University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
NCT Number: NCT05385016
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.
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Notify Me18 year–30 year
All sexes
Interventional
Not applicable
Kansas City, Kansas, 66160, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Across 12 weeks
We will calculate the percent of participants who complete the 12 week intervention.
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.
Time frame: Change from Baseline to 12 weeks
Fitness will be assessed using the 2 minute step test.
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.
Time frame: Change from Baseline to 12 weeks
Upper body strength will be assessed by grip strength, measured using a hand dynamometer.
Time frame: Change from Baseline to 12 weeks
Standing height will be measured in duplicate with a portable stadiometer.
Time frame: Change from Baseline to 12 weeks
Participants will be weighed in duplicate, on a calibrated scale to the nearest 0.1 kg.
Time frame: Change from Baseline to 12 weeks
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
Body Mass Index will be calculated as weight (kg)/height(m) squared.
Time frame: Change from Baseline to 12 weeks
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.
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: Across 12 weeks
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
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
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: 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
University of Kansas Medical Center
Other
The Promotion of Healthy Lifestyles for Young Adults With Intellectual Disabilities
Acronym: ChefBoyID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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