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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline and immediately post-intervention (16 weeks)

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington State UniversityOTHER

101 Previous Clinical Trials

56,134 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there age restrictions for participating in this scientific investigation?

"This trial's enrolment is restricted to 3-75 year old participants. There are 76 studies that cater exclusively towards minors, while 353 have been designed with the elderly in mind."

Answered by AI

Are there still opportunities to participate in this experiment?

"According to the clinicaltrials.gov website, this research trial is seeking participants and was first made available on February 22nd 2023 with its most recent edit taking place on March 6th of that same year."

Answered by AI

Am I allowed to join this medical experiment?

"To be considered, an individual must suffer from food insecurity and fall within the age range of 3 to 75 years. 400 participants are being recruited for this trial."

Answered by AI

How many participants will be included in this experiment?

"Affirmative. The clinicaltrials.gov website states that the trial is actively searching for participants, and was first published on February 22nd 2023 with its last edit being made on March 6th of the same year. 400 people are required to be enrolled from a single location for this research venture."

Answered by AI

What are the desired results of this research endeavor?

"The primary outcome of this study, evaluated over a 16 week period, will be the change in blood pressure among adults. Secondary outcomes include changes in HbA1c levels and household food security using the United States Department of Agriculture's Household Food Security Survey Module which consists of 18 questions to gauge qualitative and quantitative aspects related to food supply within households across America. Additionally, overall health status is measured with the Short Form-36 scale that features five answer options ranging from excellent to poor."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Indigenous Supported Agriculture "Go Healthy"

2023. "Indigenous Supported Agriculture "Go Healthy"". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05773833.