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Completed
NCT06493214
Interrupting Prolonged Sitting With ACTivity (InPACT) at Home Optimization Study
Conditions: Adherence, Treatment, Physical Inactivity
Sex: All
Ages: 8 Years – 12 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 46
Sponsor: University of Michigan
Location: University of Michigan Ann Arbor Michigan
Summary
Adherence refers to how well a person follows a recommended and agreed-upon course of action. Adherence is necessary for desired clinical outcomes and can include attending appointments, making lifestyle changes, and following home-based regimens for themselves or someone for whom they care for. Adherence to home exercise programs can be as low as 50%, directly impacting program effectiveness. There are many reasons why an individual may struggle to adhere, which may include perceived barriers such as not having enough time, reduced self-efficacy, the belief that the program is ineffective, or seeing early positive results so they then feel they do not need to continue with the program. For children, low skill level and lack of parental support are additional barriers to program adherence. A Sequential Multiple Assignment Randomized Trial (SMART) intervention is an intervention design that guides the adaptation of treatments over time. Adaptation refers to the use of dynamic information about a person (or family) to decide whether and how to intervene. SMART interventions are intended to address the unique and changing needs of individuals. The proposed study will examine the feasibility of using a 12-week (60-day) adaptive intervention design to optimize child adherence to a home exercise program. To advance equitable adherence to home exercise programs, there is a pressing need to develop strategies that support all children and families. The proposed study will provide new knowledge regarding the utility of adaptive interventions to optimize participation engagement in behavioral interventions in community contexts.
Eligibility Criteria
Inclusion Criteria:
This study will include both males and females aged 8 to 12 years and their parent/guardian from various locations in Michigan. The investigators have chosen this age group because this is a critical age with physical activity participation declines (75% from the age of 9 to 15 years). To be included in the study, participants must:
1. Have access to a computer and internet at home.
2. Be proficient in English.
Exclusion Criteria:
Children will not be eligible for the study if they meet any of the following conditions:
1. Currently taking medications (e.g., iron, metformin, chemotherapeutic agents) that could impact their ability to engage in physical activity.
2. Previously diagnosed with conditions that could impact their ability to engage in physical exercise (e.g., uncontrolled asthma).
3. Answering "YES" to any question on the Physical Activity Readiness Questionnaire (PAR-Q)22 indicating the participant has a heart condition, high BP, experienced chest pains or dizziness during daily activities, or require a doctor's recommendation for supervision during exercise.
4. Diagnosed with a physical or mental disability that would make it difficult to answer questions or follow directions without the help of an adult.
5. Parent or caregiver has a physical or mental disability that would make it difficult for them to answer questions or assist their child with project-related activities, such as completing questionnaires in the laboratory.
6. Potential participants who are ineligible will be told so on their screening call and will not be enrolled.
Source: ClinicalTrials.gov (NCT06493214). StuddyBuddy aggregates publicly available trial information.