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Behavioural Intervention
Food Program for Malnutrition
N/A
Recruiting
Led By Alexandra van den Berg, MPH, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be able to communicate in English or Spanish
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare the effects of a virtual program called Food is the Best Medicine with an in-person version on diet quality, food security, breastfeeding rates, mental health, home cooking, and coping
Who is the study for?
This trial is for food insecure postpartum women who can communicate in English or Spanish. Participants must live within certain zip codes where home-delivered food boxes are available and should not have any dietary allergies.
What is being tested?
The study compares two programs: 'Food is the Best Medicine' (FBM) delivered virtually, and FBM in person. It looks at how these affect diet quality, food security, breastfeeding rates, mental health, cooking at home frequency, and coping strategies for rationing food.
What are the potential side effects?
Since this trial involves nutritional interventions rather than medications, side effects may include changes in digestion due to different diets or potential stress from participating in the program's activities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can communicate in English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in financial stress as assessed by the financial stress questionnaire
Change in level of household food insecurity experienced as assessed by the US Household Food Security questionnaire
Change in number of cooked meals as assessed by the number of home cooked meals made from scratch during the past week
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: FBM-VirtualExperimental Treatment2 Interventions
Group II: FBM-In personExperimental Treatment2 Interventions
Group III: home delivered foodActive Control1 Intervention
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Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
940 Previous Clinical Trials
337,297 Total Patients Enrolled
2 Trials studying Malnutrition
400 Patients Enrolled for Malnutrition
American Heart AssociationOTHER
344 Previous Clinical Trials
4,971,460 Total Patients Enrolled
2 Trials studying Malnutrition
284 Patients Enrolled for Malnutrition
Alexandra van den Berg, MPH, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
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