Comparative Effectiveness of Two Interventions to Reduce Food Insecurity During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in Food Security
研究概览
简要总结
This study aims to compare the effectiveness of two interventions to address food insecurity among low-income families with young children during the COVID pandemic. The investigators will conduct a parallel group, randomized controlled trial of 250 families. The first randomly assigned comparator is Fresh Connect, a produce prescription program that provides a stipend for participants to purchase fresh food items at mobile markets and independent farmers markets across Boston. The second comparator is grocery store gift cards, redeemable at conventional grocery stores. In each comparator, participants will be given the equivalent of $150 on a monthly basis for six consecutive months. All participants will be followed for 12 months to assess outcomes that involve food insecurity (primary), fruit and vegetable consumption, healthcare utilization, social service utilization, and physical/emotional health.
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
- Double (Investigator, Outcomes Assessor)
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
- •Parent of a child 0-18 months of age
- •Child receives care at Boston Medical Center
排除标准
- •Planning to move residence outside of Boston within 12 months
研究组 & 干预措施
Fresh Connect Produce Prescription Program
Investigators will partner with a community organization, About Fresh, that administers a produce prescription program (PPR) and operates mobile fresh foods markets. Participants randomized to this comparator will receive a stipend to Fresh Connect PPR to purchase fresh food items available at mobile markets and at independent farmers markets throughout Boston.
干预措施: Produce prescription program (Other)
Grocery store gift cards
Participants randomized to this comparator will receive grocery gift cards redeemable at conventional grocery stores.
干预措施: Grocery store gift cards (Other)
结局指标
主要结局
Change in Food Security
时间窗: Baseline, monthly for 12-months post-enrollment
Self-reported food security status measured by USDA validated 18-question food insecurity screening tool with a 30-day lookback period. Responses are scored with total scores corresponding to four categories: high food security, marginal food security, low food security, and very low food security
次要结局
- Child height(Baseline, every 6 months during 12 month post-enrollment)
- Change in fruit & vegetable consumption(Baseline, monthly for 12 months post-enrollment)
- Depression Symptoms(Baseline, monthly for 12-months post-enrollment)
- Symptom Relief(Baseline, monthly for 12-months post-enrollment)
- Changes of behavioral activation for depression(Baseline, every 6 months during 12 month post-enrollment)
- Perceived Stress(Baseline, every 6 months during 12 month post-enrollment)
- Social Support(Baseline, every 6 months during 12 month post-enrollment)
- Medical outcomes social support(Baseline, every 6 months during 12 month post-enrollment)
- Child healthcare utilization(Baseline, every 6 months during 12 month post-enrollment)
- Child weight(Baseline, every 6 months during 12 month post-enrollment)
- Self-Reported Food Assistance Program Participation(Baseline, every 6 months during 12 month post-enrollment)
- Mastery Control(Baseline, every 6 months during 12 month post-enrollment)
- Self-Esteem(Baseline, every 6 months during 12 month post-enrollment)
- Unmet needs(Baseline, every 3 months during 12 month post-enrollment)
- Change in Self-Reported Health Status(Baseline, monthly for 12-months post-enrollment)
- Maternal attitudes and safe infant care practices(Baseline, every 6 months during 12 month post-enrollment)
- Impact of COVID-19(Baseline, every 3 months during 12 month post-enrollment)
- Program Experience(6 months post-enrollment, 12 months post-enrollment)
- Change in adult acute healthcare utilization(Baseline, every 6 months during 12 month post-enrollment)
- Total adult patient-level cost of care(Baseline, every 6 months during 12 month post-enrollment)