Department of Biobehavioral Health and Nursing Science, College of Nursing, University of South Carolina, 1601 Greene Street, Columbia, SC, 29201, USA.
Department of Psychology, University of South Carolina, Columbia, SC, 29201, USA.
Int J Behav Nutr Phys Act. 2024 Aug 13;21(1):88. doi: 10.1186/s12966-024-01635-1.
This study demonstrates how formative process evaluation was used to assess implementation and improve dose and fidelity in the Together Everyone Achieves More Physical Activity (TEAM-PA) randomized controlled trial. TEAM-PA uses a randomized group cohort design to evaluate the efficacy of a group-based intervention for increasing physical activity among African American women.
Intervention groups met for 10 weeks and were co-led by female African American facilitators, with intervention sessions consisting of group feedback, a health curriculum, group-based physical activity games, and group-based goal-setting. Drawing from a multi-theoretical framework, the intervention targeted social affiliation using collaborative and competitive group strategies, including essential elements focused on group-based behavioral skills, peer-to-peer positive communication, collectivism, optimal challenge, social facilitation, and peer to peer challenges. Formative process evaluation was used to monitor reach, dose, and fidelity, and implement feedback and solutions.
Across two cohorts, four groups (n = 54) were randomized to the TEAM-PA intervention. On average 84.8% of participants attended each week, which exceeded the a priori criteria. Results from the systematic observations indicated that on average 93% of the dose items were completed in each session and adequate levels of fidelity were achieved at both the facilitator and group-levels. Participants were compliant with wearing the FitBits (6.73 ± 0.42 days/week) and most participants successfully contributed to meeting the group-based goals. The use of open-ended items also revealed the need for additional modifications to the group-based PA games, including allowing for individuals to take breaks, incorporating a broader range of exercises, minimizing activities that required bending/reaching down without assistance, and providing facilitators with additional training for implementing the games. Initial evidence suggests that these changes were successful in increasing participants' comprehension of the games from Cohort 1 (M = 1.83, SD = 0.71) to Cohort 2 (M = 3.33, SD = 0.69).
Findings from this study demonstrated high levels of reach, dose, and fidelity, while also highlighting strategies for implementing competitive group-based PA games that are accessible across physical fitness levels. Formative process evaluation, including open-ended items and collaborative brainstorming, holds tremendous potential for improving future interventions.
This study was registered on Clinicaltrials.gov (# NCT05519696) on August 22, 2022 prior to the enrollment of the first participant on September 12, 2022 ( https://clinicaltrials.gov/study/NCT05519696?term=NCT05519696&rank=1 ).
本研究展示了形成性过程评估如何用于评估实施情况并提高在“一起实现更多体育活动（TEAM-PA）”随机对照试验中的剂量和保真度。TEAM-PA 使用随机分组队列设计来评估针对非裔美国女性增加体育活动的基于小组的干预措施的效果。
干预组会面 10 周，由非裔美国女性主持人共同领导，干预会议包括小组反馈、健康课程、基于小组的体育活动游戏和基于小组的目标设定。该干预措施借鉴了多理论框架，通过协作和竞争小组策略来针对社交联系，包括侧重于基于小组的行为技能、同伴间积极沟通、集体主义、最佳挑战、社会促进和同伴间挑战的核心要素。形成性过程评估用于监测范围、剂量和保真度，并实施反馈和解决方案。
在两个队列中，四组（n=54）被随机分配到 TEAM-PA 干预组。平均而言，84.8%的参与者每周参加一次，超过了事先设定的标准。系统观察结果表明，每个会议平均完成了 93%的剂量项目，并且在主持人和小组层面都达到了足够的保真度水平。参与者遵守佩戴 FitBit（每周 6.73±0.42 天）的规定，并且大多数参与者成功地为达到小组目标做出了贡献。使用开放式项目还揭示了需要对基于小组的 PA 游戏进行额外修改，包括允许个人休息、纳入更广泛的锻炼范围、最大限度地减少需要帮助才能弯腰/伸手的活动，以及为主持人提供实施游戏的额外培训。初步证据表明，这些更改成功地提高了参与者对第 1 队列（M=1.83，SD=0.71）和第 2 队列（M=3.33，SD=0.69）中游戏的理解。
这项研究的结果表明，实现了高的可达性、剂量和保真度，同时还强调了实施具有竞争力的基于小组的 PA 游戏的策略，这些策略在不同的体能水平下都具有可及性。形成性过程评估，包括开放式项目和协作头脑风暴，为改进未来的干预措施提供了巨大的潜力。
本研究于 2022 年 8 月 22 日在 Clinicaltrials.gov 上注册（#NCT05519696），并于 2022 年 9 月 12 日首次招募参与者之前进行了注册（https://clinicaltrials.gov/study/NCT05519696?term=NCT05519696&rank=1）。
