- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06428578
Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas
May 20, 2024 updated by: Alexandra van den Berg, The University of Texas Health Science Center, Houston
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexandra van den Berg, MPH, PhD
- Phone Number: (512) 391-2529
- Email: Alexandra.E.VanDenBerg@uth.tmc.edu
Study Contact Backup
- Name: Aida Nielsen, MPH
- Phone Number: (512) 482-6183
- Email: Aida.Nielsen@uth.tmc.edu
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78705
- Recruiting
- Ascension Seton Medical Center
-
Contact:
- Aida Nielsen, MPH
- Phone Number: (512) 482-6183
- Email: Aida.Nielsen@uth.tmc.edu
-
Contact:
- Alexandra van den Berg, MPH,PhD
- Phone Number: 512-391-2529
- Email: Alexandra.E.VanDenBerg@uth.tmc.edu
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas Health Science Center at Houston
-
Contact:
- Alexandra van den Berg, MPH, PhD
- Phone Number: 512-391-2529
- Email: Alexandra.E.VanDenBerg@uth.tmc.edu
-
Contact:
- Aida Nielsen
- Phone Number: (512) 482-6160
- Email: Aida.Nielsen@uth.tmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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.
|
Experimental: FBM-Virtual
|
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.
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.
|
Active Comparator: home delivered food
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
Time Frame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
|
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
Time Frame: Baseline
|
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)
|
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
|
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
|
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
Time Frame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
|
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
Time Frame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
|
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
Time Frame: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Alexandra van den Berg, MPH, PhD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
May 20, 2024
First Submitted That Met QC Criteria
May 20, 2024
First Posted (Actual)
May 24, 2024
Study Record Updates
Last Update Posted (Actual)
May 24, 2024
Last Update Submitted That Met QC Criteria
May 20, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC-SPH-23-0795
- 24FIM1264463 (Other Grant/Funding Number: American Heart Association)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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