- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06961591
- Original Trial
Cooking Skills to Improve Long-Term Weight Loss in Young Adults With Intellectual Disabilities (CHEF-ID)
The goal of this study is to see if adding hands-on cooking classes to a weight management program (called Chef-ID) helps young adults with intellectual disabilities lose more weight and keep it off compared to a standard weight loss program. The study will last 24 months and include three phases: 6 months of active support, 12 months of maintenance, and 6 months with no contact.
The investigators will look at how much weight participants lose over the first 18 months. Changes in cooking skills, body fat, health markers (like blood pressure and cholesterol), daily living skills, and caregiver stress will be tracked. Finally, factors that might help or prevent weight loss, and how changes in weight and body fat are linked to overall health will be explored.
This research will help inform on how to better support healthy lifestyles for people with intellectual disabilities.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will compare two different approaches to long-term weight loss in young adults (ages 18-30) with mild-to-moderate intellectual disabilities. One group will follow a traditional weight loss program (called eSLD), while the other will follow the same program plus take part in in-person cooking classes (called eSLD+Chef-ID). A total of 114 participants will be randomly assigned by computer to one of the two groups for a 24-month study, which includes 6 months of active support, 12 months of follow-up, and 6 months with no contact.
All participants will follow a simple diet called the "enhanced stoplight diet" and try to get at least 120 minutes of aerobic exercise and 30 minutes of strength training each week. Participants be given an iPad® with pre-recorded exercise videos, a wearable fitness tracker, and will have monthly Zoom check-ins with a health coach for 18 months.
Those in the eSLD+Chef-ID group will also attend fun, hands-on cooking classes twice a month during the first 6 months and once a month from months 7-18. Participants in the traditional eSLD group will receive short motivational video messages from their coach instead of cooking classes.
Weight will be measured at the beginning, 6, 12, 18, and 24 months. Other health measures like cooking skills, body fat, blood pressure, and caregiver stress will also be collected during lab and home visits. The goal is to find out whether learning to cook helps improve long-term weight loss and overall health in this community.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lauren Ptomey, PhD
- Phone Number: 913-588-7983
- Email: lptomey@kumc.edu
Study Contact Backup
- Name: Jessica Danon
- Phone Number: 785-764-3574
- Email: jdanon@kumc.edu
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas Medical Center
-
Contact:
- Lauren Ptomey, PhD
- Phone Number: 913-588-7983
- Email: lptomey@kumc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of mild-to-moderate intellectual disability (ID).
- 18-35 years of age.
- BMI >24.9, Body weight <350lbs.
- Sufficient functional ability to understand directions, communicate preferences, e.g., foods, wants, and can communicate through spoken language e.g., request more to eat/drink, asks for assistance with food preparation.
- 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.
- Plan to attend all study required visits over the next 24 mos.
Exclusion Criteria:
- Unable to participate in PA.
- Insulin dependent diabetes as this condition requires medical monitoring beyond the scope of this study.
- Participation in a weight management program involving diet, PA, or pharmacotherapy in the past 6 mos.
- Diagnosis of Prader-Willi Syndrome.
- Pregnancy during the previous 6 mos., currently lactating or planned pregnancy in the following 24 mos. Participants who become pregnant will be removed from the study and referred to appropriate agencies for consultation.
- Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by the PCP.
- Unwilling to be randomized.
- Unable to participate in small group, in-person instruction.
- Use of wheelchair or power chair as primary locomotion.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Weight Loss Plus Cooking
|
Participants in the eSLD+Chef-ID group will follow a healthy eating plan using the enhanced stoplight diet, meet with a health coach once a month on Zoom® using an iPad®, and aim to get 120 minutes of aerobic activity and 30 minutes of strength exercises each week. In addition, they will attend in-person cooking classes-twice a month during the first 6 months and once a month for the next 12 months. In these 60-minute classes, instructors will teach cooking skills, and participants will practice on their own or with a partner, depending on their comfort level. They will learn how to safely use kitchen tools and appliances (like ovens, blenders, knives, and measuring cups) and prepare simple meals or snacks.
Other Names:
|
|
Active Comparator: Traditional Weight Loss
|
Participants in the eSLD group will follow a healthy eating plan using the enhanced stoplight diet, meet once a month with a health coach on Zoom® using an iPad®, and aim to get 120 minutes of aerobic activity and 30 minutes of strength exercises each week. They will also receive short (2-minute) video messages from their coach-twice a month during the first 6 months and once a month after that. These videos will include feedback on their progress, reminders about their goals, and tips to help them stay on track with healthy eating and exercise.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Loss Between Arms
Time Frame: Baseline to 18 months
|
Weight will be measured in duplicate on a calibrated scale after an overnight fast during a laboratory visit at baseline, 6, 12, and 18 mos.
|
Baseline to 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Weight
Time Frame: Baseline to 24 months
|
Weight will be measured in duplicate on a calibrated scale during a laboratory visit after an overnight fast at baseline, 6, 12, and 18 mos and during a home visit at 24 mos.
|
Baseline to 24 months
|
|
Activities of Daily Living
Time Frame: Baseline to 24 months
|
Activities of Daily Living will be assessed using the 17-item Waisman Activities of Daily Living survey, which was specifically developed for and validated in adolescents and adults with intellectual disabilities.
Scores range from 0 to 34, with a higher score indicating increased independence.
|
Baseline to 24 months
|
|
Caregiver Strain
Time Frame: Baseline to 24 months
|
Caregiver strain will be assessed using the Modified Caregiver Strain Index which measures caregivers' levels of strain, a combination of stress and burden.
The index assesses 13 aspects of physical health, family finances, social interactions, time demands, and employment.
Scores range from 0 to 26, with a higher score indicating increased caregiver strain.
|
Baseline to 24 months
|
|
Fat Mass
Time Frame: Baseline to 18 months
|
Body composition will be assessed using dual energy x-ray absorptiometry (DXA -Prodigy Advance Plus, GE, Madison WI).
Pregnancy testing will be completed by all females prior to each DXA test.
All participants will wear a hospital gown during DXA scans to standardize clothing.
|
Baseline to 18 months
|
|
Fat-free Mass
Time Frame: Baseline to 18 months
|
Body composition will be assessed using dual energy x-ray absorptiometry (DXA -Prodigy Advance Plus, GE, Madison WI).
Pregnancy testing will be completed by all females prior to each DXA test.
All participants will wear a hospital gown during DXA scans to standardize clothing.
|
Baseline to 18 months
|
|
Percent Body Fat
Time Frame: Baseline to 18 months
|
Body composition will be assessed using dual energy x-ray absorptiometry (DXA -Prodigy Advance Plus, GE, Madison WI).
Pregnancy testing will be completed by all females prior to each DXA test.
All participants will wear a hospital gown during DXA scans to standardize clothing.
|
Baseline to 18 months
|
|
High-density Lipoprotein (HDL)
Time Frame: Baseline to 18 months
|
Whole blood will be drawn by a trained phlebotomist following a minimum 12-hr.
fast and sent to The University of Kansas Health Systems for analysis.
|
Baseline to 18 months
|
|
Low-density Lipoprotein (LDL)
Time Frame: Baseline to 18 months
|
Whole blood will be drawn by a trained phlebotomist following a minimum 12-hr.
fast and sent to The University of Kansas Health Systems for analysis.
|
Baseline to 18 months
|
|
Fasting Glucose
Time Frame: Baseline to 18 months
|
Whole blood will be drawn by a trained phlebotomist following a minimum 12-hr.
fast and sent to The University of Kansas Health Systems for analysis.
|
Baseline to 18 months
|
|
Hemoglobin A1c (HbA1c)
Time Frame: Baseline to 18 months
|
Whole blood will be drawn by a trained phlebotomist following a minimum 12-hr.
fast and sent to The University of Kansas Health Systems for analysis.
|
Baseline to 18 months
|
|
Resting Blood Pressure
Time Frame: Baseline to 18 months
|
Resting systolic and diastolic blood pressure will be measured on the non-dominant arm with participants seated in a chair and both feet flat on the ground.
|
Baseline to 18 months
|
|
Cooking Skills
Time Frame: Baseline to 18 months
|
Cooking skills will be assessed using the Assessment of Functional Living Skills (AFLS): Independent Living Skills.
Scores range from 48 to 336, with a lower score indicating increased independence.
|
Baseline to 18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin Carotenoid Content
Time Frame: Baseline to 18 months
|
We will assess skin carotenoid content with a finger scan using the Veggie Meter (Longevity Link Corporation), as biomarker of fruit and vegetables intake.
|
Baseline to 18 months
|
|
Dietary Intake
Time Frame: Baseline to 18 months
|
Dietary intake will be assessed using the NHANES Dietary Screener Questionnaire which is a 26 item questionnaire that asks about the past months consumption of fruits, vegetables, dairy, added sugars, whole grains, red meat and processed meat.
Based on the self-reported consumption, values for average daily intake are provided.
|
Baseline to 18 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Nutrition Disorders
- Genetic Diseases, Inborn
- Overnutrition
- Body Weight
- Body Weight Changes
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Neurodevelopmental Disorders
- Abnormalities, Multiple
- Chromosome Disorders
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Weight Loss
- Intellectual Disability
- Down Syndrome
- Technology, Industry, and Agriculture
- Industry
- Food Handling
- Food Industry
- Cooking
Other Study ID Numbers
- STUDY 160822
- R01HD116832 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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