A Behavioral and Plant-Based Dietary Intervention to Improve Metabolic Health and Diabetes Risk Factors in an Underserved Latino Population
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
The Aims of this study are 1) to develop a traditional plant-based diet that is palatable and acceptable to the Latino population and which contains the appropriate calorie and macronutrient composition needed to lose weight and improve metabolic function and; 2) to develop a culturally sensitive [based on previous literature and stakeholder input] lifestyle intervention program, that will be delivered by community health workers [CHWs], that focuses on consuming a traditional plant-based diet and overcoming the barriers to incorporating this dietary therapy as part of the family lifestyle but with a focus on the adult participant with obesity. Ultimately, in Aim 3 the investigators will conduct a 16-week randomized controlled trial (RCT) in 40 Latino adults with obesity [20 control, 20 treatment] to evaluate the intervention's: i) clinical efficacy; ii) fidelity of the implementation by CHWs; and iii) acceptance by CHWs and study participants.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-reported Hispanic and/or Latino heritage
- •Body Mass Index (BMI) 30-42 kg/m²
- •HbA1c ≤ 6.4%
排除标准
- •Previous diagnosis of diabetes
- •Unstable weight (≥4% during the last 2 months prior to study enrollment)
- •Severe cardiovascular disease within the 6 months prior to study enrollment
- •Severe organ system dysfunction
- •active substance abuse with alcohol or drugs
- •Severe anemia
- •Pregnant or breastfeeding
- •Use of medications that are known to affect the study outcome measures
- •Persons who are not able to grant voluntary informed consent
研究组 & 干预措施
Behavioral and Plant-based Dietary Intervention
In this arm, participants will receive the behavioral plant-based intervention from community health workers.
干预措施: Behavioral plant-based dietary intervention (Behavioral)
Standard Care
In this arm, participants will receive the standard care intervention from community health workers.
干预措施: Standard care (Behavioral)
结局指标
主要结局
Body weight
时间窗: Baseline and immediately after the intervention at 6 months
Percent change in body weight from baseline to post-intervention
次要结局
- Fat mass and fat free mass(Baseline and immediately after the intervention at 6 months)
- Plasma Lipids(Baseline and immediately after the intervention at 6 months)
- Blood pressure(Baseline and immediately after the intervention at 6 months)
- β-cell function(Baseline and immediately after the intervention at 6 months)
- Insulin Clearance(Baseline and immediately after the intervention at 6 months)
- Program acceptability from community health workers and study participants(Immediately after the intervention at 6 months)