Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas

The purpose of this study is to compare the short-term and long term impacts of Food is the Best Medicine (FBM)-Virtual on diet quality, food security status, breastfeeding rates, mental health status, rates of home cooking, and rationing coping strategies relative to FBM-In Person among food insecure, postpartum women and to compare implementation outcomes across the FBM-Virtual and FBM-In Person using process data collected from the participants, Community Health Worker (CHW)s, and partner organizations.

Study Overview

• Status: Recruiting
• Conditions: Food Insecurity in Post Partum Women
• Intervention / Treatment: Other: FBM-In person; Other: home delivered food boxes; Other: FBM-Virtual

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandra van den Berg, MPH, PhD; Phone Number: (512) 391-2529; Email: Alexandra.E.VanDenBerg@uth.tmc.edu
• Study Contact Backup: Name: Aida Nielsen, MPH; Phone Number: (512) 482-6183; Email: Aida.Nielsen@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Ascension Seton Medical Center
      • Contact: Aida Nielsen, MPH; Phone Number: (512) 482-6183; Email: Aida.Nielsen@uth.tmc.edu
      • Contact: Alexandra van den Berg, MPH,PhD; Phone Number: 512-391-2529; Email: Alexandra.E.VanDenBerg@uth.tmc.edu
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Alexandra van den Berg, MPH, PhD; Phone Number: 512-391-2529; Email: Alexandra.E.VanDenBerg@uth.tmc.edu
      • Contact: Aida Nielsen; Phone Number: (512) 482-6160; Email: Aida.Nielsen@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• food insecure
• to communicate in English or Spanish.

Exclusion Criteria:

• not living within the food produce zip code delivery radius
• having any dietary allergies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FBM-In person	Other: FBM-In person; Participants will receive two home visits by a CHW. Each home visit will last about 30 minutes, during which the CHW will assist the woman with community resources and help with enrolling in any state or federal nutrition and medical programs. Furthermore, the participants will be given access to a private Facebook group for nutrition, health education, and social support. Home visits will occur during the second and fifth weeks of the study.; Other: home delivered food boxes; Participants will receive weekly deliveries of a box containing fresh produce and staple goods (approximately 5 meals a week), culturally tailored meals (6 meals a week), and prepared fruit, vegetable and grain-forward meal kits (4 units a week) plus standard nutrition education materials consisting of recipes inside of the boxes. Each participant will receive one box for eight consecutive weeks.
Experimental: FBM-Virtual	Other: home delivered food boxes; Participants will receive weekly deliveries of a box containing fresh produce and staple goods (approximately 5 meals a week), culturally tailored meals (6 meals a week), and prepared fruit, vegetable and grain-forward meal kits (4 units a week) plus standard nutrition education materials consisting of recipes inside of the boxes. Each participant will receive one box for eight consecutive weeks.; Other: FBM-Virtual; Participants will receive access to a virtual platform which will have information on national, state, and local food and medical resources, as well as local community resources, and will have access to a private Facebook group for nutrition, health education, and social support.
Active Comparator: home delivered food	Other: home delivered food boxes; Participants will receive weekly deliveries of a box containing fresh produce and staple goods (approximately 5 meals a week), culturally tailored meals (6 meals a week), and prepared fruit, vegetable and grain-forward meal kits (4 units a week) plus standard nutrition education materials consisting of recipes inside of the boxes. Each participant will receive one box for eight consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of household food insecurity experienced as assessed by the US Household Food Security questionnaire	This is an 6 item questionnaire . Raw score will be reported and score ranges from 0-6. Raw score of 0-1 shows high or marginal food security, raw score of 2- indicates low food security and raw score of 5-6 shows very low food insecurity.	Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Change in quality of diet as assessed by number of times participants ate certain food items in the past month as reported in the questionnaire	This data will be reported categorically for 14 different food items as follows: fruit; green leafy or lettuce salad; fried potatoes; other kind of potatoes; refired/baked/ cooked beans; other vegetables that were not deep-fried; salsa made with tomato; pizza; tomato sauce; lean protein; plant-based protein; brown rice or other cooked whole grains; whole grain bread; regular soda/pop	Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Number of participants that initiated breastfeeding as assessed by the pre test questionnaire		Baseline
Total duration of breastfeeding time as assessed by the post test questionnaires		end of study (after 8 weeks of food delivery boxes)
Total duration of breastfeeding time as assessed by the post test questionnaires		3 months follow up
Change in number of participants who showed signs of depression as assessed by the Edinburgh Postnatal Depression Scale (EPDS)	This is a 10 item questionnaire , range of score for each item is 0-3 for a total score range of 0-30, score above 12 is worse outcome	Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Change in number of cooked meals as assessed by the number of home cooked meals made from scratch during the past week	Participant will be asked how often he/she or anyone else in the family prepared breakfast from scratch during the past week, lunch from scratch during the past week or dinner from scratch during the past week. The responses from the 3 items will be summed to determine the number of home cooked meals during past week.	Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Change in financial stress as assessed by the financial stress questionnaire	Scores for three questions from the Financial Stress Scale will be used and each will be scored from 0(never) to 6(Always) for a score range of 0-18; 18 being highest level of financial stress.	Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Percentage of participants that face financial challenges as assessed by the Financial Self-Efficacy Scale	A single item from the Financial Self Efficacy scale will be used.	Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Alexandra van den Berg, MPH, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Community Health Workers; food insecurity; Food is Medicine (FIM); free delivered nutritious meals; food boxes; The University of Texas Health Science Center at Houston School of Public Health; Austin
• Other Study ID Numbers: HSC-SPH-23-0795; 24FIM1264463 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No