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

NCT06080425 | Recruiting

• 2 other identifiers: 25-02253048115811
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this feasibility study is to use family units as support to promote nutrition and physical activity of individuals with type 2 diabetes. The main question it aims to answer is:

• How does the family structure impact the health of its members living with type 2 diabetes? Participants will be asked to;
• Tell us about their access to food sources and places in the community to engage in physical activity.
• A nutrition and physical activity plan will be developed for participants and their families to use for 6 months.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

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

  This is a test that measures average blood sugar levels over the past 3 months

  baseline, 3 months, 6 months, 9 months and 12 months

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

  This is an indices used in the estimation of BMI

  baseline, 3 months, 6 months, 9 months and 12 months

Secondary Outcomes (4)

• Diabetes Knowledge

  baseline, 3 months, 6 months, 9 months and 12 months

• Diabetes self-management

  baseline, 3 months, 6 months, 9 months and 12 months

• Dietary Intake

  baseline, 3 months, 6 months, 9 months and 12 months

• Diabetes Distress

  baseline, 3 months, 6 months, 9 months and 12 months

Study Arms (1)

Medical Nutrition Therapy

OTHER

Medical Nutrition therapy is an intervention that will be administered to the participants for 6 months.

Behavioral: Medical Nutrition Therapy

Interventions

Medical Nutrition Therapy BEHAVIORAL

Counselling

Medical Nutrition Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• must be diagnosed with type 2 diabetes
• must be from rural Kentucky
• must be living in rural Kentucky for at least 1 year

You may not qualify if:

• potential participants without consent

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• American Diabetes Association: collaborator

Study Sites (1)

University of Texas Medical Branch, Galveston

Galveston, Texas, 77566, United States

RECRUITING

Related Publications (34)

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  PMID: 11194219 RESULT

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  PMID: 29729134 RESULT

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  RESULT

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  RESULT

• Smalls BL, Ortz CL, Barr-Porter M, Norman-Burgdolf H, McLouth CJ, Harlow B, Leshi O. Promoting Intergenerational Health in Rural Kentuckians With Diabetes (PIHRK'D): Protocol for a Longitudinal Cohort Study. JMIR Res Protoc. 2025 Jul 24;14:e69301. doi: 10.2196/69301.

  PMID: 40705414 DERIVED

Related Links

• America's Health Rankings. Kentucky Summary 2020.
• National Institute for Diabetes and Digestive and Kidney Diseases. (2016). Diabetes diet, eating, and physical activity
• State of Childhood Obesity. Kentucky Rates. 2020

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Brittany Smalls, PhD

  University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kindness Akwari

CONTACT

(409)772-1011; kcakwari@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monthly in-home MNT will be conducted by the RD for members of the household but will be tailored for the participant with diabetes for 6 months. Dietary counseling will be focused on living with diabetes, appropriate food choices, glycemic control, and importance of weight management. To enhance participant buy-in and sustainability, the RD will utilize Motivational Interviewing (MI) principles to work with participants to improve self-efficacy of behavior change and set Specific, Measurable, Achievable, Relevant, and Time-Bound (SMART) goals each month. Also, participants will enroll in the group facilitated Dining with Diabetes program with the option to bring one member of their social to their local Cooperative Extension offices. Dining with Diabetes is an interactive 4-session program that includes direct education on healthy eating, food preparation strategies, physical activity, emotional health, identifying complications of diabetes, and problem-solving skills.

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)