- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05385016
Cooking Classes for Young Adults With ID (ChefBoyID)
March 26, 2024 updated by: University of Kansas Medical Center
The Promotion of Healthy Lifestyles for Young Adults With Intellectual Disabilities
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a single arm, longitudinal trial.
30 young adults with intellectual disabilities will be recruited to participate in a 12-week, healthy lifestyles intervention, delivered in person to a group of individuals with ID at the Center for Children's Healthy Lifestyles and Nutrition.
Participants will be asked to attend one 2 hr group session each week (~5-6 participants per group).
All sessions will have an education component, a hands-on nutrition/cooking lesson, and a group exercise session.
Additionally, participants will be asked to attend a 20-minute monthly individual goal setting session conducted remotely over Zoom video conferencing.
All sessions will be conducted by a trained health educator experienced in working with individuals with intellectual disabilities.
Tablet computers and Fitbit wireless activity monitors will be provided to all participants, with study issued HIPPA compliant Zoom and Fitbit accounts.
Outcome assessments will be collected at baseline and after the 12-week intervention.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lauren Ptomey, PhD
- Phone Number: 913-588-7983
- Email: lptomey@kumc.edu
Study Contact Backup
- Name: Jessica Danon, MS
- Phone Number: 785-764-3574
- Email: jdanon@kumc.edu
Study Locations
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Actively participating in another research study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Education Arm
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
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attendance
Time Frame: Across 12 weeks
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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.
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Across 12 weeks
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Retention
Time Frame: Across 12 weeks
|
We will calculate the percent of participants who complete the 12 week intervention.
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Across 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cooking Skills
Time Frame: Change from Baseline to 12 weeks
|
Cooking skills will be assessed by select questions from The Assessment of Functional Living Skills: Independent Living Skills.
Parents/caregivers will fill this survey out on behalf of the participant.
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Change from Baseline to 12 weeks
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Fitness
Time Frame: Change from Baseline to 12 weeks
|
Fitness will be assessed using the 2 minute step test.
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Change from Baseline to 12 weeks
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Lower Body Strength
Time Frame: Change from Baseline to 12 weeks
|
Lower body muscle strength will be assessed using a standard 5-repetition maximum protocol on a Cybex plate-loaded leg press calculated with the Brzycki et al. 1-repetition maximum prediction equation.
Grip strength will be measured using a hand dynamometer.
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Change from Baseline to 12 weeks
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Upper Body Strength
Time Frame: Change from Baseline to 12 weeks
|
Upper body strength will be assessed by grip strength, measured using a hand dynamometer.
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Change from Baseline to 12 weeks
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Height
Time Frame: Change from Baseline to 12 weeks
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Standing height will be measured in duplicate with a portable stadiometer.
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Change from Baseline to 12 weeks
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Weight
Time Frame: Change from Baseline to 12 weeks
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Participants will be weighed in duplicate, on a calibrated scale to the nearest 0.1 kg.
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Change from Baseline to 12 weeks
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Waist circumference
Time Frame: Change from Baseline to 12 weeks
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Waist circumference will be assessed.
Three measurements will be obtained with the outcome recorded as the average of the closest 2 measures.
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Change from Baseline to 12 weeks
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Body Mass Index
Time Frame: Change from Baseline to 12 weeks
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Body Mass Index will be calculated as weight (kg)/height(m) squared.
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Change from Baseline to 12 weeks
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Caregiver Stress
Time Frame: Change from Baseline to 12 weeks
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Caregiver stress will be assessed using the Parental Stress Scale.
The Parental Stress Scale is an 18-item questionnaire assessing parents' feelings about their parenting role, exploring both positive aspects (e.g., emotional benefits, personal development, etc.) and negative aspects of parenthood (e.g., demands on resources, feelings of stress, etc.).Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.
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Change from Baseline to 12 weeks
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Accelerometer
Time Frame: Change from Baseline to 12 weeks.
|
Physical activity will be assessed by accelerometer.
Participants will be asked to wear the accelerometer around their waist for 7 days and than return in a pre-paid envelope
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Change from Baseline to 12 weeks.
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Daily Physical Activity
Time Frame: Across 12 weeks
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Daily physical activity across the 12 week study activity will be assessed using a Fitbit Versa 3 monitor worn on the non-dominant wrist during each day of the intervention
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Across 12 weeks
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Individual Goals
Time Frame: Across 12 weeks
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Individual participant goals will be created and measured using The Goal Attainment Scale template during the individual education sessions.
At least one physical activity goal and one nutrition goal will be measured per participant.
The Goal Attainment Scale is an individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculate the extent to which a participant's goals are met.
Scores range from -2 to 2, which a higher scale indicating the most favorable outcome.
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Across 12 weeks
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Work Capacity
Time Frame: Across 12 weeks
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Changes to fitness-related outcomes will be assessed by work capacity, once per month during the group exercise sessions.
Performance will be evaluated based on the total number of rounds and repetitions (i.e., volume) of all movements completed during a 10-minute period (e.g., 3 rounds + 12 repetitions).
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Across 12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Semi Structure Interview
Time Frame: Week 12
|
Semi-structured interviews (audio recorded) will be conducted with the participant and their study partner following completion of the intervention to gather information on the overall ease and enjoyment of the program, changes in self-determination and healthy lifestyles, and suggestions to improve the intervention
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Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 24, 2022
Primary Completion (Actual)
October 31, 2023
Study Completion (Actual)
October 31, 2023
Study Registration Dates
First Submitted
May 2, 2022
First Submitted That Met QC Criteria
May 17, 2022
First Posted (Actual)
May 23, 2022
Study Record Updates
Last Update Posted (Actual)
March 28, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study 148424
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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