Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health (ADAPT-MCH)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• ≥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

Locations
United States
North Carolina
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Contact Information
Primary
Deepak Palakshappa, MD, MSHP
dpalaksh@wakehealth.edu
336-716-1795
Backup
Rebecca Stone, MPH
rjstone@wakehealth.edu
336-713-5544
Time Frame
Start Date: 2025-06-17
Estimated Completion Date: 2027-02
Participants
Target number of participants: 60
Treatments
Active_comparator: 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
Experimental: 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).
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov