Clinical trial NCT01724905: 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
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Diet
Obesity
Chronic disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight loss between experimental diet (SLDm) and recommended care diet (RC)
timeFrame: Change from Baseline in Weight at 6 months
measure: Weight loss between experimental diet (SLDm) and recommended care diet (RC)
timeFrame: Change from Baseline in Weight at 18 months
Secondary outcomes:
measure: Comparison of chronic disease factors - Blood Pressure
timeFrame: Change from Baseline in Blood Pressure at 18 months
measure: Comparison of chronic disease factors - Glucose
timeFrame: Change from Baseline in Glucose at 18 months
measure: Comparison of chronic disease factors - HDL
timeFrame: Change from Baseline in HDL-cholesterol Pressure at 18 months
measure: Comparison of chronic disease factors - LDL
timeFrame: Change from Baseline in LDL-cholesterol Pressure at 18 months
measure: Comparison of chronic disease factors - Insulin
timeFrame: Change from Baseline in Insulin Pressure at 18 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Joseph Donnelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.