FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing): Optimization and Evaluation Using Multiphase Optimization Strategy (MOST) and Social Network Analysis (SNA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Change in Body weight
研究概览
简要总结
The goal of this clinical trial is to learn the best combination of family components that yields optimal weight loss among Black adults. The main question it aims to answer is:
What combination of four family components in combination with a standard behavioral weight loss program yields optimal weight loss among Black adults? Researchers will compare different combinations of family skills components (communication content, cohesion content, number of sessions, and mode of delivery) to see the best weight loss.
Participants will:
- Participate in a 6-month behavioral weight loss intervention
- Attend core weight loss in-person group sessions, and dyad based family sessions
- Keep track of weight, dietary intake and physical activity
详细描述
This clinical trial aims to determine the most effective combination of family components to achieve optimal weight loss among Black adults. The main focus is to assess how different combinations of four family skills components-communication content, cohesion content, number of sessions, and mode of delivery-work together with a standard behavioral weight loss program.
Participants will engage in a 6-month behavioral weight loss intervention, which includes attending group weight loss sessions and family-based dyad sessions. They will also track their weight, dietary intake, and physical activity.
This is a 2 x4 factorial design with 16 study conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- 否
入选标准
- •self-identified as Black or African American (Index participant)
- •BMI equal to greater than 30 kg/m^2 (Index); BMI equal to greater than 27.5 kg/m^2 (family partner)
- •have a partner/family member willing to enroll in the study and must share a mutual goal of achieving weight loss
- •English speaking
- •ages 18-75
- •any gender
- •have access to and be able to use a smartphone, tablet, or computer that has web-access (this is required for data collection and some program components being tested)
排除标准
- •participation in an intensive weight loss program (more than 12 visits) in the prior 6 months
- •type 1 diabetes
- •significant psychiatric illness, defined as depression or other major psychiatric illness not considered reasonably managed by counseling, medication, or both
- •had bariatric surgery (surgery for weight loss) in the last 2 years or considering bariatric surgery in the next 6 months
- •using or planning to start medications intentionally for weight loss
- •are pregnant or planning to get pregnant in the next 6 months
- •are breastfeeding and less than 2 months postpartum
- •alcohol or substance abuse, defined as alcohol or substance use that interferes with work activities and/or has had a major negative impact on family/social function, the latter defined as more than 2 episodes per month.
- •malignancy other than non-melanoma skin cancer, unless considered cured > 5 years ago. Exceptions include 1) men with localized prostate cancer (treated with usual modalities or managed with "active surveillance"), and 2) postmenopausal women receiving adjuvant endocrine therapy (e.g., aromatase inhibitor) for non-metastatic, hormone receptor-positive breast cancer
- •self-report of advanced kidney disease (estimated glomerular filtration rate (GFR) < 30 mL/min)
研究组 & 干预措施
Session 5, In-Person, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion
干预措施: Family Skills Training Content: Communication (Behavioral)
Session 5, In-Person, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion
干预措施: Family Skills Training Content: No Cohesion (Behavioral)
Session 5, In-Person, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering cohesion but no communication
干预措施: Family Skills Training Session Quantity: 5 (Behavioral)
Session 5, On-Line, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion
干预措施: Family Skills Training Session Mode: Online (Behavioral)
Session 5, On-Line, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion
干预措施: Family Skills Training Session Quantity: 5 (Behavioral)
Session 5, On-Line, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion
干预措施: Family Skills Training Content: Communication (Behavioral)
Session 5, On-Line, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion
干预措施: Family Skills Training Session Mode: Online (Behavioral)
Session 10, In-Person, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion
干预措施: Family Skills Training Content: Cohesion (Behavioral)
Session 10, In-Person, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering cohesion but no no communication
干预措施: Family Skills Training Content: Cohesion (Behavioral)
Session 10, In-Person, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering cohesion but no no communication
干预措施: Family Skills Training Session Quantity: 10 (Behavioral)
Session 10, In-Person, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering cohesion but no no communication
干预措施: Family Skills Training Content: No Communication (Behavioral)
Session 5, In-Person, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion
干预措施: Family Skills Training Session Quantity: 5 (Behavioral)
Session 5, In-Person, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion
干预措施: Family Skills Training Session Mode: In-person (Behavioral)
Session 5, In-Person, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion
干预措施: Family Skills Training Content: Communication (Behavioral)
Session 5, In-Person, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication and cohesion
干预措施: Family Skills Training Content: Cohesion (Behavioral)
Session 5, In-Person, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion
干预措施: Family Skills Training Session Quantity: 5 (Behavioral)
Session 5, In-Person, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering communication but no cohesion
干预措施: Family Skills Training Session Mode: In-person (Behavioral)
Session 5, In-Person, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering cohesion but no communication
干预措施: Family Skills Training Session Mode: In-person (Behavioral)
Session 5, In-Person, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering cohesion but no communication
干预措施: Family Skills Training Content: Cohesion (Behavioral)
Session 5, In-Person, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering no communication but no cohesion
干预措施: Family Skills Training Session Quantity: 5 (Behavioral)
Session 5, In-Person, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering no communication but no cohesion
干预措施: Family Skills Training Session Mode: In-person (Behavioral)
Session 5, In-Person, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering no communication but no cohesion
干预措施: Family Skills Training Content: Communication (Behavioral)
Session 5, In-Person, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering no communication but no cohesion
干预措施: Family Skills Training Content: Cohesion (Behavioral)
Session 5, In-Person, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions in-person with content covering no communication but no cohesion
干预措施: Family Skills Training Content: No Communication (Behavioral)
Session 5, On-Line, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion
干预措施: Family Skills Training Session Quantity: 5 (Behavioral)
Session 5, On-Line, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion
干预措施: Family Skills Training Content: Communication (Behavioral)
Session 5, On-Line, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication and cohesion
干预措施: Family Skills Training Content: Cohesion (Behavioral)
Session 5, On-Line, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication
干预措施: Family Skills Training Session Mode: Online (Behavioral)
Session 5, On-Line, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering communication but no cohesion
干预措施: Family Skills Training Content: No Cohesion (Behavioral)
Session 5, On-Line, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication
干预措施: Family Skills Training Session Quantity: 5 (Behavioral)
Session 5, On-Line, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication
干预措施: Family Skills Training Content: Cohesion (Behavioral)
Session 5, On-Line, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering cohesion but no communication
干预措施: Family Skills Training Content: No Communication (Behavioral)
Session 5, On-Line, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering no communication and no cohesion
干预措施: Family Skills Training Session Quantity: 5 (Behavioral)
Session 5, On-Line, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering no communication and no cohesion
干预措施: Family Skills Training Session Mode: Online (Behavioral)
Session 5, On-Line, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering no communication and no cohesion
干预措施: Family Skills Training Content: No Communication (Behavioral)
Session 5, On-Line, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 5 family skills training sessions on-line with content covering no communication and no cohesion
干预措施: Family Skills Training Content: No Cohesion (Behavioral)
Session 10, In-Person, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion
干预措施: Family Skills Training Session Mode: In-person (Behavioral)
Session 10, In-Person, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion
干预措施: Family Skills Training Content: Communication (Behavioral)
Session 10, In-Person, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication and cohesion
干预措施: Family Skills Training Session Quantity: 10 (Behavioral)
Session 10, In-Person, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion
干预措施: Family Skills Training Session Mode: In-person (Behavioral)
Session 10, In-Person, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion
干预措施: Family Skills Training Content: Communication (Behavioral)
Session 10, In-Person, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion
干预措施: Family Skills Training Session Quantity: 10 (Behavioral)
Session 10, In-Person, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering communication but no cohesion
干预措施: Family Skills Training Content: No Cohesion (Behavioral)
Session 10, In-Person, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering cohesion but no no communication
干预措施: Family Skills Training Session Mode: In-person (Behavioral)
Session 10, In-Person, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering no communication and no cohesion
干预措施: Family Skills Training Session Mode: In-person (Behavioral)
Session 10, In-Person, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering no communication and no cohesion
干预措施: Family Skills Training Session Quantity: 10 (Behavioral)
Session 10, In-Person, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering no communication and no cohesion
干预措施: Family Skills Training Content: No Communication (Behavioral)
Session 10, In-Person, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions in-person with content covering no communication and no cohesion
干预措施: Family Skills Training Content: No Cohesion (Behavioral)
Session 10, On-Line, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion
干预措施: Family Skills Training Content: Communication (Behavioral)
Session 10, On-Line, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion
干预措施: Family Skills Training Content: Cohesion (Behavioral)
Session 10, On-Line, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion
干预措施: Family Skills Training Session Quantity: 10 (Behavioral)
Session 10, On-Line, Communication and Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication and cohesion
干预措施: Family Skills Training Session Mode: Online (Behavioral)
Session 10, On-Line, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion
干预措施: Family Skills Training Content: Communication (Behavioral)
Session 10, On-Line, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion
干预措施: Family Skills Training Session Quantity: 10 (Behavioral)
Session 10, On-Line, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion
干预措施: Family Skills Training Session Mode: Online (Behavioral)
Session 10, On-Line, Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering communication but no cohesion
干预措施: Family Skills Training Content: No Cohesion (Behavioral)
Session 10, On-Line, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication
干预措施: Family Skills Training Content: Cohesion (Behavioral)
Session 10, On-Line, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication
干预措施: Family Skills Training Session Quantity: 10 (Behavioral)
Session 10, On-Line, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication
干预措施: Family Skills Training Session Mode: Online (Behavioral)
Session 10, On-Line, Cohesion and No Communication
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering cohesion but no communication
干预措施: Family Skills Training Content: No Communication (Behavioral)
Session 10, On-Line, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering no communication and no cohesion
干预措施: Family Skills Training Session Quantity: 10 (Behavioral)
Session 10, On-Line, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering no communication and no cohesion
干预措施: Family Skills Training Session Mode: Online (Behavioral)
Session 10, On-Line, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering no communication and no cohesion
干预措施: Family Skills Training Content: No Communication (Behavioral)
Session 10, On-Line, No Communication and No Cohesion
Participants will receive core behavioral weight loss group sessions and 10 family skills training sessions on-line with content covering no communication and no cohesion
干预措施: Family Skills Training Content: No Cohesion (Behavioral)
结局指标
主要结局
Change in Body weight
时间窗: baseline and 6 months
Body weight (kg) expressed as a continuous variable will be collected on a digital scale.
次要结局
- Mean Change in Blood Pressure(baseline and 6 months)
- Change in skin carotenoids(baseline and 6 months)
- Change in physical activity steps(baseline and 6 months)
- Change in glycosylated hemoglobin (A1c)(baseline and 6 months)
- Current Subjective Social Status(baseline)
- Change in Quality of Life(baseline and 6 months)
- Change in Depression(baseline and 6 months)
- Change in Perceived stress(baseline and 6 months)
- Change for social support for exercise(baseline and 6 months)
- Change in Self-Efficacy of Eating Behaviors(baseline and 6 months)
- Change in Self-Efficacy of Physical Activity(baseline and 6 months)
- Changes in self-regulation(baseline and 6 months)
- Changes in nutrition self-efficacy(baseline and 6 months)
- Physical Activity Readiness(baseline)
- Change in Family Emotional Involvement(baseline and 6 months)
- Change in Family Perceived Criticism(baseline and 6 months)
- Change in Family Collaborative problem solving(baseline and 6 months)
- Change in Family Cohesion(baseline and 6 months)
- Personal Network Survey(baseline)