Recruiting

FBM-Virtual vs. FBM-In Person

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06428578

Conditions

Food Insecurity in Post Partum Women

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

FBM-In person

FBM-Virtual

home delivered food boxes

Study Details

Brief summary:

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.

Conditions

Food Insecurity in Post Partum Women

Study ID

NCT06428578

Start date

Jan 1, 2024

Status verified date

May, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FBM-In person

experimental: FBM-Virtual

active comparator: home delivered food

Interventions

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.

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.

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.

Primary outcome measure

  • Change in level of household food insecurity experienced as assessed by the US Household Food Security questionnaire [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline ]
  • Total duration of breastfeeding time as assessed by the post test questionnaires [ Time Frame: end of study (after 8 weeks of food delivery boxes) ]
  • Total duration of breastfeeding time as assessed by the post test questionnaires [ Time Frame: 3 months follow up ]
  • Change in number of participants who showed signs of depression as assessed by the Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention ]

Central Contacts and Locations

Central contacts

Alexandra van den Berg, MPH, PhD

(512) 391-2529Alexandra.E.VanDenBerg@uth.tmc.edu

Aida Nielsen, MPH

(512) 482-6183Aida.Nielsen@uth.tmc.edu

Locations

Ascension Seton Medical Center

Recruiting

Austin, Texas, United States, 78705

Contacts

Alexandra van den Berg, MPH,PhD

512-391-2529Alexandra.E.VanDenBerg@uth.tmc.edu

Aida Nielsen, MPH

(512) 482-6183Aida.Nielsen@uth.tmc.edu

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Alexandra van den Berg, MPH, PhD

512-391-2529Alexandra.E.VanDenBerg@uth.tmc.edu

Aida Nielsen

(512) 482-6160Aida.Nielsen@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 24, 2024

Last verified

May, 2024

Keywords

  • Food is Medicine (FIM)
  • food insecurity
  • free delivered nutritious meals
  • food boxes
  • Community Health Workers
  • The University of Texas Health Science Center at Houston School of Public Health
  • Austin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-05-24.