Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Produce prescription
BehavioralParticipants 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.
Medically tailored meals
BehavioralMedically 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
Electronic health record WIC referral
BehavioralParticipants 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.
Electronic health record WIC referral + care navigation
BehavioralParticipants 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).
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Electronic Health Record (EHR) referral to Women, Infants and Children (WIC)Active comparator 1 intervention
Group B: Electronic Health Record (EHR) referral to Women, Infants and Children (WIC) + care navigationExperimental treatment 1 intervention
Group C: Produce prescriptionsExperimental treatment 1 intervention
Group D: Medically tailored mealsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of recruitment - Proportion of eligible patients who enroll
Proportion of eligible patients who enroll in the study based on study logs
Time frame
Baseline2
Feasibility of retention - Proportion of eligible participants
The proportion of eligible participants who complete 3-month and 6-month follow-up data collection based on study log
Time frame
Month 63
Feasibility of re-randomization - Proportion of eligible participants
The proportion of eligible participants who are re-randomized to a stage 2 intervention based on study log.
Time frame
Month 34
Food insecurity Scores
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
Time frame
Month 6Secondary outcomes
1
Incidence of Gestational diabetes
Differences in the incidence of gestational diabetes over time based on data extraction from the electronic health record.
Time frame
Month 62
Gestational weight gain
We will determine the proportion of individuals with excess gestational weight gain. Will be determined by data extraction from the electronic health record and defined as the following: If pre-pregnancy BMI ≥30, gaining ≥20lbs; if BMI 25-29.9, gaining ≥25lbs; if BMI \<25, gaining ≥35lbs.
Time frame
Post-delivery3
Incidence of Pre-eclampsia
Incident number of diagnoses at outpatient, emergency department or hospital encounter based on ICD-10 codes through data extraction from the electronic health record
Time frame
Post-delivery4
Number of Community resources uses
Change in the number of community resources used (e.g. food pantries, supplemental nutrition assistance program) based on self-report in the study survey.
Time frame
month 6Other outcomes
1
Food expenditures
Report of out-of-pocket monthly expenditures on food based on study survey
Time frame
Month 62
Fruit and vegetable intake
Change fruit and vegetable intake over time based on the National Cancer Institute's (NCI) Fruit and Vegetable screener. The NCI Fruit and Vegetable screener measure the frequency and usual portion size for 9 fruit and vegetable components over the prior month.
Time frame
Month 63
Depressive symptoms Scores
Change in depressive symptoms over time based on data extraction from the electronic health record. Depressive systems are collected at each OB visit using the validated Patient Health Questionnaire-2 (PHQ-2). Those with a positive PHQ-2 are reflexively assessed using the full PHQ-9. Scores range from 0-27 with higher scores representing a higher number of depressive systems.
Time frame
Month 64
Stress Scores
Change in stress based on the Perceived Stress Scale as part of the study survey. Scores range from 0-40 with higher scores representing higher perceived stress.
Time frame
Month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov