## Protocol Section
### Identification Module
**NCT ID:** NCT06428578

**Brief Title:** 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

#### Organization Study ID Info
**ID:** HSC-SPH-23-0795
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center, Houston
#### Secondary ID Infos
**Domain:** American Heart Association
**ID:** 24FIM1264463
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** American Heart Association

#### Lead Sponsor

**Class:** OTHER

**Name:** The University of Texas Health Science Center, Houston

#### Responsible Party

**Investigator Affiliation:** The University of Texas Health Science Center, Houston

**Investigator Full Name:** Alexandra van den Berg

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: FBM-In person

- Other: home delivered food boxes

**Label:** FBM-In person

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: FBM-Virtual

- Other: home delivered food boxes

**Label:** FBM-Virtual

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Other: home delivered food boxes

**Label:** home delivered food

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- FBM-In person

**Description:** 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.

**Name:** FBM-In person

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- FBM-Virtual

**Description:** 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.

**Name:** FBM-Virtual

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- FBM-In person

- FBM-Virtual

- home delivered food

**Description:** 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.

**Name:** home delivered food boxes

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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

**Description:** 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

**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

**Time Frame:** 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

**Time Frame:** Baseline

**Measure:** Total duration of breastfeeding time as assessed by the post test questionnaires

**Time Frame:** end of study (after 8 weeks of food delivery boxes)

**Measure:** Total duration of breastfeeding time as assessed by the post test questionnaires

**Time Frame:** 3 months follow up

**Description:** 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

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** A single item from the Financial Self Efficacy scale will be used.

**Measure:** 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

### Eligibility Module

**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.

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Alexandra.E.VanDenBerg@uth.tmc.edu

**Name:** Alexandra van den Berg, MPH, PhD

**Phone:** (512) 391-2529

**Role:** CONTACT

**Contact 2:**

**Email:** Aida.Nielsen@uth.tmc.edu

**Name:** Aida Nielsen, MPH

**Phone:** (512) 482-6183

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Austin

**Contacts:**

***Contact 1:***

- **Email:** Alexandra.E.VanDenBerg@uth.tmc.edu

- **Name:** Alexandra van den Berg, MPH,PhD

- **Phone:** 512-391-2529

- **Role:** CONTACT

***Contact 2:***

- **Email:** Aida.Nielsen@uth.tmc.edu

- **Name:** Aida Nielsen, MPH

- **Phone:** (512) 482-6183

- **Role:** CONTACT

**Country:** United States

**Facility:** Ascension Seton Medical Center

**State:** Texas

**Status:** RECRUITING

**Zip:** 78705

**Location 2:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Email:** Alexandra.E.VanDenBerg@uth.tmc.edu

- **Name:** Alexandra van den Berg, MPH, PhD

- **Phone:** 512-391-2529

- **Role:** CONTACT

***Contact 2:***

- **Email:** Aida.Nielsen@uth.tmc.edu

- **Name:** Aida Nielsen

- **Phone:** (512) 482-6160

- **Role:** CONTACT

**Country:** United States

**Facility:** The University of Texas Health Science Center at Houston

**State:** Texas

**Status:** RECRUITING

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** The University of Texas Health Science Center, Houston

**Name:** Alexandra van den Berg, MPH, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
