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Behavioural Intervention

Nutrition Education + Food Resources for Type 2 Diabetes

N/A
Recruiting
Led By Sarah Stotz, PhD
Research Sponsored by Colorado State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of type 2 diabetes
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 3 months (2 * 24 hour recalls at each timepoint = 4 * 24 hour recalls per participant)
Awards & highlights

Study Summary

This trial seeks to improve diabetes management for AI/ANs by combining diabetes nutrition education with added food security resources like farmers market vouchers. Outcomes of the 3-month intervention will be measured.

Who is the study for?
This trial is for American Indian and Alaska Native adults who have type 2 diabetes, can speak English fluently, and plan to stay in the area during the study. It's not for those who might move away during the trial period.Check my eligibility
What is being tested?
The study tests if diabetes nutrition education classes combined with a food security resource like farmers market vouchers improve diabetes management in AI/ANs. Participants are divided into three groups: one gets both resources, another only education, and the last group just the vouchers.See study design
What are the potential side effects?
Since this trial involves educational classes and access to healthy foods rather than medication, there are no typical drug side effects; however, changes in diet may cause digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with type 2 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 3 months (2 * 24 hour recalls at each timepoint = 4 * 24 hour recalls per participant)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 3 months (2 * 24 hour recalls at each timepoint = 4 * 24 hour recalls per participant) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemoglobin A1c
Secondary outcome measures
Blood pressure
Body weight
Diabetes distress
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: What Can I Eat Diabetes Nutrition Education Classes OnlyExperimental Treatment1 Intervention
Participants will be enrolled in a 3 month, 5 session in-person diabetes nutrition education class, entitled What Can I Eat?, over the course of the 3 month intervention (4 * 90 min in person classes weekly for a month, with 5th class at 3 months from baseline).
Group II: What Can I Eat Diabetes Nutrition Education Classes + Healthy Food Security ResourceExperimental Treatment2 Interventions
Participants will be enrolled in a 3 month, 5 session in-person diabetes nutrition education class, entitled What Can I Eat?, over the course of the 3 month intervention (4 * 90 min in person classes weekly for a month, with 5th class at 3 months from baseline). Additionally, patients will receive a $30.00 healthy food resource weekly for 12 weeks.
Group III: Healthy Food Security Resource OnlyExperimental Treatment1 Intervention
Patients will receive a $30.00 healthy food resource weekly for 12 weeks.

Find a Location

Who is running the clinical trial?

Colorado State UniversityLead Sponsor
125 Previous Clinical Trials
38,259 Total Patients Enrolled
American Diabetes AssociationOTHER
139 Previous Clinical Trials
99,506 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,492 Total Patients Enrolled

Frequently Asked Questions

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

Is registration for this trial currently open?

"Affirmative. The clinical trial is actively recruiting, as per the information found on clinicaltrials.gov; it was first posted on September 1st 2023 and last edited October 5th of that same year. At this time, they are looking for 100 participants at a single site."

Answered by AI

How many total participants is the clinical trial accommodating?

"Affirmative. According to the information available on clinicaltrials.gov, this clinical trial is recruiting participants at present and was first posted on September 1st 2023 with its most recent update occurring October 5th of the same year. The enrolment goal for this trial sits at 100 subjects across one site."

Answered by AI

Who else is applying?

What site did they apply to?
Oklahoma City Indian Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D
2023. "Diabetes Nutrition Education and Healthy Food Resource for AIANs With T2D". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077162.
~67 spots leftby Nov 2025
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