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

NCT06428578 | Recruiting

• 2 other identifiers: HSC-SPH-23-079524FIM1264463
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (9)

• 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: 1. fruit 2. green leafy or lettuce salad 3. fried potatoes 4. other kind of potatoes 5. refired/baked/ cooked beans 6. other vegetables that were not deep-fried 7. salsa made with tomato 8. pizza 9. tomato sauce 10. lean protein 11. plant-based protein 12. brown rice or other cooked whole grains 13. whole grain bread 14. 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

Study Arms (3)

FBM-In person

EXPERIMENTAL

Other: FBM-In person; Other: home delivered food boxes

FBM-Virtual

EXPERIMENTAL

Other: FBM-Virtual; Other: home delivered food boxes

home delivered food

ACTIVE COMPARATOR

Other: home delivered food boxes

Interventions

FBM-In person OTHER

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-In person

FBM-Virtual OTHER

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.

FBM-Virtual

home delivered food boxes OTHER

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.

FBM-In person; FBM-Virtual; home delivered food

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• food insecure
• to communicate in English or Spanish.

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• American Heart Association: collaborator

Study Sites (2)

Ascension Seton Medical Center

Austin, Texas, 78705, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Alexandra van den Berg, MPH, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra van den Berg, MPH, PhD

CONTACT

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

Aida Nielsen, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)