NCT05385016

Brief Summary

The purpose of this study is to examine the feasibility and initial efficacy of a healthy lifestyles intervention for the prevention of weight gain and the promotion of basic life skills related to improving health in transition age young adults with intellectual disabilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

May 24, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

May 2, 2022

Last Update Submit

March 26, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Attendance

    The health coach will record attendance at all sessions. The outcome variable will be the percentage of attendance out of the total 12 scheduled exercise sessions attended.

    Across 12 weeks

  • Retention

    We will calculate the percent of participants who complete the 12 week intervention.

    Across 12 weeks

Secondary Outcomes (13)

  • Cooking Skills

    Change from Baseline to 12 weeks

  • Fitness

    Change from Baseline to 12 weeks

  • Lower Body Strength

    Change from Baseline to 12 weeks

  • Upper Body Strength

    Change from Baseline to 12 weeks

  • Height

    Change from Baseline to 12 weeks

  • +8 more secondary outcomes

Other Outcomes (1)

  • Semi Structure Interview

    Week 12

Study Arms (1)

Education Arm

EXPERIMENTAL

Participants will attend weekly two hour small group instruction sessions. All sessions will have an education component, a hands-on nutrition/cooking lesson, and a group exercise session. Two health educators will be present during group sessions with one leading

Behavioral: Cooking SkillsBehavioral: Physical Activity

Interventions

Cooking SkillsBEHAVIORAL

This session will consist of a hands-on cooking demonstration in a demo kitchen. Skills addressed in this portion of the session will include proper kitchen utensil and appliance use, measuring dry and wet ingredients, following/reading a recipe, preparing ingredients, cooking a meal, etc. The participant will follow a visual recipe that provides a breakdown of each skill needed to complete each step of the recipe. Additionally, during the cooking session investigators will address nutrition topics related to food/kitchen safety, basic nutrition education (i.e., portion sizes, food groups, reading food labels, meal planning etc.) in a discussion format.

Education Arm

This session will consist of a group functional fitness class. Each session will include a warm-up (\~5 min) moderate-to-vigorous intensity aerobic and resistance exercise (\~20 min) and cool-down/stretching (\~5 min). Exercises may be accompanied by music and will include walking/jogging, dancing, imitating animal movements, vertical/horizontal jumps, squats, hurdles, walking on balance beam etc. Thera-Band, kettle bells, free weights, and medicine balls will be used during strength exercises for major muscle groups. These sessions will be led by certified personal trainers with experience in adaptive physical activity.

Education Arm

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of an Intellectual Disability.
  • Age: 18-30 yrs.
  • Functional ability sufficient to understand directions and to communicate through spoken language.
  • Reside in a supported living condition either at home or with no more than 1-4 residents and have a study partner (i.e., parent, staff who agrees to serve as support partner).
  • Wireless Internet access in the home.
  • Ability to walk without assistance.
  • Consent from physician to do physical activity.

You may not qualify if:

  • Actively participating in another research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Danon JC, Koon L, Sherman JR, Rice AM, Quaife S, Helsel BC, Bodde A, Ptomey LT. Feasibility and preliminary efficacy of a skill-based lifestyle intervention for enhancing cooking abilities and physical fitness in young adults with intellectual disabilities. Disabil Health J. 2025 Apr;18(2):101767. doi: 10.1016/j.dhjo.2024.101767. Epub 2024 Dec 4.

MeSH Terms

Conditions

Intellectual Disability

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 23, 2022

Study Start

May 24, 2022

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

March 28, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations