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"Go Healthy" Program for Diet-Related Diseases (ISA Trial)

N/A
Waitlist Available
Led By Valarie Jernigan, DrPH
Research Sponsored by Oklahoma State University Center for Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline and immediately post-intervention (16 weeks)
Awards & highlights

ISA Trial Summary

This trial will help Native Americans access healthy food and reduce diet-related diseases. It'll assess the effects, cost-effectiveness, and share findings with tribes to improve diet & health.

Who is the study for?
This trial is for Native American adults aged 18-75 with a BMI of 25 or higher, and children aged 3-17 living in Osage Nation. Participants should plan to stay in the area for the next year and be able to follow study procedures. Pregnant individuals or those planning pregnancy during the study are excluded.Check my eligibility
What is being tested?
The 'Go Healthy' program is being tested, which provides participants with weekly fresh produce, healthy recipes, and cooking materials. The study will assess its impact on diet, health outcomes like obesity and high blood pressure, and cost-effectiveness.See study design
What are the potential side effects?
Since this intervention involves dietary changes rather than medication, side effects may include adjustments to new foods or eating patterns but are not expected to be severe or medical in nature.

ISA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline and immediately post-intervention (16 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline and immediately post-intervention (16 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood pressure (adults only)
Diet using Healthy Eating Index scores
Glucose (adults only)
+4 more
Secondary outcome measures
BMI status using CDC guidelines
Food insecurity using the United States Department of Agriculture's Household Food Security Survey Module
HbA1c (adults only)
+2 more

ISA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: "Go Healthy" Intervention GroupExperimental Treatment1 Intervention
"Go Healthy" program
Group II: Wait-list Control GroupActive Control1 Intervention
Monetary compensation equal in value to the "Go Healthy" program

Find a Location

Who is running the clinical trial?

Washington State UniversityOTHER
102 Previous Clinical Trials
56,220 Total Patients Enrolled
Oklahoma State University Center for Health SciencesLead Sponsor
35 Previous Clinical Trials
4,676 Total Patients Enrolled
Osage NationUNKNOWN

Media Library

Go Healthy program Clinical Trial Eligibility Overview. Trial Name: NCT05773833 — N/A
Healthy Eating Research Study Groups: Wait-list Control Group, "Go Healthy" Intervention Group
Healthy Eating Clinical Trial 2023: Go Healthy program Highlights & Side Effects. Trial Name: NCT05773833 — N/A
Go Healthy program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05773833 — N/A
~0 spots leftby Jun 2024
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