LA-CEAL CONNECT: Louisiana Community Engagement Alliance (LA-CEAL) Collaborative Multi-level Obesity Intervention Engaging Communities Trial (CONNECT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 522
- 试验地点
- 18
- 主要终点
- Between-group difference in % weight change
研究概览
简要总结
The goal of this clinical trial is to test the effectiveness of an evidence-based multi-level intervention for weight loss and the feasibility, fidelity, and sustainability of implementing the intervention in people living with obesity in Louisiana. The main questions it aims to answer are:
- Will an evidence-based multi-level obesity intervention (called LA-CEAL CONNECT) in Louisiana communities achieve weight loss at 6 months compared to enhanced usual care?
- Will LA-CEAL CONNECT sustain weight loss at 12 months?
- Will LA-CEAL CONNECT improve waist circumference, diet quality, physical activity, quality of life, and blood pressure at 6 and 12 months?
- Will LA-CEAL CONNECT be feasible to implement in adults living with obesity in Louisiana communities?
Researchers will compare the LA-CEAL CONNECT multilevel weight loss intervention to enhanced usual care to evaluate if LA-CEAL CONNECT leads to greater weight loss and greater changes in waist circumference, diet, physical activity, quality of life, and blood pressure than enhanced usual care.
Participants in both arms will:
- Receive health literacy-tailored educational materials and resources for weight loss
- Visit the clinic site for baseline, 6-month and 12-month study visits to collect clinical and survey measurements
Participants in the CONNECT intervention arm will also:
- receive health coaching
- self-monitor weight and physical activity using digital technologies
- attend group meetings to identify and increase utilization of community health and wellness resources
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
- 否
入选标准
- •being 18 to 75 years of age
- •living with obesity, defined as a BMI between 30 and 50 kg/m2 for non-Asian identifying participants and BMI between 27.5 and 50 kg/m2 for Asian-identifying participants
- •weighing less than 400 pounds
- •receiving care from or willing to register at a participating FQHC clinic
- •able to understand and speak English
- •able to complete the study within the next year (e.g., not planning to move from the area within study period)
排除标准
- •having given birth within the past year, pregnant or planning to become pregnant during study period (within 1 year)
- •currently participating in a weight-loss program
- •having lost more than 10 pounds in the last 6 months
- •being an employee or a family member of an employee of any participating FQHC
- •having a disease that can interfere with or be aggravated by exercise or weight loss
研究组 & 干预措施
LA-CEAL CONNECT Intervention
Participants will receive: 1) culturally tailored and health literacy-appropriate educational materials about weight loss and obesity, 2) health coaching from community health workers over 6 months, and 3) digital weight scale and fitness tracker (e.g., Fitbit).
Communities will receive support to conduct Community Asset Mapping and design and implement Community Action Projects to promote health resources in their community.
FQHC clinic providers will receive: 1) education on guideline-based obesity management, 2) toolkit with resources for obesity management.
干预措施: Health Literacy and Culturally Tailored Materials (Behavioral)
LA-CEAL CONNECT Intervention
Participants will receive: 1) culturally tailored and health literacy-appropriate educational materials about weight loss and obesity, 2) health coaching from community health workers over 6 months, and 3) digital weight scale and fitness tracker (e.g., Fitbit).
Communities will receive support to conduct Community Asset Mapping and design and implement Community Action Projects to promote health resources in their community.
FQHC clinic providers will receive: 1) education on guideline-based obesity management, 2) toolkit with resources for obesity management.
干预措施: Self-Monitoring and Remote Patient Monitoring of weight and physical activity (Behavioral)
LA-CEAL CONNECT Intervention
Participants will receive: 1) culturally tailored and health literacy-appropriate educational materials about weight loss and obesity, 2) health coaching from community health workers over 6 months, and 3) digital weight scale and fitness tracker (e.g., Fitbit).
Communities will receive support to conduct Community Asset Mapping and design and implement Community Action Projects to promote health resources in their community.
FQHC clinic providers will receive: 1) education on guideline-based obesity management, 2) toolkit with resources for obesity management.
干预措施: Community Asset Mapping (CAM) (Other)
LA-CEAL CONNECT Intervention
Participants will receive: 1) culturally tailored and health literacy-appropriate educational materials about weight loss and obesity, 2) health coaching from community health workers over 6 months, and 3) digital weight scale and fitness tracker (e.g., Fitbit).
Communities will receive support to conduct Community Asset Mapping and design and implement Community Action Projects to promote health resources in their community.
FQHC clinic providers will receive: 1) education on guideline-based obesity management, 2) toolkit with resources for obesity management.
干预措施: Obesity Toolkit for Primary Care Providers (Other)
Enhanced Usual Care
Participants will receive culturally tailored and health literacy-appropriate educational materials about weight loss and obesity. FQHC clinic providers will receive education on obesity management.
干预措施: Health Literacy and Culturally Tailored Materials (Behavioral)
LA-CEAL CONNECT Intervention
Participants will receive: 1) culturally tailored and health literacy-appropriate educational materials about weight loss and obesity, 2) health coaching from community health workers over 6 months, and 3) digital weight scale and fitness tracker (e.g., Fitbit).
Communities will receive support to conduct Community Asset Mapping and design and implement Community Action Projects to promote health resources in their community.
FQHC clinic providers will receive: 1) education on guideline-based obesity management, 2) toolkit with resources for obesity management.
干预措施: Community-Engaged Health Coaching and Navigation (Behavioral)
LA-CEAL CONNECT Intervention
Participants will receive: 1) culturally tailored and health literacy-appropriate educational materials about weight loss and obesity, 2) health coaching from community health workers over 6 months, and 3) digital weight scale and fitness tracker (e.g., Fitbit).
Communities will receive support to conduct Community Asset Mapping and design and implement Community Action Projects to promote health resources in their community.
FQHC clinic providers will receive: 1) education on guideline-based obesity management, 2) toolkit with resources for obesity management.
干预措施: Primary Care Provider Training (Other)
Enhanced Usual Care
Participants will receive culturally tailored and health literacy-appropriate educational materials about weight loss and obesity. FQHC clinic providers will receive education on obesity management.
干预措施: Primary Care Provider Training (Other)
结局指标
主要结局
Between-group difference in % weight change
时间窗: 6 months
Trained personnel will measure weight at all visits using a digital weight scale. For weight, measurement will be performed twice, with a third measurement if the first 2 measurements deviate more than 0.1 kg. An average of the two closest measurements will be used for analyses.
次要结局
- Between-group difference in change in waist circumference(6 months)
- Between-group difference in change in blood pressure(6 months)
- Between-group difference in change in dietary intake(6 months)
- Between-group difference in change in physical activity(6 months)
- Between-group difference in change in quality of life(6 months)