Interrupting Prolonged Sitting With ACTivity (InPACT) at Home Optimization Study

NCT06493214 | Completed

• 1 other identifier: HUM00253411
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Treatment; Physical Inactivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Attrition

  Mid-treatment (4 and 8 weeks), immediately post-treatment

• Dose of intervention supports received

  Mid-treatment (4 and 8 weeks), immediately post-treatment

Other Outcomes (7)

• Physical activity enjoyment scale

  baseline, 1-week post-treatment

• Physical activity questionnaire for children

  baseline, 1-week post-treatment

• Anxiety symptoms

  baseline, 1-week post-treatment

Study Arms (9)

Calendars + Pings + Coaching

EXPERIMENTAL

Intervention is administered online (electronic calendars and text message pings) and virtually (coaching).

Behavioral: Physical activity

Calendars + Pings + Tailored Calendar

EXPERIMENTAL

Intervention is administered online (electronic calendars and text message pings).

Behavioral: Physical activity

Calendars + Pings + Pings

EXPERIMENTAL

Intervention is administered online (electronic calendars and text message pings).

Behavioral: Physical activity

Calendar + Tailored calendars + Pings

EXPERIMENTAL

Intervention is administered online (electronic calendars and text message pings).

Behavioral: Physical activity

Calendar + Tailored calendars + Coaching

EXPERIMENTAL

Intervention is administered online (electronic calendars) and virtually (coaching).

Behavioral: Physical activity

Calendar + Tailored calendars

EXPERIMENTAL

Intervention is administered online (electronic calendars).

Behavioral: Physical activity

Calendars + Pings

EXPERIMENTAL

Intervention is administered online (electronic calendars and text message pings).

Behavioral: Physical activity

Calendars + Tailored calendar

EXPERIMENTAL

Intervention is administered online (electronic calendars).

Behavioral: Physical activity

Calendars

EXPERIMENTAL

Intervention is administered online (electronic calendars).

Behavioral: Physical activity

Interventions

Physical activity BEHAVIORAL

Participants will be asked to complete three eight-minute InPACT at Home exercise videos per day, five days a week, for 12 weeks.

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

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance; Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rebecca E Hasson, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: August 20, 2024
• Primary Completion: May 12, 2025
• Study Completion: July 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)