ProduceRx: Improving Weight and Cardiovascular Risk in Adults With Food Insecurity and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Dietary quality
研究概览
简要总结
This is a pilot randomized controlled trial to assess the effects of providing produce vouchers during behavioral weight loss treatment in 40 adults with obesity and food insecurity. Participants will be randomized to ProduceRx (12 weekly sessions of in-person, behavioral weight loss counseling (BWL) + produce prescriptions) or a waitlist control (WLC).
详细描述
The proposed investigation is a single-site, pilot RCT to assess the effect of BWL and produce vouchers (ProduceRx) on diet quality, weight loss and cardiovascular risk factors among adult participants with food insecurity and obesity. Adults (N=40) will be randomized to a 12-week program that provides weekly, 30-minute BWL sessions + produce vouchers (n=20) or WLC (n=20). Outcomes will be assessed at baseline and at 12 weeks and include questionnaires, and measurements of weight, height, and cardiometabolic risk factors (blood pressure, waist circumference, and pulse). Participants will also be asked to complete two 24-hour dietary recalls.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years old
- •BMI ≥ 30 kg/m2
- •Food insecurity as assessed by the two-item "hunger vital sign"
- •Subjects must:
- •have reliable telephone or Internet service to communicate with study staff
- •plan to remain in the Philadelphia area for the next 6 months or more
- •Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent.
排除标准
- •Pregnant, nursing, or plans to become pregnant in the next 6 months
- •Serious medical risk such as uncontrolled diabetes, cancer, congestive heart failure, or recent cardiac event (e.g., myocardial infarction or stroke within the past 6 months)
- •Clinically significant hepatic or renal disease
- •History of (or plans for) bariatric surgery
- •Current psychiatric disorder that significantly interferes with daily living
- •Self-reported alcohol or substance abuse within the past 12 months
- •Use in past 3 months of medications known to induce significant weight loss (i.e., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
- •Loss of ≥ 10 lb of body weight within the past 3 months
- •Participation in a structured weight loss program in the prior 6 months
- •Inability to walk 2 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming)
- •Participant from same household
- •Inability to attend treatment and/or assessment visits
- •Lack of capacity to provide informed consent
- •Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study
结局指标
主要结局
Dietary quality
时间窗: Baseline, 12 weeks
Change from baseline to 12 weeks in dietary quality from 24-hour dietary recalls summarized into Healthy Eating Index (HEI) Scores and caloric intake. Scores range from 0 to 100 with higher scores indicating better diet quality.
次要结局
- Pulse(Baseline, 12 weeks)
- Percent initial weight loss(Baseline, 12 weeks)
- Systolic blood pressure(Baseline, 12 weeks)
- Perceived Stress Scale(Baseline, 12 weeks)
- Diastolic blood pressure(Baseline, 12 weeks)
- Food security(Baseline, 12 weeks)
- Waist circumference(Baseline, 12 weeks)
- Health-related quality of life(Baseline, 12 weeks)
- Depressive symptoms(Baseline, 12 weeks)
- Eating behaviors(Baseline, 12 weeks)
- Self-regulation of eating(Baseline, 12 weeks)
- Physical activity(Baseline, 12 weeks)
- Weight-related quality of life(Baseline, 12 weeks)
- Food addiction(Baseline, 12 weeks)
- Self-regulation of exercise(Baseline, 12 weeks)
- Self-efficacy(Baseline, 12 weeks)