Cooking Skills to Improve Long-Term Weight Loss in Young Adults With Intellectual Disabilities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Weight Loss Plus Cooking
BehavioralParticipants 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.
Traditional Weight Loss
BehavioralParticipants 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.
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: Weight Loss Plus CookingExperimental treatment 1 intervention
Group B: Traditional Weight LossActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Weight Loss Between Arms
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.
Time frame
Baseline to 18 monthsSecondary outcomes
1
Changes in Weight
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.
Time frame
Baseline to 24 months2
Activities of Daily Living
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.
Time frame
Baseline to 24 months3
Caregiver Strain
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.
Time frame
Baseline to 24 months4
Fat Mass
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.
Time frame
Baseline to 18 monthsOther outcomes
1
Skin Carotenoid Content
We will assess skin carotenoid content with a finger scan using the Veggie Meter (Longevity Link Corporation), as biomarker of fruit and vegetables intake.
Time frame
Baseline to 18 months2
Dietary Intake
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.
Time frame
Baseline to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov