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临床试验/NCT05981508
NCT05981508已完成不适用

Feasibility of Conducting an Online Family Dyadic/Couple Skills Training for Black Adults Enrolled in a Behavioral Weight Loss Intervention - Together, Eating and Activity, Matter+ (TEAM+)

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Change in Body Weight

研究概览

简要总结

The purpose of this research study is to test the feasibility and acceptability of an interactive counselor -led online family skills training as part of a behavioral weight loss program for Black Adults.

详细描述

Nearly half (49.9%) of Black adults in the United States live with obesity. Black adults are underrepresented in standard behavioral weight loss (BWL) interventions and experience sub-optimal weight loss outcomes when included in such programs. Cultural adaptations to BWL interventions that recognize the family behavioral context and address the cultural value of family among Black populations are needed to improve weight loss outcomes. Prior research, including our randomized controlled pilot, Together, Eating and Activity, Matter Plus (TEAM+), have incorporated family skills training to enhance family involvement, targeting cohesion and communication, in addition to core weight loss curriculum. However, family inclusion in weight loss interventions can result in additional barriers to retention and adherence.

Technology has become an attractive delivery format to increase reach to at-risk populations, as a well-designed online program can address issues of timely access and geographical location (or distance from program sites), which are linked to low retention of Black participants. However, technology uptake among Blacks populations still lags due to mistrust, skepticism, concerns about confidentiality, privacy, and remote interaction with staff. Increases in acceptance and utilization of telemedicine and mobile-health were reported during the COVID-19 pandemic. Considering the time and location burden already associated with behavioral weight loss sessions, it is important to identify strategies to increase access that are both feasible and acceptable in the target population. Currently the feasibility and acceptability of an online family dyadic skills training is unknown among Black adults.

TEAM+ is an in-person 3-month family enhanced BWL intervention designed for Black adults consisting of a family dyadic skills training and core behavioral weight loss sessions. For this proposed pilot study, 20 black adults interested in weight loss will be recruited with a family member committed to attending both the skills training and core sessions. Participants must 1) be ≥18 years of age, 2) self-identify as Black/African American, 3) reside in the Raleigh/Durham/Chapel Hill area, and 4) have internet access. The core sessions will be delivered in person. To test the feasibility and acceptability of an interactive counselor-led online training, the family dyadic skills training will be delivered online using a web-conferencing platform (e.g., Zoom).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • self-identify as a Black or African American,
  • are between 18-75 years old
  • have a family member willing to attend study session with you
  • have Internet access
  • reside in the Raleigh/Durham/Chapel Hill area,

排除标准

  • not interested in losing weight
  • have any conditions affecting weight
  • currently receiving cancer treatment

结局指标

主要结局

Change in Body Weight

时间窗: Baseline, 12 weeks

Body weight (kg) expressed as a continuous variable will be collected on a digital scale.

次要结局

  • Change in Self-Efficacy of Eating Behaviors(Baseline,12 weeks)
  • Change in Social Support Effectiveness(Baseline,12 weeks)
  • Change in Social Support for Eating(Baseline,12 weeks)
  • Change in Social Support for Exercise(Baseline,12 weeks)
  • Change in Family Communication(Baseline, 12 weeks)
  • Change in Family Perceived Criticism(Baseline, 12 weeks)
  • Change in Family Cohesion(Baseline, 12 weeks)
  • Change in Family Emotional Involvement(Baseline, 12 weeks)
  • Change in Body Mass Index (BMI)(Baseline,12 weeks)
  • Change in Self-Regulation of Eating Behaviors(Baseline,12 weeks)
  • Change in Body Mass Index (BMI)(Baseline,12 weeks)
  • Change in Self-Regulation of Eating Behaviors(Baseline,12 weeks)
  • Change in Self-Efficacy of Eating Behaviors(Baseline,12 weeks)
  • Change in Social Support Effectiveness(Baseline,12 weeks)
  • Change in Social Support for Eating(Baseline,12 weeks)
  • Change in Social Support for Exercise(Baseline,12 weeks)
  • Change in Family Communication(Baseline, 12 weeks)
  • Change in Family Cohesion(Baseline, 12 weeks)
  • Change in Family Emotional Involvement(Baseline, 12 weeks)
  • Change in Family Perceived Criticism(Baseline, 12 weeks)
  • Change in Family Collaborative Problem Solving(Baseline, 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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