An interventional study of Physical activity in Adherence, Treatment and Physical Inactivity, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
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.
Experimental protocol: In Stage 1 of the intervention, 30 child participants will enroll in a home exercise program called InPACT at Home. The objective is for each participant to complete three 8-minute exercise videos per day, five days a week (30-45 minutes total daily). Participants will receive a calendar with links to the daily videos on a private YouTube channel. The response rate will be evaluated at the end of week 4, consistent with the original InPACT at Home pilot feasibility trial timeframe. Participants who do not complete Stage 1 will still be eligible to participate in Stage 2, focusing on adherence. Stage 2 involves ten participants continuing with InPACT at Home, while the remaining 20 will be randomly assigned to additional support groups. These groups include daily text message reminders (pings) for ten participants and personalized activity calendars based on individual physical activity preferences for the other ten. The response rate will again be assessed at the end of week 8. In Stage 3, seven participants initially assigned to InPACT at Home + Pings will be randomly reassigned to receive further support through either Tailoring (Condition A) or Coaching (Condition B). Similarly, seven participants initially assigned to InPACT at Home + Tailoring will be re-randomized to receive additional support via either Pings (Condition D) or Coaching (Condition E). Seven participants initially receiving no support will be re-randomized to receive either Pings (Condition G) or Tailoring (Condition H). The primary objective of this pilot project is to assess the feasibility of the study design, ensuring that the response rate does not influence randomization. The study duration is 60 days.
Intervention Components: The InPACT at Home intervention consists of a structured calendar of activities and high-quality exercise videos. Additional supports include personalization of the activity calendar to individual preferences, daily text message reminders to parents, and coaching sessions aimed at overcoming household barriers to participation. Previous research has validated the feasibility of InPACT at Home, while other studies support the effectiveness of the chosen support mechanisms.
Measurements: Consented participants will undergo pre- and post-intervention assessments including physical activity enjoyment, habitual physical activity levels, anxiety and depression symptoms, emotion regulation, and parent support for physical activity. These measures will inform a larger SMART study evaluating the impact of InPACT at Home on child social-emotional health.
Measurement Tools:
Measurements taken during the Experimental Conditions:
Feasibility will be determined by attrition rates and adherence to the intervention. Attrition will track participants who drop out, while dose will monitor those completing at least 40 of the 60 exercise videos. Video completion will be recorded on activity calendars signed off by parents, and view duration will be assessed using YouTube analytics. Objective physical activity data will be collected using FitBit monitors worn during activity breaks.
Statistical Considerations: Sample size for this pilot study is based on current budgetary constraints (n=30). Data from this study will generate pilot data to calculate effect sizes for a larger trial examining adherence and program effectiveness.
114 studies on the registry are indexed under Treatment Adherence and Compliance; 60 are open to participants now.
This study's enrollment of 46 is below the median of 84 across 97 interventional studies indexed under Treatment Adherence and Compliance.
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Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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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:
Exclusion Criteria:
Children will not be eligible for the study if they meet any of the following conditions:
Intervention is administered online (electronic calendars and text message pings) and virtually (coaching).
Behavioral: Physical activity
Intervention is administered online (electronic calendars and text message pings).
Behavioral: Physical activity
Intervention is administered online (electronic calendars and text message pings).
Behavioral: Physical activity
Intervention is administered online (electronic calendars and text message pings).
Behavioral: Physical activity
Intervention is administered online (electronic calendars) and virtually (coaching).
Behavioral: Physical activity
Intervention is administered online (electronic calendars).
Behavioral: Physical activity
Intervention is administered online (electronic calendars and text message pings).
Behavioral: Physical activity
Intervention is administered online (electronic calendars).
Behavioral: Physical activity
Intervention is administered online (electronic calendars).
Behavioral: Physical activity
Participants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks.
Dose of Exercise Received
Dose will be calculated as the average number of videos completed during the three-month intervention. Video duration was approximately 8 minutes. The self-reported average number of videos completed was recorded using activity calendar sheets.
Time frame: Assessed at 4 weeks, 8 weeks, and immediately post last treatment at 3 months; cumulative videos completed at 3 months reported.
Attrition
Attrition will be determined by calculating the total number of participants who drop out.
Time frame: Assessed at 4 weeks, 8 weeks, and immediately post last treatment at 3 months; cumulative drop out at 3 months reported.
Dose of Intervention Supports Received
Dose of intervention supports will be quantified as attendance at weekly coaching sessions (coaching), text messages (pings) an personalized calendars delivered throughout the intervention period. Research staff will document dose.
Time frame: Assessed at 8 weeks and immediately post last treatment at 3 months; cumulative intervention supports received at 3 months reported.
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.
Time frame: baseline, 1-week post-treatment; pre-post treatment change score reported.
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.
Time frame: baseline, 1-week post-treatment; pre-post treatment change score reported.
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.
Time frame: baseline, 1-week post-treatment; pre-post treatment change score reported.
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.
Time frame: baseline, 1-week post-treatment; pre-post treatment change score reported.
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.
Time frame: baseline, 1-week post-treatment; pre-post treatment change score reported.
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.
Time frame: baseline, 1-week post-treatment; pre-post treatment change score reported.
Families with children ages 8-12 years old were recruited to participate in this study through the University of Michigan Clinical Research website, newsletters, and from previous studies to participate in this at-home study.
| Milestone | Calendars + Pings + Coaching | Calendars + Pings + Tailored Calendar | Calendars + Pings + Pings | Calendar + Tailored Calendars + Pings | Calendar + Tailored Calendars + Coaching | Calendar + Tailored Calendars | Calendars + Pings | Calendars + Tailored Calendar | Calendars |
|---|---|---|---|---|---|---|---|---|---|
| Started | 4 | 6 | 5 | 5 | 6 | 9 | 3 | 4 | 4 |
| Completed | 3 | 5 | 4 | 2 | 5 | 6 | 2 | 4 | 4 |
| Not completed | 1 | 1 | 1 | 3 | 1 | 3 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 2 | 1 | 3 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 |
Dose will be calculated as the average number of videos completed during the three-month intervention. Video duration was approximately 8 minutes. The self-reported average number of videos completed was recorded using activity calendar sheets.
| cumulative videos completed | Calendars + Pings + Coaching | Calendars + Pings + Tailored Calendar | Calendars + Pings + Pings | Calendar + Tailored Calendars + Pings | Calendar + Tailored Calendars + Coaching | Calendar + Tailored Calendars | Calendars + Pings | Calendars + Tailored Calendar | Calendars |
|---|---|---|---|---|---|---|---|---|---|
| Dose of Exercise Received | 135.67 ± 60.58 | 145.20 ± 29.52 | 66.25 ± 38.78 | 116.50 ± 62.93 | 103.40 ± 58.86 | 174.50 ± 5.50 | 134.00 ± 45.25 | 85.25 ± 43.16 | 62.00 ± 41.79 |
Attrition will be determined by calculating the total number of participants who drop out.
Results for this outcome have not been posted.
Dose of intervention supports will be quantified as attendance at weekly coaching sessions (coaching), text messages (pings) an personalized calendars delivered throughout the intervention period. Research staff will document dose.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 10 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Calendars + Pings + Coaching | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Calendars + Pings + Tailored Calendar | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Calendars + Pings + Pings | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Calendar + Tailored Calendars + Pings | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Calendar + Tailored Calendars + Coaching | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Calendar + Tailored Calendars | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Calendars + Pings | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Calendars + Tailored Calendar | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Calendars | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Calendars + Pings + Coaching | Calendars + Pings + Tailored Calendar | Calendars + Pings + Pings | Calendar + Tailored Calendars + Pings | Calendar + Tailored Calendars + Coaching | Calendar + Tailored Calendars | Calendars + Pings | Calendars + Tailored Calendar | Calendars | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 4 | 6 | 5 | 5 | 6 | 9 | 3 | 4 | 4 | 46 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Calendars + Pings + Coaching | Calendars + Pings + Tailored Calendar | Calendars + Pings + Pings | Calendar + Tailored Calendars + Pings | Calendar + Tailored Calendars + Coaching | Calendar + Tailored Calendars | Calendars + Pings | Calendars + Tailored Calendar | Calendars | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 10.97 ± 0.55 | 11.39 ± 0.85 | 10.76 ± 1.46 | 9.60 ± 1.12 | 9.87 ± 1.31 | 9.76 ± 1.67 | 10.9 ± 0.07 | 11.08 ± 1.07 | 9.95 ± 2.08 | 10.39 ± 1.38 |
| Sex: Female, Male(Participants) | Calendars + Pings + Coaching | Calendars + Pings + Tailored Calendar | Calendars + Pings + Pings | Calendar + Tailored Calendars + Pings | Calendar + Tailored Calendars + Coaching | Calendar + Tailored Calendars | Calendars + Pings | Calendars + Tailored Calendar | Calendars | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 1 | 3 | 2 | 3 | 3 | 3 | 2 | 3 | 2 | 22 |
| Male | 3 | 3 | 3 | 2 | 3 | 6 | 1 | 1 | 2 | 24 |
| Ethnicity (NIH/OMB)(Participants) | Calendars + Pings + Coaching | Calendars + Pings + Tailored Calendar | Calendars + Pings + Pings | Calendar + Tailored Calendars + Pings | Calendar + Tailored Calendars + Coaching | Calendar + Tailored Calendars | Calendars + Pings | Calendars + Tailored Calendar | Calendars | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 6 | 5 | 4 | 4 | 9 | 2 | 4 | 4 | 42 |
| Not Hispanic or Latino | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Calendars + Pings + Coaching | Calendars + Pings + Tailored Calendar | Calendars + Pings + Pings | Calendar + Tailored Calendars + Pings | Calendar + Tailored Calendars + Coaching | Calendar + Tailored Calendars | Calendars + Pings | Calendars + Tailored Calendar | Calendars | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 2 | 0 | 3 | 2 | 1 | 1 | 1 | 11 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 3 |
| White | 4 | 4 | 2 | 3 | 2 | 7 | 2 | 2 | 2 | 28 |
| More than one race | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Calendars + Pings + Coaching | Calendars + Pings + Tailored Calendar | Calendars + Pings + Pings | Calendar + Tailored Calendars + Pings | Calendar + Tailored Calendars + Coaching | Calendar + Tailored Calendars | Calendars + Pings | Calendars + Tailored Calendar | Calendars | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| United States | 4 | 6 | 5 | 5 | 6 | 9 | 3 | 4 | 4 | 46 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — For the proposed research, the investigators will enroll 30 children. The investigators will be collecting physical activity and questionnaire data from these participants. All data will be de-identified. The investigators do not anticipate sharing data or samples with other investigators, but the investigators will make data available for sharing with other researchers if they sign a data sharing agreement indicating that: 1. They will use the data for research purposes only. 2. All data will be retained on a secure/password protected computer and computer program. 3. If the identity of any participant is compromised, they will inform us immediately. 4. Commitment to destroy or return the data after their analysis is complete
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Treatment Adherence and Compliance→
University of Michigan