Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health
ADAPT-MCH
2 other identifiers
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2025
CompletedFirst Posted
Study publicly available on registry
April 24, 2025
CompletedStudy Start
First participant enrolled
June 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
March 3, 2026
February 1, 2026
1.4 years
April 9, 2025
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Feasibility of recruitment - Proportion of eligible patients who enroll
Proportion of eligible patients who enroll in the study based on study logs
Baseline
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
Month 6
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.
Month 3
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
Month 6
Secondary Outcomes (10)
Incidence of Gestational diabetes
Month 6
Gestational weight gain
Post-delivery
Incidence of Pre-eclampsia
Post-delivery
Number of Community resources uses
month 6
Infant birth weight at the time of delivery
Baseline
- +5 more secondary outcomes
Other Outcomes (5)
Food expenditures
Month 6
Fruit and vegetable intake
Month 6
Depressive symptoms Scores
Month 6
- +2 more other outcomes
Study Arms (4)
Electronic Health Record (EHR) referral to Women, Infants and Children (WIC)
ACTIVE COMPARATORParticipants 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 (EHR) referral to Women, Infants and Children (WIC) + care navigation
EXPERIMENTALParticipants 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).
Produce prescriptions
EXPERIMENTALParticipants 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
EXPERIMENTALMedically 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.
Interventions
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.
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).
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
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.
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Related Publications (1)
Palakshappa D, Stone RJ, Ramirez B, White SE, Rigdon J, Bundy R, Eagleton SG, Caudill N, Martin H, Grundseth M, Best S, Mongraw-Chaffin M, Lewis KH, Montez K. Feasibility of an ADAPTive intervention to improve food security and Maternal-Child Health (ADAPT-MCH): Protocol for a pilot sequential multiple assignment randomized trial. Contemp Clin Trials. 2025 Nov;158:108086. doi: 10.1016/j.cct.2025.108086. Epub 2025 Sep 18.
PMID: 40975433DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Deepak Palakshappa, MD, MSHP
Wake Forest University Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2025
First Posted
April 24, 2025
Study Start
June 17, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
March 3, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Immediately following publication - no end date
- Access Criteria
- anyone wishing access
All of the individual participant data collected during the trial after deidentification