Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health (ADAPT-MCH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment - Proportion of eligible patients who enroll
研究概览
简要总结
Food insecurity affects up to 30% of pregnancies and leads to worse health in pregnant people and their children, including an increased risk of gestational diabetes, pre-term birth, and future cardiometabolic chronic conditions (e.g., type 2 diabetes and obesity). Interventions are being utilized to address food insecurity in clinical care settings, but patients differ in the support needed to reduce food insecurity and health systems have limited resources to invest in these interventions. Rather than a single intervention, adaptively allocating interventions could be a more effective, equitable, and efficient approach to improve food security; the objectives of this pilot study are to determine the feasibility of recruiting, retaining, and adaptively providing food insecurity interventions to pregnant patients in anticipation of a large, definitive trial in the future.
详细描述
The US is facing a maternal and infant health crisis. Each year in the US there are >700 maternal deaths and >60,000 life-threatening pregnancy events. Despite decreasing in other high-income countries, maternal mortality has increased in recent years in the US with a staggering 1210 maternal deaths in 2019. Importantly, maternal deaths in the US are now less likely to be due to direct complications of childbirth, and are increasingly due to endocrine (e.g. gestational diabetes (GDM)) or cardiovascular (e.g. pre-eclampsia) conditions directly related to obesity and other nutrition-related chronic diseases. One significant contributor to maternal mortality is food insecurity (FI), or the lack of consistent access to the food needed for a healthy life. In 2023, 13.5% of US households, (>40 million people), were food insecure. Households with young children have higher rates of FI. Also, up to 30% of pregnancies are impacted by FI. Pregnant and postpartum women are especially vulnerable to the impacts of FI as they have increased nutritional requirements for the growing fetus and while breastfeeding. FI has been associated with inadequate or excessive gestational weight gain, GDM, and pregnancy-induced hypertension. Excess retained weight after pregnancy has important health consequences including development of type 2 diabetes. GDM and gestational weight retention also confer higher risk of complications in subsequent pregnancies and future cardiovascular disease. Additionally, FI is associated with increased risk of preterm birth and infants being born low birth weight, affecting children's growth trajectories and future risk of developing obesity.
To address the high prevalence of FI and its impact on health, national healthcare organizations, including the Centers for Medicare and Medicaid (CMS) and The American College of Obstetricians and Gynecologists, have recommended that health systems address FI as a routine part of clinical care. The integration of interventions to address FI in different populations, particularly those with nutrition-related conditions, has been termed "Food is Medicine". CMS has been piloting Food is Medicine interventions as part of Medicaid reform in several states, including North Carolina. Three "Food is Medicine" interventions that are being studied and used by health systems and insurers include: 1) referring patients to government benefits intended to support nutrition or directly providing food through the use of 2) produce prescriptions and 3) medically-tailored meals. Despite the growing use of FI interventions in clinical care settings, a 2023 systematic review highlighted the need for more research on healthcare system-based interventions to reduce FI in pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Single (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
- •≥18 years of age
- •Confirmed viable pregnancy by their obstetrician or midwife based on urine pregnancy test and ultrasound
- •Experience Food Insecurity (FI) based on the 2-item Hunger Vital Sign
- •Speaks English or Spanish
- •Not currently enrolled in WIC
- •First trimester at the time of the initial prenatal visit
排除标准
- •Planning on moving out of the area within 6 months
- •Severe cognitive impairment or major psychiatric illness that prevents consent or serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)
- •Lack safe, stable residence or the ability to store the medically tailored meals (MTM)
- •Lack of a telephone
- •Severe food allergy or require a specialized diet (e.g., Celiac)
研究组 & 干预措施
Electronic Health Record (EHR) referral to Women, Infants and Children (WIC)
Participants randomized to this intervention will be referred to their county WIC program through an already developed electronic referral process. To enable WIC offices to receive referrals and easily communicate with healthcare teams, our EHR also offers a community provider-facing, read-only EHR version. We have already successfully provided WIC staff with access and training for our ongoing WIC screening and referral pilot in pediatrics.
干预措施: Electronic health record WIC referral (Behavioral)
Electronic Health Record (EHR) referral to Women, Infants and Children (WIC) + care navigation
Participants will receive the same intervention as the electronic WIC referral. In addition, a patient care navigator will meet with the participant at enrollment to discuss any anticipated barriers to accessing WIC. The purpose of the visit is to build rapport and trust and to identify any social and structural barriers to enrolling in WIC. The navigator will also contact participants at 2 weeks to discuss any additional barriers reported and as necessary after the baseline visit. Specific counseling will be tailored based on individual's needs, for example difficulty with paperwork. The navigator will also assess any additional community resources to assist the participant with FI (e.g., local food pantries).
干预措施: Electronic health record WIC referral + care navigation (Behavioral)
Produce prescriptions
Participants randomized to this arm will receive $10 worth of produce delivered to their home weekly. Participants will receive a weekly delivery of produce for 3 months.
干预措施: Produce prescription (Behavioral)
Medically tailored meals
Medically tailored meals will be delivered weekly to participant's homes for 3 months. During the 3 months, participants will receive 10 medically-tailored refrigerated or frozen meals (5 lunches and 5 dinners) delivered to their home weekly. All meals are planned by a registered dietician. Meals have minimal preparation time, can be heated by stove, oven, or microwave, and will be provided free-of-charge. Because the meals are medically tailored, participants are asked not to share them. Adherence to meals and food sharing will be measured using food consumption diaries.
干预措施: Medically tailored meals (Behavioral)
结局指标
主要结局
Feasibility of recruitment - Proportion of eligible patients who enroll
时间窗: Baseline
Proportion of eligible patients who enroll in the study based on study logs
Feasibility of retention - Proportion of eligible participants
时间窗: Month 6
The proportion of eligible participants who complete 3-month and 6-month follow-up data collection based on study log
Feasibility of re-randomization - Proportion of eligible participants
时间窗: Month 3
The proportion of eligible participants who are re-randomized to a stage 2 intervention based on study log.
Food insecurity Scores
时间窗: Month 6
Survey participants using the validated 10-item USDA Adult FSSM, with a 30-day look back period. The tool measures food security over the prior 30 days. Using the standardized scoring provided by the USDA to assess participants responses. This produces a raw score that ranges from 0 to 10 with higher scores indicating worse FI. High Food Security: Raw score of 0. Marginal Food Security: Raw score of 1-2. Low Food Security: Raw score of 3-5. Very Low Food Security: Raw score of 6-1
次要结局
- Infant birth weight at the time of delivery(Baseline)
- Infant gestational age at the time of delivery(Baseline)
- Post delivery outcomes - Number of vaginal versus c-section Deliveries(Baseline)
- Incidence of Gestational diabetes(Month 6)
- Gestational weight gain(Post-delivery)
- Incidence of Pre-eclampsia(Post-delivery)
- Number of Community resources uses(month 6)
- Post delivery outcomes - infant APGARS Scores(Baseline)
- Post delivery outcomes - breastfeeding status(Baseline)
- Number of Glucose homeostasis episodes(Baseline and month 6)
