A Randomized Pilot Study of Produce Prescription Programs in Adults With Overweight or Obesity Experiencing Nutrition Insecurity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants Reached
研究概览
简要总结
The goal of this study is to understand the best practices for implementing produce prescriptions among adults with overweight or obesity experiencing nutrition insecurity. Enrolled participants will receive an 8-week intervention aimed at increasing nutrition knowledge, self-efficacy for healthy eating, and barriers to healthy food access. Participants will be randomly assigned to one of two produce prescription implementation strategies:
Program 1: Participants will receive weekly produce vouchers that are redeemable at a local vendor.
Program 2. Participants will receive fresh produce delivered directly to the participant's home. These boxes will be tailored based on household size, cooking and preparation preferences, and produce the participant prefers to receive.
Researchers will compare engagement in and adherence to the intervention and the patterns of difference in 8-week changes in fruit and vegetable consumption and weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18 years of age or older
- •Living with overweight or obesity, defined as a BMI ≥25
- •Screens positive for nutrition insecurity
- •Has a smartphone with a data plan
- •Willing to receive daily text messages
- •Has an address that can receive delivery
- •Can read and write in English
- •Is willing to pick up produce at the Northeast Market
排除标准
- •Participating in another related research study
- •Currently taking weight loss drugs
- •Cardiovascular disease event in the last 6 months
- •Active cancer
- •Recent hospitalization due to psychiatric condition or event
- •Pregnancy or planned during the study period
- •Currently breastfeeding
- •Documented dementia
- •On kidney dialysis
- •Planned or recent bariatric surgery
- •Weight exceeding 440 lbs.
- •Exclusion at principal investigators discretion
研究组 & 干预措施
Produce Voucher
Behavioral Text Message Program + Produce Voucher
干预措施: Behavioral Text Message Program and Produce Voucher (Behavioral)
Produce Boxes
Behavioral Text Message Program + Produce Box Delivery
干预措施: Behavioral Text Messages and Produce Box Delivery (Behavioral)
结局指标
主要结局
Number of Participants Reached
时间窗: From screening up to 8 weeks
The investigators will track the number of number of screening completions, number of eligible participants, and number of randomized participants, in addition to number of participants retained.
次要结局
- Nutrition Insecurity as Assessed by the 4-item Nutrition Security Screening Questionnaire(Baseline to 8 weeks)
- Fruit and Vegetable Consumption as Assessed by the 9-item Mini-Eating Assessment Tool (EAT)(Baseline, 4 weeks, and 8 weeks)
- Blood Pressure (mmHg)(Baseline, 8 Weeks)
- Health Self-Efficacy as Assessed by the 11-item Healthy Eating and Weight Self-Efficacy Scale(Baseline, 8 weeks)
- Weight (kg)(Baseline, 8 weeks)