline in Glucose at 18 months | 
| Comparison of chronic disease factors - HDL | Changes in values of HDL-cholesterol between the two groups | Change from Baseline in HDL-cholesterol Pressure at 18 months | 
| Comparison of chronic disease factors - LDL | Changes in values of LDL-cholesterol between the two groups | Change from Baseline in LDL-cholesterol Pressure at 18 months | 
| Comparison of chronic disease factors - Insulin | Changes in values of insulin between the two groups | Change from Baseline in Insulin Pressure at 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet, Obesity, Chronic disease