NCT06961591

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
38mo left

Started May 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
May 2025Jul 2029

First Submitted

Initial submission to the registry

April 24, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

May 19, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

October 6, 2025

Status Verified

October 1, 2025

Enrollment Period

3.6 years

First QC Date

April 24, 2025

Last Update Submit

October 3, 2025

Conditions

Keywords

Weight Loss MaintenanceCooking SkillsWeight lossDown syndrome

Outcome Measures

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.

    Baseline to 18 months

Secondary Outcomes (12)

  • Changes in Weight

    Baseline to 24 months

  • Activities of Daily Living

    Baseline to 24 months

  • Caregiver Strain

    Baseline to 24 months

  • Fat Mass

    Baseline to 18 months

  • Fat-free Mass

    Baseline to 18 months

  • +7 more secondary outcomes

Other Outcomes (2)

  • Skin Carotenoid Content

    Baseline to 18 months

  • Dietary Intake

    Baseline to 18 months

Study Arms (2)

Weight Loss Plus Cooking

EXPERIMENTAL
Behavioral: Weight Loss Plus Cooking

Traditional Weight Loss

ACTIVE COMPARATOR
Behavioral: Traditional Weight Loss

Interventions

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.

Also known as: eSLD+Chef-ID
Weight Loss Plus Cooking

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.

Also known as: eSLD
Traditional Weight Loss

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of mild-to-moderate intellectual disability (ID).
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Intellectual DisabilityOverweightObesityWeight LossDown Syndrome

Interventions

Cooking

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightBody Weight ChangesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Food HandlingFood IndustryIndustryTechnology, Industry, and Agriculture

Central Study Contacts

Lauren Ptomey, PhD

CONTACT

Jessica Danon

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 8, 2025

Study Start

May 19, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

October 6, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations