Utilizing a SMART Intervention Design to Optimize Participant Adherence in Home-based Behavioral Interventions

University of Michigan2 个研究点分布在 1 个国家目标入组 46 人开始时间: 2024年8月20日最近更新: 2026年7月13日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Michigan
入组人数: 46
试验地点: 2
主要终点: Dose of exercise received

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Prevention
盲法: None

入排标准

年龄范围: 8 Years 至 12 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.