Adherence, TreatmentNCT06493214
Interrupting Prolonged Sitting With ACTivity (InPACT) at Home Optimization Study
A study testing Physical activity in people with Adherence, Treatment and Physical Inactivity, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Adherence, Treatment, Physical Inactivity
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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:
- Have access to a computer and internet at home.
- Be proficient in English.
Who cannot join
- Children will not be eligible for the study if they meet any of the following conditions:
- Currently taking medications (e.g., iron, metformin, chemotherapeutic agents) that could impact their ability to engage in physical activity.
- Previously diagnosed with conditions that could impact their ability to engage in physical exercise (e.g., uncontrolled asthma).
- 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.
- Diagnosed with a physical or mental disability that would make it difficult to answer questions or follow directions without the help of an adult.
- 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.
- Potential participants who are ineligible will be told so on their screening call and will not be enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilizing a SMART Intervention Design to Optimize Participant Adherence in Home-based Behavioral Interventions
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.
Read the detailed description
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:
- Physical Activity Enjoyment Scale: A validated questionnaire assessing enjoyment during physical activity.
- Physical Activity Questionnaire for Children (PAQ-C): Assesses pre- and post-intervention physical activity levels.
- Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7): Measure depression and anxiety symptoms, respectively.
- Difficulties in Emotion Regulation Scale-Short Form: Evaluates emotion regulation abilities.
- Parental Support of Physical Activity Questionnaire: Assesses parental support for child physical activity.
- Ratings of Perceived Exertion Scale: Measures perceived exertion during exercise sessions using a 10-point scale.
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.
- Conditions
- Adherence, Treatment, Physical Inactivity
- Being tested
- Physical activity
- Medical subject headings
- Treatment Adherence and Compliance, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Participants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Calendars + Pings + Coaching | Experimental | Intervention is administered online (electronic calendars and text message pings) and virtually (coaching). Receives: Behavioral: Physical activity |
| Calendars + Pings + Tailored Calendar | Experimental | Intervention is administered online (electronic calendars and text message pings). Receives: Behavioral: Physical activity |
| Calendars + Pings + Pings | Experimental | Intervention is administered online (electronic calendars and text message pings). Receives: Behavioral: Physical activity |
| Calendar + Tailored calendars + Pings | Experimental | Intervention is administered online (electronic calendars and text message pings). Receives: Behavioral: Physical activity |
| Calendar + Tailored calendars + Coaching | Experimental | Intervention is administered online (electronic calendars) and virtually (coaching). Receives: Behavioral: Physical activity |
| Calendar + Tailored calendars | Experimental | Intervention is administered online (electronic calendars). Receives: Behavioral: Physical activity |
| Calendars + Pings | Experimental | Intervention is administered online (electronic calendars and text message pings). Receives: Behavioral: Physical activity |
| Calendars + Tailored calendar | Experimental | Intervention is administered online (electronic calendars). Receives: Behavioral: Physical activity |
| Calendars | Experimental | Intervention is administered online (electronic calendars). Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at 4 weeks, 8 weeks, and immediately post last treatment at 3 months; cumulative videos completed at 3 months reported.
Secondary outcomes (2)
Attrition
Attrition will be determined by calculating the total number of participants who drop out.
Measured: 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.
Measured: Assessed at 8 weeks and immediately post last treatment at 3 months; cumulative intervention supports received at 3 months reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start20 Aug 2024
- Primary completion12 May 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adherence, TreatmentStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- In Stage 1 of the intervention, 30 child participants will enroll in the InPACT at Home exercise program, aiming to complete three 8-minute videos per day, five days a week. After four weeks, response rates will be evaluated. In Stage 2, ten participants will continue the program, while the other 20 will receive additional support via daily text messages or personalized activity calendars. In Stage 3, participants will be re-randomized to receive further support through either Tailoring or Coaching, with feasibility and response rates assessed throughout the 60-day study.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Hasson, University of Michigan
- Investigators
- Rebecca E Hasson, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493214
- Sponsor's protocol ID
- HUM00253411
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2024
- Last updated
- 13 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing a SMART Intervention Design to Optimize Participant Adherence in Home-based Behavioral Interventions
- ClinicalTrials.gov ID
- NCT06493214
- Acronym / sponsor ID
- HUM00253411
- Conditions
- Adherence, Treatment, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Posted 13 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Physical Activity Enjoyment Scale: A validated questionnaire assessing enjoyment during physical activity.
- Physical Activity Questionnaire for Children (PAQ-C): Assesses pre- and post-intervention physical activity levels.
- Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7): Measure depression and anxiety symptoms, respectively.
- Difficulties in Emotion Regulation Scale-Short Form: Evaluates emotion regulation abilities.
- Parental Support of Physical Activity Questionnaire: Assesses parental support for child physical activity.
- Ratings of Perceived Exertion Scale: Measures perceived exertion during exercise sessions using a 10-point scale.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- In Stage 1 of the intervention, 30 child participants will enroll in the InPACT at Home exercise program, aiming to complete three 8-minute videos per day, five days a week. After four weeks, response rates will be evaluated. In Stage 2, ten participants will continue the program, while the other 20 will receive additional support via daily text messages or personalized activity calendars. In Stage 3, participants will be re-randomized to receive further support through either Tailoring or Coaching, with feasibility and response rates assessed throughout the 60-day study.
| Arm | Type | Receives |
|---|---|---|
| Calendars + Pings + Coaching | Experimental | Behavioral: Physical activityIntervention is administered online (electronic calendars and text message pings) and virtually (coaching). |
| Calendars + Pings + Tailored Calendar | Experimental | Behavioral: Physical activityIntervention is administered online (electronic calendars and text message pings). |
| Calendars + Pings + Pings | Experimental | Behavioral: Physical activityIntervention is administered online (electronic calendars and text message pings). |
| Calendar + Tailored calendars + Pings | Experimental | Behavioral: Physical activityIntervention is administered online (electronic calendars and text message pings). |
| Calendar + Tailored calendars + Coaching | Experimental | Behavioral: Physical activityIntervention is administered online (electronic calendars) and virtually (coaching). |
| Calendar + Tailored calendars | Experimental | Behavioral: Physical activityIntervention is administered online (electronic calendars). |
| Calendars + Pings | Experimental | Behavioral: Physical activityIntervention is administered online (electronic calendars and text message pings). |
| Calendars + Tailored calendar | Experimental | Behavioral: Physical activityIntervention is administered online (electronic calendars). |
| Calendars | Experimental | Behavioral: Physical activityIntervention is administered online (electronic calendars). |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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:
- Have access to a computer and internet at home.
- Be proficient in English.
Key exclusion criteria (7 listed)
- Currently taking medications (e.g., iron, metformin, chemotherapeutic agents) that could impact their ability to engage in physical activity.
- Previously diagnosed with conditions that could impact their ability to engage in physical exercise (e.g., uncontrolled asthma).
- 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.
- Diagnosed with a physical or mental disability that would make it difficult to answer questions or follow directions without the help of an adult.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityParticipants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks. | Behavioural | Calendar + Tailored calendars, Calendar + Tailored calendars + Coaching, Calendar + Tailored calendars + Pings, Calendars, Calendars + Pings, Calendars + Pings + Coaching, Calendars + Pings + Pings, Calendars + Pings + Tailored Calendar, Calendars + Tailored calendar |
Primary outcome
Dose of Exercise Received
Time frame: Assessed at 4 weeks, 8 weeks, and immediately post last treatment at 3 months; cumulative videos completed at 3 months reported.
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.
2 secondary outcomes
Attrition
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
Time frame: Assessed at 8 weeks and immediately post last treatment at 3 months; cumulative intervention supports received at 3 months reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca E Hasson, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Adherence, Treatment and Physical Inactivity, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of Exercise Received (time frame: Assessed at 4 weeks, 8 weeks, and immediately post last treatment at 3 months; cumulative videos completed at 3 months reported.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.