Interrupting Prolonged Sitting With ACTivity (InPACT) at Home Optimization Study
Utilizing a SMART Intervention Design to Optimize Participant Adherence in Home-based Behavioral Interventions
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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:
- Have access to a computer and internet at home.
- Be proficient in English.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Calendars + Pings + Coaching
Intervention is administered online (electronic calendars and text message pings) and virtually (coaching).
|
Participants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks.
|
|
Experimental: Calendars + Pings + Tailored Calendar
Intervention is administered online (electronic calendars and text message pings).
|
Participants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks.
|
|
Experimental: Calendars + Pings + Pings
Intervention is administered online (electronic calendars and text message pings).
|
Participants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks.
|
|
Experimental: Calendar + Tailored calendars + Pings
Intervention is administered online (electronic calendars and text message pings).
|
Participants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks.
|
|
Experimental: Calendar + Tailored calendars + Coaching
Intervention is administered online (electronic calendars) and virtually (coaching).
|
Participants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks.
|
|
Experimental: Calendar + Tailored calendars
Intervention is administered online (electronic calendars).
|
Participants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks.
|
|
Experimental: Calendars + Pings
Intervention is administered online (electronic calendars and text message pings).
|
Participants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks.
|
|
Experimental: Calendars + Tailored calendar
Intervention is administered online (electronic calendars).
|
Participants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks.
|
|
Experimental: Calendars
Intervention is administered online (electronic calendars).
|
Participants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Assessed at 4 weeks, 8 weeks, and immediately post last treatment at 3 months; cumulative videos completed at 3 months reported.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attrition
Time Frame: Assessed at 4 weeks, 8 weeks, and immediately post last treatment at 3 months; cumulative drop out at 3 months reported.
|
Attrition will be determined by calculating the total number of participants who drop out.
|
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.
|
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.
|
Assessed at 8 weeks and immediately post last treatment at 3 months; cumulative intervention supports received at 3 months reported.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity Enjoyment Scale
Time Frame: baseline, 1-week post-treatment; pre-post treatment change score reported.
|
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; pre-post treatment change score reported.
|
|
Physical Activity Questionnaire for Children
Time Frame: baseline, 1-week post-treatment; pre-post treatment change score reported.
|
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; pre-post treatment change score reported.
|
|
Anxiety Symptoms
Time Frame: baseline, 1-week post-treatment; pre-post treatment change score reported.
|
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; pre-post treatment change score reported.
|
|
Depression Symptoms
Time Frame: baseline, 1-week post-treatment; pre-post treatment change score reported.
|
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; pre-post treatment change score reported.
|
|
Difficulties With Emotion Regulation
Time Frame: baseline, 1-week post-treatment; pre-post treatment change score reported.
|
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; pre-post treatment change score reported.
|
|
Parent Physical Activity Social Support
Time Frame: baseline, 1-week post-treatment; pre-post treatment change score reported.
|
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; pre-post treatment change score reported.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rebecca E Hasson, PhD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00253411
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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:
- They will use the data for research purposes only.
- All data will be retained on a secure/password protected computer and computer program.
- If the identity of any participant is compromised, they will inform us immediately.
- Commitment to destroy or return the data after their analysis is complete
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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