Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493214
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Interrupting Prolonged Sitting With ACTivity InPACT at Home Optimization Study
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Utilizing a SMART Intervention Design to Optimize Participant Adherence in Home-based Behavioral Interventions
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 n30 Data from this study will generate pilot data to calculate effect sizes for a larger trial examining adherence and program effectiveness
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 n30 Data from this study will generate pilot data to calculate effect sizes for a larger trial examining adherence and program effectiveness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None