Cooking Classes for Young Adults With ID (ChefBoyID)
Primary Purpose
Intellectual Disability, Mild to Moderate
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cooking Skills
Physical Activity
Sponsored by
About this trial
This is an interventional prevention trial for Intellectual Disability, Mild to Moderate
Eligibility Criteria
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
Sites / Locations
- University of Kansas Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Education Arm
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Retention
We will calculate the percent of participants who complete the 12 week intervention.
Secondary Outcome Measures
Cooking Skills
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.
Physical Function
Physical Function will be assessed using the 8ft up and go.
Balance
Balance will be assessed using the Y balance test.
Fitness
Fitness will be assessed using the 2 minute step test.
Lower Body Strength
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.
Upper Body Strength
Upper body strength will be assessed by grip strength, measured using a hand dynamometer.
Height
Standing height will be measured in duplicate with a portable stadiometer.
Weight
Participants will be weighed in duplicate, on a calibrated scale to the nearest 0.1 kg.
Waist circumference
Waist circumference will be assessed. Three measurements will be obtained with the outcome recorded as the average of the closest 2 measures.
Body Mass Index
Body Mass Index will be calculated as weight (kg)/height(m) squared.
Dietary Intake
Diet intake will be assessed during 3 consecutive days (2 weekdays and 1 weekend day) starting the weekend prior to the outcome assessment date using standard proxy assisted 3-day food records augmented with food photos
Caregiver Stress
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.
Accelerometer
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
Daily Physical Activity
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
Individual Goals
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.
Work Capacity
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).
Full Information
NCT ID
NCT05385016
First Posted
May 2, 2022
Last Updated
July 19, 2022
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05385016
Brief Title
Cooking Classes for Young Adults With ID
Acronym
ChefBoyID
Official Title
The Promotion of Healthy Lifestyles for Young Adults With Intellectual Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability, Mild to Moderate
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Education Arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Cooking Skills
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attendance
Description
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.
Time Frame
Across 12 weeks
Title
Retention
Description
We will calculate the percent of participants who complete the 12 week intervention.
Time Frame
Across 12 weeks
Secondary Outcome Measure Information:
Title
Cooking Skills
Description
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.
Time Frame
Change from Baseline to 12 weeks
Title
Physical Function
Description
Physical Function will be assessed using the 8ft up and go.
Time Frame
Change from Baseline to 12 weeks
Title
Balance
Description
Balance will be assessed using the Y balance test.
Time Frame
Change from Baseline to 12 weeks
Title
Fitness
Description
Fitness will be assessed using the 2 minute step test.
Time Frame
Change from Baseline to 12 weeks
Title
Lower Body Strength
Description
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.
Time Frame
Change from Baseline to 12 weeks
Title
Upper Body Strength
Description
Upper body strength will be assessed by grip strength, measured using a hand dynamometer.
Time Frame
Change from Baseline to 12 weeks
Title
Height
Description
Standing height will be measured in duplicate with a portable stadiometer.
Time Frame
Change from Baseline to 12 weeks
Title
Weight
Description
Participants will be weighed in duplicate, on a calibrated scale to the nearest 0.1 kg.
Time Frame
Change from Baseline to 12 weeks
Title
Waist circumference
Description
Waist circumference will be assessed. Three measurements will be obtained with the outcome recorded as the average of the closest 2 measures.
Time Frame
Change from Baseline to 12 weeks
Title
Body Mass Index
Description
Body Mass Index will be calculated as weight (kg)/height(m) squared.
Time Frame
Change from Baseline to 12 weeks
Title
Dietary Intake
Description
Diet intake will be assessed during 3 consecutive days (2 weekdays and 1 weekend day) starting the weekend prior to the outcome assessment date using standard proxy assisted 3-day food records augmented with food photos
Time Frame
Change from Baseline to 12 weeks
Title
Caregiver Stress
Description
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.
Time Frame
Change from Baseline to 12 weeks
Title
Accelerometer
Description
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
Time Frame
Change from Baseline to 12 weeks.
Title
Daily Physical Activity
Description
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
Time Frame
Across 12 weeks
Title
Individual Goals
Description
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.
Time Frame
Across 12 weeks
Title
Work Capacity
Description
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).
Time Frame
Across 12 weeks
Other Pre-specified Outcome Measures:
Title
Semi Structure Interview
Description
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
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Ptomey, PhD
Phone
913-588-7983
Email
lptomey@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Danon, MS
Phone
785-764-3574
Email
jdanon@kumc.edu
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Ptomey, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Cooking Classes for Young Adults With ID
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