Intellectual Disability, Mild to ModerateChefBoyIDNCT05385016
Cooking Classes for Young Adults With ID
A study testing Cooking Skills and Physical Activity in people with Intellectual Disability, Mild to Moderate, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Intellectual Disability, Mild to Moderate
- What is being tested?
- Cooking Skills and Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Actively participating in another research study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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.
Read the 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.
- Being tested
- Cooking Skills, Physical Activity
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooking SkillsBehavioural
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.
Physical ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Cooking Skills; Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Across 12 weeks
Retention
We will calculate the percent of participants who complete the 12 week intervention.
Measured: Across 12 weeks
Secondary outcomes (13)
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.
Measured: Change from Baseline to 12 weeks
Fitness
Fitness will be assessed using the 2 minute step test.
Measured: Change from Baseline to 12 weeks
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.
Measured: Change from Baseline to 12 weeks
Upper Body Strength
Upper body strength will be assessed by grip strength, measured using a hand dynamometer.
Measured: Change from Baseline to 12 weeks
Height
Standing height will be measured in duplicate with a portable stadiometer.
Measured: Change from Baseline to 12 weeks
Weight
Participants will be weighed in duplicate, on a calibrated scale to the nearest 0.1 kg.
Measured: Change from Baseline to 12 weeks
Waist circumference
Waist circumference will be assessed. Three measurements will be obtained with the outcome recorded as the average of the closest 2 measures.
Measured: Change from Baseline to 12 weeks
Body Mass Index
Body Mass Index will be calculated as weight (kg)/height(m) squared.
Measured: Change from Baseline to 12 weeks
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.
Measured: Change from Baseline to 12 weeks
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
Measured: Change from Baseline to 12 weeks.
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
Measured: Across 12 weeks
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.
Measured: Across 12 weeks
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).
Measured: Across 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start24 May 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intellectual Disability, Mild to ModerateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385016
- Sponsor's protocol ID
- Study 148424
- Acronym
- ChefBoyID
- Status last verified
- Mar 2024
- First submitted
- 2 May 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39648079
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Promotion of Healthy Lifestyles for Young Adults With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT05385016
- Acronym / sponsor ID
- ChefBoyID / Study 148424
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education Arm | Experimental | Behavioral: Cooking Skills, Behavioral: Physical ActivityParticipants 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Actively participating in another research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooking SkillsThis 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. | Behavioural | Education Arm |
| Physical ActivityThis 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. | Behavioural | Education Arm |
Primary outcome
Attendance
Time frame: Across 12 weeks
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
Time frame: Across 12 weeks
We will calculate the percent of participants who complete the 12 week intervention.
13 secondary outcomes
Cooking Skills
Time frame: Change from Baseline to 12 weeks
Fitness
Time frame: Change from Baseline to 12 weeks
Lower Body Strength
Time frame: Change from Baseline to 12 weeks
Upper Body Strength
Time frame: Change from Baseline to 12 weeks
Height
Time frame: Change from Baseline to 12 weeks
Weight
Time frame: Change from Baseline to 12 weeks
Waist circumference
Time frame: Change from Baseline to 12 weeks
Body Mass Index
Time frame: Change from Baseline to 12 weeks
Caregiver Stress
Time frame: Change from Baseline to 12 weeks
Accelerometer
Time frame: Change from Baseline to 12 weeks.
Daily Physical Activity
Time frame: Across 12 weeks
Individual Goals
Time frame: Across 12 weeks
Work Capacity
Time frame: Across 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 39648079Danon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooking Skills and Physical Activity in people with Intellectual Disability, Mild to Moderate, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: Across 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05385016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.