Clinical trial NCT06428578: Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas
Official title: Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2024-05-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in level of household food insecurity experienced as assessed by the US Household Food Security questionnaire
timeFrame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
measure: 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
timeFrame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
measure: Number of participants that initiated breastfeeding as assessed by the pre test questionnaire
timeFrame: Baseline
measure: Total duration of breastfeeding time as assessed by the post test questionnaires
timeFrame: end of study (after 8 weeks of food delivery boxes)
measure: Total duration of breastfeeding time as assessed by the post test questionnaires
timeFrame: 3 months follow up
measure: Change in number of participants who showed signs of depression as assessed by the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
measure: Change in number of cooked meals as assessed by the number of home cooked meals made from scratch during the past week
timeFrame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
measure: Change in financial stress as assessed by the financial stress questionnaire
timeFrame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
measure: Percentage of participants that face financial challenges as assessed by the Financial Self-Efficacy Scale
timeFrame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ascension Seton Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Alexandra van den Berg, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: