FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)

Официальное название

FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing): Optimization and Evaluation Using Multiphase Optimization Strategy (MOST) and Social Network Analysis (SNA)

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Family Skills Training Session Quantity: 5
  The number of family skills training sessions administered: 5 sessions
• Поведенческое Family Skills Training Session Mode: In-person
  The mode of administration of family skills training sessions: in person or online
• Поведенческое Family Skills Training Content: Communication
  The content of family skills training sessions administered focused on communication and conflict resolution : communication and conflict resolution
• Поведенческое Family Skills Training Content: Cohesion
  The content of family skills training sessions administered focused on cohesion: cohesion or no cohesion
• Поведенческое Family Skills Training Session Quantity: 10
  The number of family skills training sessions administered: 10 sessions
• Поведенческое Family Skills Training Session Mode: Online
  The mode of administration of family skills training sessions: online
• Поведенческое Family Skills Training Content: No Communication
  The content of family skills training sessions administered focused on communication and conflict resolution : no communication and conflict resolution
• Поведенческое Family Skills Training Content: No Cohesion
  The content of family skills training sessions administered focused on cohesion: no cohesion

Первичные конечные точки

• Change in Body weight [Срок оценки: baseline and 6 months]

Вторичные конечные точки (12)

• Mean Change in Blood Pressure [Срок оценки: baseline and 6 months]
• Change in skin carotenoids [Срок оценки: baseline and 6 months]
• Change in physical activity steps [Срок оценки: baseline and 6 months]
• Change in glycosylated hemoglobin (A1c) [Срок оценки: baseline and 6 months]
• Current Subjective Social Status [Срок оценки: baseline]
• Change in Quality of Life [Срок оценки: baseline and 6 months]
• Change in Depression [Срок оценки: baseline and 6 months]
• Change in Perceived stress [Срок оценки: baseline and 6 months]
• Change for social support for exercise [Срок оценки: baseline and 6 months]
• Change in Self-Efficacy of Eating Behaviors [Срок оценки: baseline and 6 months]
• Change in Self-Efficacy of Physical Activity [Срок оценки: baseline and 6 months]
• Changes in self-regulation [Срок оценки: baseline and 6 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of North Carolina at Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT06724406 · 24-1302 · R61HL169357

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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