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Behavioral Intervention
Medically Tailored Groceries for Chronic Health Problems
N/A
Recruiting
Led By Kelseanna Hollis-Hansen, PhD, MPH
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >18 years
Be older than 18 years old
Must not have
Unwilling to participate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants participate for 4-months, study lasts 1-year
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to understand how a program that provides healthy food and coaching can help lower-income patients with chronic health problems like Type 2 diabetes and heart disease. The program offers free groceries tailored to the
Who is the study for?
This trial is for lower-income patients with chronic health issues like Type 2 diabetes or high blood pressure, who are treated at a safety-net clinic. Participants should be interested in improving their diet and willing to try new healthy eating habits.
What is being tested?
The study tests if providing medically tailored groceries and food resource coaching can improve diets of patients with chronic conditions. One group receives these tailored groceries and coaching, while the other gets regular free food without specific tailoring or coaching.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include adjustments in digestion or personal taste preferences as participants adapt to new eating patterns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not willing to participate in the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ participants participate for 4-months, study lasts 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants participate for 4-months, study lasts 1-year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence
Study feasibility (enrollment and retention)
Secondary study objectives
Diet quality
Nutrition security
Self-efficacy and knowledge around food procurement and healthy eating
Awards & 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: Medically tailored groceries and food resource coachingExperimental Treatment3 Interventions
Medically tailored groceries and food resource coaching.
Group II: Medically tailored groceriesExperimental Treatment2 Interventions
Medically tailored groceries only, no coaching.
Group III: Usual free community food market servicesActive Control1 Intervention
Usual free community food market services, no tailoring of food received.
Find a Location
Who is running the clinical trial?
Parkland Health and Hospital SystemOTHER
19 Previous Clinical Trials
99,075 Total Patients Enrolled
Crossroads Community ServicesUNKNOWN
University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,473 Total Patients Enrolled
American Heart AssociationOTHER
346 Previous Clinical Trials
4,970,977 Total Patients Enrolled
1 Trials studying Dyslipidemia
22 Patients Enrolled for Dyslipidemia
Kelseanna Hollis-Hansen, PhD, MPHPrincipal InvestigatorUT Southwestern Medical Center
2 Previous Clinical Trials
105 Total Patients Enrolled
Tammy Leonard, PhDPrincipal InvestigatorUT Southwestern Medical Center
Jaclyn Albin, MDPrincipal InvestigatorUT Southwestern Medical Center