Cooking Classes for Young Adults With ID

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Promotion of Healthy Lifestyles for Young Adults With Intellectual Disabilities

Conditions
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Intellectual Disability, Mild to Moderate

Intervention / Treatment
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* Behavioral: Cooking Skills
* Behavioral: Physical Activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education Arm<br>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 Skills<br>* 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.<br>Behavioral: Physical Activity<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline to 12 weeks | 
| Physical Function | Physical Function will be assessed using the 8ft up and go. | Change from Baseline to 12 weeks | 
| Balance | Balance will be assessed using the Y balance test. | Change from Baseline to 12 weeks | 
| Fitness | Fitness will be assessed using the 2 minute step test. | 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. | Change from Baseline to 12 weeks | 
| Upper Body Strength | Upper body strength will be assessed by grip strength, measured using a hand dynamometer. | Change from Baseline to 12 weeks | 
| Height | Standing height will be measured in duplicate with a portable stadiometer. | Change from Baseline to 12 weeks | 
| Weight | Participants will be weighed in duplicate, on a calibrated scale to the nearest 0.1 kg. | 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. | Change from Baseline to 12 weeks | 
| Body Mass Index | Body Mass Index will be calculated as weight (kg)/height(m) squared. | Change from Baseline to 12 weeks | 
| 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 | 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. | 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 | 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 | 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. | 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). | Across 12 weeks |