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Behavioral Intervention
Medical Nutrition Therapy for Type 2 Diabetes (PIHRK'D Trial)
N/A
Recruiting
Led By Brittany Smalls, PhD
Research Sponsored by University of Kentucky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with type 2 diabetes
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 9 months and 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate if using family units to promote nutrition and physical activity can help people with type 2 diabetes improve their health.
Who is the study for?
This trial is for individuals with type 2 diabetes who live in rural Kentucky and have been residents for at least a year. It's designed to explore how family support can improve nutrition and physical activity habits. Participants must be diagnosed with type 2 diabetes and willing to consent.
What is being tested?
The study tests Medical Nutrition Therapy, focusing on the role of family structures in managing health through diet and exercise plans tailored for diabetic patients and their families over six months.
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects are not typical as seen with drugs. However, participants may experience challenges adjusting to new dietary or physical activity routines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with type 2 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months, 9 months and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, 9 months and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
body weight measured at the five post-baseline follow-up points
hemoglobin A1c values measured at the five post-baseline follow-up points
Secondary study objectives
Diabetes Distress
Diabetes Knowledge
Diabetes self-management
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Medical Nutrition TherapyExperimental Treatment1 Intervention
Medical Nutrition therapy is an intervention that will be administered to the participants for 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medical Nutrition Therapy
2015
N/A
~50
Find a Location
Who is running the clinical trial?
University of KentuckyLead Sponsor
194 Previous Clinical Trials
223,650 Total Patients Enrolled
American Diabetes AssociationOTHER
146 Previous Clinical Trials
101,604 Total Patients Enrolled
Brittany Smalls, PhDPrincipal InvestigatorUniversity of Kentucky
2 Previous Clinical Trials
184 Total Patients Enrolled