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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

PIHRK'D Trial 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.Check my eligibility

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.See study design

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.

PIHRK'D Trial 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.

PIHRK'D Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 9 months and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

body weight measured at the five post-baseline follow-up points

hemoglobin A1c values measured at the five post-baseline follow-up points

Secondary outcome measures

Diabetes Distress

Diabetes Knowledge

Diabetes self-management

+1 more

PIHRK'D 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of KentuckyLead Sponsor

186 Previous Clinical Trials

226,609 Total Patients Enrolled

American Diabetes AssociationOTHER

139 Previous Clinical Trials

99,531 Total Patients Enrolled

Brittany Smalls, PhDPrincipal InvestigatorUniversity of Kentucky

2 Previous Clinical Trials

191 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 recruitment still open for this investigation?

"According to the clinicaltrials.gov listing, this trial is presently searching for participants. The experiment was initially advertised on September 1st 2023 with a subsequent update on October 6th of the same year."

Answered by AI

How many participants are currently engaged in this research study?

"Affirmative, clinicaltrials.gov lists this trial as accepting participants at the present time. This investigation was initially made available on September 1st of 2023 and has since been revised six weeks later. The study is accommodating seventy-five people over a single site."

Answered by AI

What are the main goals this clinical trial is seeking to accomplish?

"This trial intends to observe body weight at 5 post-baseline follow up points. Secondary objectives include a Diabetes self-management assessment, a 24-hour dietary intake survey and the evaluation of patient diabetes distress using the 17 item Diabetes Distress Scale (DDS). The DDS response scale ranges from 1 (not a problem) to 6 (a very serious problem), with an average score above 3 indicating moderate levels of distress."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Promoting Intergenerational Health in Rural Kentuckians With Diabetes (PIHRK'D)

Brittany L Smalls 2023. "Promoting Intergenerational Health in Rural Kentuckians With Diabetes (PIHRK'D)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06080425.