Back to resultsWeight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Stop Light Diet (SLDm)
Recommended Care Diet
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring Diet, Obesity, Chronic disease
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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Modified Stop Light Diet
Recommended Care for Weight Reduction
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Comparison of chronic disease factors - Blood Pressure
Changes in values of blood pressure between the two groups
Comparison of chronic disease factors - Glucose
Changes in values of glucose between the two groups
Comparison of chronic disease factors - HDL
Changes in values of HDL-cholesterol between the two groups
Comparison of chronic disease factors - LDL
Changes in values of LDL-cholesterol between the two groups
Comparison of chronic disease factors - Insulin
Changes in values of insulin between the two groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01724905
Brief Title
Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)
Official Title
Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Donnelly
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Diet, Obesity, Chronic disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Stop Light Diet
Arm Type
Experimental
Arm Title
Recommended Care for Weight Reduction
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Modified Stop Light Diet (SLDm)
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Recommended Care Diet
Intervention Description
RC diet includes traditional meal plans and 35 fruits and vegetables per week
Primary Outcome Measure Information:
Title
Weight loss between experimental diet (SLDm) and recommended care diet (RC)
Description
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.
Time Frame
Change from Baseline in Weight at 6 months
Title
Weight loss between experimental diet (SLDm) and recommended care diet (RC)
Description
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.
Time Frame
Change from Baseline in Weight at 18 months
Secondary Outcome Measure Information:
Title
Comparison of chronic disease factors - Blood Pressure
Description
Changes in values of blood pressure between the two groups
Time Frame
Change from Baseline in Blood Pressure at 18 months
Title
Comparison of chronic disease factors - Glucose
Description
Changes in values of glucose between the two groups
Time Frame
Change from Baseline in Glucose at 18 months
Title
Comparison of chronic disease factors - HDL
Description
Changes in values of HDL-cholesterol between the two groups
Time Frame
Change from Baseline in HDL-cholesterol Pressure at 18 months
Title
Comparison of chronic disease factors - LDL
Description
Changes in values of LDL-cholesterol between the two groups
Time Frame
Change from Baseline in LDL-cholesterol Pressure at 18 months
Title
Comparison of chronic disease factors - Insulin
Description
Changes in values of insulin between the two groups
Time Frame
Change from Baseline in Insulin Pressure at 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Donnelly, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31944472
Citation
Ptomey LT, Willis EA, Sherman JR, White DA, Donnelly JE. Exploring the effectiveness of an 18-month weight management intervention in adults with Down syndrome using propensity score matching. J Intellect Disabil Res. 2020 Mar;64(3):221-233. doi: 10.1111/jir.12713. Epub 2020 Jan 15.
Results Reference
derived
PubMed Identifier
29311038
Citation
Ptomey LT, Steger FL, Lee J, Sullivan DK, Goetz JR, Honas JJ, Washburn RA, Gibson CA, Donnelly JE. Changes in Energy Intake and Diet Quality during an 18-Month Weight-Management Randomized Controlled Trial in Adults with Intellectual and Developmental Disabilities. J Acad Nutr Diet. 2018 Jun;118(6):1087-1096. doi: 10.1016/j.jand.2017.11.003. Epub 2018 Jan 6.
Results Reference
derived
PubMed Identifier
28707359
Citation
Ptomey LT, Willis EA, Lee J, Washburn RA, Gibson CA, Honas JJ, Donnelly JE. 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. J Intellect Disabil Res. 2017 Aug;61(8):792-801. doi: 10.1111/jir.12392.
Results Reference
derived
Learn more about this trial
Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)
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