Clinical trial NCT06961591: Cooking Skills to Improve Long-Term Weight Loss in Young Adults With Intellectual Disabilities
Official title: Cooking Skills to Improve Long-Term Weight Loss in Young Adults With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intellectual Disability
Overweight and Obesity
Keywords: Weight Loss Maintenance
Cooking Skills
Weight loss
Down syndrome
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-05-08
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of mild-to-moderate intellectual disability (ID).
2. 18-35 years of age.
3. BMI \>24.9, Body weight \<350lbs.
4. 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.
5. 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.
6. Plan to attend all study required visits over the next 24 mos.

Exclusion Criteria:

1. Unable to participate in PA.
2. Insulin dependent diabetes as this condition requires medical monitoring beyond the scope of this study.
3. Participation in a weight management program involving diet, PA, or pharmacotherapy in the past 6 mos.
4. Diagnosis of Prader-Willi Syndrome.
5. 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.
6. Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by the PCP.
7. Unwilling to be randomized.
8. Unable to participate in small group, in-person instruction.
9. Use of wheelchair or power chair as primary locomotion.

Primary outcomes:
measure: Weight Loss Between Arms
timeFrame: Baseline to 18 months
Secondary outcomes:
measure: Changes in Weight
timeFrame: Baseline to 24 months
measure: Activities of Daily Living
timeFrame: Baseline to 24 months
measure: Caregiver Strain
timeFrame: Baseline to 24 months
measure: Fat Mass
timeFrame: Baseline to 18 months
measure: Fat-free Mass
timeFrame: Baseline to 18 months
measure: Percent Body Fat
timeFrame: Baseline to 18 months
measure: High-density Lipoprotein (HDL)
timeFrame: Baseline to 18 months
measure: Low-density Lipoprotein (LDL)
timeFrame: Baseline to 18 months
measure: Fasting Glucose
timeFrame: Baseline to 18 months
measure: Hemoglobin A1c (HbA1c)
timeFrame: Baseline to 18 months
measure: Resting Blood Pressure
timeFrame: Baseline to 18 months
measure: Cooking Skills
timeFrame: Baseline to 18 months
Other outcomes:
measure: Skin Carotenoid Content
timeFrame: Baseline to 18 months
measure: Dietary Intake
timeFrame: Baseline to 18 months
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References: