Interrupting Prolonged Sitting With ACTivity (InPACT) at Home Optimization Study
NCT Number: NCT06493214
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adherence, Treatment|Physical Inactivity
Interventions: BEHAVIORAL: Physical activity
Sponsor: University of Michigan
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-05
Completion Date: 2025-07-15
Locations: University of Michigan, Ann Arbor, Michigan, 48109, United States

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.

Primary Outcome Measures: Dose of exercise received, Dose will be measured by identifying the number of participants who complete 40 or more of the 60 videos (averaging 2 videos per day). The self-reported average number of total videos completed over the 60-day intervention will be recorded on the activity calendar sheets. To ensure accuracy, parents will sign off on the logs at the end of each week. Like other studies, video view duration will be assessed using YouTube analytics. To validate child physical activity, child participants will be requested to wear a physical activity wrist monitor (FitBit) during each activity break. This objective measure aims to confirm the level of activity during the video sessions. Established procedures for device placement, initialization, and processing, which have undergone validation, will be strictly adhered to during this process., Mid-treatment (4 and 8 weeks), immediately post-treatment
Secondary Outcome Measures: Attrition, Attrition will be determined by calculating the total number of participants who drop out., Mid-treatment (4 and 8 weeks), immediately post-treatment|Dose of intervention supports received, Dose of intervention supports will be quantified as attendance at weekly coaching sessions (coaching) and text message reads (pings) throughout the intervention period31. Research staff will document dose., Mid-treatment (4 and 8 weeks), immediately post-treatment
Other Outcome Measures: Physical activity enjoyment scale, Enjoyment will be assessed using the Physical Activity Enjoyment Scale (PACES) questionnaire. Participants will be asked to reflect on how they felt about the exercises. Example questions include the following: "When I was active . . . I enjoyed it, When I was active . . . I felt bored; When I was active . . . it frustrated me." The scale is a combination of 16 positive and negative statements. The responses are scored on a 5-point Likert scale, 1 (disagree a lot) to 5 (agree a lot). Seven of the 16 statements were reverse coded. An enjoyment score is calculated by averaging the scores. The revised Physical Activity Enjoyment Scale has been validated in children and demonstrated high reliability in the present analysis (Cronbach alpha= 0.91). The scale ranges from 0 to 48. PACES scores below 24 are interpreted as lower enjoyment while being physically active., baseline, 1-week post-treatment|Physical activity questionnaire for children, Pre- and post- physical activity levels will be assessed using the Physical Activity Questionnaire for Children (PAQ-C). Questionnaire items are scored (range 1 to 5) and a score of 1 indicated low physical activity and a score of 5 indicated high physical activity. This questionnaire has been validated for children ages 7-14 years old of all races., baseline, 1-week post-treatment|Anxiety symptoms, Anxiety symptoms will be assessed using the General Anxiety Disorder-7 (GAD-7). GAD-7 consists of seven items measuring worry and anxiety symptoms. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21; higher scores reflecting greater anxiety severity. Scores above 10 are in the clinical range The GAD-7 has shown good reliability and construct validity., baseline, 1-week post-treatment|Depression symptoms, Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). PHQ-9 consists of nine items measuring depressive symptoms corresponding to the diagnostic criteria for major depressive disorder. Each item is scored on a four-point Likert scale (0-3) with scores ranging from 0 to 27, with higher scores reflecting greater depression severity. Scores above 10 are in the clinically depressed range. PHQ-9 has shown good psychometric properties., baseline, 1-week post-treatment|Difficulties with emotion regulation, To assess emotion regulation, the investigators will employ the Difficulties in Emotion Regulation Scale-Short Form, which comprises 18 items. These items gauge various aspects of emotion regulation, including one's ability to accept emotional responses, engage in purposeful actions, control impulses, be aware of emotions, access emotion regulation strategies, and attain emotional clarity. Each item is rated on a five-point Likert scale, with scores ranging from 1 to 5, resulting in total scores that fall between 18 and 90. Higher scores suggest greater problems with emotion regulation. This instrument has been rigorously tested and confirmed to be reliable in both adolescent and adult populations., baseline, 1-week post-treatment|Parent physical activity social support, Parent physical activity support will be measured via the Activity Support Scale for Multiple Groups (ACTS-MG) survey, which is a 12-item questionnaire that assesses parental support for exercise and consists of four subscales representing logistic support (e.g., I take my child to places where he/she can be active), modeling (e.g., I encourage my child to be physically active by leading by example), use of community resources (e.g., I encourage my child to use resources in our neighborhood to be active), and limiting sedentary activities (e.g., I limit how long my child plays video games). Items are scored on a 4-point Likert-type scale ranging from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating greater parental support for physical activity., baseline, 1-week post-treatment|Rating of perceived exertion, Perceived exertion during each exercise condition, the Ratings of Perceived Exertion (RPE) scale for children will be used (Borg 1998). At the completion of each exercise video, participants look to the RPE scale and answer the question, "How hard do you feel you are working?" Participants will respond by selecting a number on a 10-point scale that reflects their perceived exertion (1= "Very, very easy" to 10 = "So hard, I'm going to stop"). The RPE scale has been validated in children., during treatment