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| ID | Type | Description | Link |
|---|---|---|---|
| 24FIM1264463 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FBM-In person | Experimental |
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| FBM-Virtual | Experimental |
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| home delivered food | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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:
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Alexandra van den Berg, MPH, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascension Seton Medical Center | Recruiting | Austin | Texas | 78705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42374551 | Derived | Nielsen A, Falzone A, Reyes C, Polinard E, Threadgould V, Ranjit N, Marin MD, Gonzalez A, Tello M, Abel A, Chevalier J, Fischweicher A, van den Berg A. Food is the Best Medicine (FBM): design and baseline findings from a multi-arm randomized controlled trial among food-insecure postpartum mothers in Texas. BMC Nutr. 2026 Jun 30. doi: 10.1186/s40795-026-01406-0. Online ahead of print. |
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| 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. |
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| 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. |
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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 |
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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