The Maternal Well-Being Study: A Feasibility and Acceptability Trial of Postpartum Support Interventions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- % of meals delivered to and consumed by subjects
研究概览
简要总结
This project aims to understand the local feasibility and acceptability of MamaMeals (a home-delivered nutritious, postpartum meal delivery program) and MamaMatters (a moderated social media-based peer support group) among peripartum women who are eligible for federal supplemental nutrition assistance programs such as The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) or Supplemental Nutrition Assistance Program (SNAP). The investigators will conduct a prospective randomized controlled trial (RCT) of these two interventions among postpartum individuals. Analyses will be performed to determine the relative risk of postpartum depressive or anxiety symptoms (primary outcome) and overall well-being and maternal/infant health (secondary/exploratory outcomes) between groups. Findings from this pilot intervention study will inform a future, large RCT exploring the effectiveness of MamaMeals and/or MamaMatters on reducing postpartum mental health symptoms and cardiovascular morbidity among individuals with food insecurity during and after pregnancy.
详细描述
- To assess the local feasibility and acceptability of MamaMeals (home-delivered, nutritious meals) during the 4th trimester for mothers with peripartum food insecurity.
- To explore perceptions about receiving a medically-tailored meal delivery intervention during the 4th trimester (MamaMeals) among a diverse sample of peripartum individuals with food insecurity (FI).
- To assess through a randomized trial the potential efficacy of the MamaMeals (nutritious, home-delivered meals) and MamaMatters (ehealth postpartum support) interventions on peripartum mood disorders (primary outcome), postpartum cardiometabolic risk* (exploratory outcome), maternal wellbeing (exploratory outcome), and infant health (exploratory outcome) during the first 12 months following delivery. Hypothesis: Individuals who receive the MamaMeals + MamaMatters interventions will have lower Edinburgh Postpartum Depression Scale (EPDS) scores throughout the first 12 weeks postpartum compared to groups receiving only one intervention or the control group.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •screen positive for food insecurity or qualify for any of the following governmental assistance programs Medicaid, WIC, SNAP, TANF,
- •speak English,
- •are between 20-40 completed weeks of pregnancy,
- •are ages 18 years or older.
排除标准
- •type 1 diabetes
- •dietary contraindications (e.g., severe food allergy, or inflammatory bowel disease, celiac disease, chronic renal disease, bariatric surgery, short bowel syndrome)
- •an active eating disorder (self-reported)
- •hospitalization in the past 12 months for a mental health concern
- •a history of postpartum psychosis
- •Individuals with a history of being banned from any social media site will also be excluded.
研究组 & 干预措施
Dual interventions
Receive both interventions: MamaMeals and MamaMatters Interventions
干预措施: Meals (Other)
Dual interventions
Receive both interventions: MamaMeals and MamaMatters Interventions
干预措施: Meals + Social Support (Other)
Meals intervention only
MamaMeals
干预措施: Meals (Other)
Control
Wait-list control (received MamaMeals between 16-20 weeks postpartum) (after primary data collection time point)
干预措施: Control (Other)
结局指标
主要结局
% of meals delivered to and consumed by subjects
时间窗: 12 weeks
Feasibility of meal delivery social media support delivery
perception of the nutritious home delivered meal program
时间窗: 12 weeks
subject engagement with interventions and perception of interventions
次要结局
- % of Edinburgh postnatal depression scale score >15 at 12 weeks postpartum(12 weeks)