Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)
NCT ID: NCT01724905
Last Updated: 2015-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
151 participants
INTERVENTIONAL
2011-05-31
2015-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Modified Stop Light Diet
Modified Stop Light Diet (SLDm)
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
Recommended Care for Weight Reduction
Recommended Care Diet
RC diet includes traditional meal plans and 35 fruits and vegetables per week
Interventions
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Modified Stop Light Diet (SLDm)
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
Recommended Care Diet
RC diet includes traditional meal plans and 35 fruits and vegetables per week
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe heart disease
* Cancer diagnosis
* Positive for HIV
18 Years
ALL
No
Sponsors
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Joseph Donnelly
OTHER
Responsible Party
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Joseph Donnelly
Professor
Principal Investigators
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Joseph Donnelly, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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18808
Identifier Type: -
Identifier Source: org_study_id