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

January 7, 2026 updated by: The University of Texas Medical Branch, Galveston

Addressing Intergenerational Obesity and Promoting Healthy Eating and Physical Activity Among Individuals [PIHRK'D] Living With Diabetes in Rural Kentucky

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The proposed project is informed by the National Framework for Health Equity and Well Being, which was recently developed by the Cooperative Extension Service. This framework explicitly acknowledges the multiple levels of influence on health outcomes and the role of Cooperative Extension Service as a mitigator of community-level health inequities. The framework acknowledges factors that contribute to health inequities at various societal levels, including root causes of structural inequity; norms, policies, and practices; and social determinants of health. As individuals flow through multiple sectors of the environment, each is known to have a direct influence individually and collectively. For the proposed grant, the study will focus on how county-level Extension agents (federally funded program) can be used to mitigate health disparities that contribute to intergenerational obesity and T2DM management in rural Kentucky. Community-level factors also impact health outcomes, such as lack of access to healthy, affordable food, as well as availability of health-related resources. Community assets will be gathered using subjective and objective community audits and assessed at the participant level using social network analysis. Societal-level factors include social norms and cultural health beliefs that impact health decision-making within the community, particularly families/households.

Participants will be recruited on a staggered basis from 2 rural counties in Kentucky. Recruitment will be conducted via Extension Offices, word-of-mouth, social media, UK Healthcare outpatient clinics (e.g., internal medicine, family medicine, endocrinology), as well as UK's Barnstable Brown Diabetes and Obesity Center. Once enrolled, participants will be screened by the RD to confirm obesity/overweight, T2DM diagnosis, and identify each participant's placement within the Transtheoretical Model (Six Stages of Change): pre-contemplation, contemplation, preparation, action, maintenance, or relapse. The enrollment stage of change will be used to develop appropriate goals for each participant. Beyond the primary enrolled participant in the study, members of the household will be invited to attend meetings with the RD and Dining with Diabetes program sessions.

Aim 1: Use social network analysis to describe (a) community assets (e.g., access to healthy eating and ways to participate in physical activity) and (b) intergenerational links to obesity and diabetes (e.g., parent, sibling, child).

Social network analysis will be used to map food sources and food assistance (e.g., supermarket, convenience store, fast food, food pantries), including the types of food offered and frequency of engagement with food sources. Similar methods will be used to identify areas/places within the community that could be used to engage in physical activities (e.g., gym, community center, green space, walking trails). A network map will be developed per household to be used to develop a tailored program that that is feasible and accessible to overweight/obese individuals living with diabetes and members of their household.

Participants will be asked to provide the following information on up to 5 immediate family members: age; sex; education level; relationship (e.g., spouse, child, sibling, parent); whether that individual is overweight/obese; and current T2DM diagnosis status (e.g., no diagnosis, diagnosed by a healthcare provider, told by a healthcare provider to be prediabetic). Additional information will be gathered regarding the interconnectedness (e.g., person 1 and person 3 are siblings) of the known relationships between family members.

Aim 2: Develop a household-specific nutrition and physical activity plan. A 6-month nutrition and physical activity intervention will be implemented with eligible, enrolled Kentucky residents focused on leveraging household/familial social networks. Medical nutrition therapy will be used within a household to tailor healthy eating and physical activity. The 4-week Dining with Diabetes Program will be used to supplement medical nutrition therapy. The participant will be engaged to take someone from their household with them to the Dining with Diabetes sessions to promote and reinforce healthy lifestyle choices.

At the baseline study visit, the research coordinator will provide a study overview and conduct consent. After consent has been obtained, the research coordinator will collect demographics, baseline clinical outcomes, validated surveys, and social network data for the perceived community resources and family characteristics. The research coordinator will conduct an objective community assessment and provide that information as well as the perceived community assets data to the dietitian to be used as part of the medical nutrition therapy. The research coordinator will collect relevant clinical measures, specifically blood pressure, HbA1c, and lipid panel, and validated surveys at baseline and 3 and 6 months post-intervention. The dietitian will schedule and complete the first session medical nutrition therapy within 2 weeks of baseline data collection and will continue to conduct medical nutrition therapy monthly for 6 months. The dietitian will also collect relevant clinical measures, specifically blood pressure, HbA1c, and lipid panel, and validated surveys at 3 and 6 months during the intervention period.

Aim 3: Determine the preliminary effectiveness of tailored nutrition and physical activity for those living within the household.

Data will be collected at five times per participant throughout the intervention. Data collection time points will include baseline and twice during the 6 months intervention period (3 and 6 months) and then again at 3 months and 6 months post-intervention.

To evaluate the feasibility of the proposed intervention, the investigators will use guiding questions that address the following: evaluation of recruitment capability and resulting sample characteristics, evaluation and refinement of data collection procedures and outcome measures, evaluation of acceptability and suitability of intervention and study procedures, evaluation of resources and ability to manage and implement the study and intervention, and preliminary evaluation of participant responses to interventions. Acceptability of community health workers will be assessed using a previously published assessment of community health workers. This assessment measures attributes, such as the participants' perception of cooperative extension agents and a registered dietician to address health concerns, respect and dignity, honesty, interpersonal relationships, and assistance with changing behaviors.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77566
        • Recruiting
        • University of Texas Medical Branch, Galveston
        • Contact:
        • Principal Investigator:
          • Brittany L. Smalls, PhD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • potential participants without consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Medical Nutrition Therapy
Medical Nutrition therapy is an intervention that will be administered to the participants for 6 months.
Behavioral: Medical Nutrition Therapy
Counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemoglobin A1c values measured at the five post-baseline follow-up points
Time Frame: baseline, 3 months, 6 months, 9 months and 12 months
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
Time Frame: baseline, 3 months, 6 months, 9 months and 12 months
This is an indices used in the estimation of BMI
baseline, 3 months, 6 months, 9 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary Intake
Time Frame: baseline, 3 months, 6 months, 9 months and 12 months
24-hour dietary will be used to estimate the dietary intake of the participants
baseline, 3 months, 6 months, 9 months and 12 months
Diabetes Distress
Time Frame: baseline, 3 months, 6 months, 9 months and 12 months
The Diabetes Distress Scale (DDS) is a 17-item scale that measures patient concerns about disease management, support, emotional burden and access to care. The response scale for each question ranges from "1" (not a problem) to "6" (a very serious problem). An average score of greater than or equal to 3 indicated moderate distress and discriminated between high and low distressed groups (Fisher et al, 2008)
baseline, 3 months, 6 months, 9 months and 12 months
Diabetes Knowledge
Time Frame: baseline, 3 months, 6 months, 9 months and 12 months
Diabetes knowledge of the participants will be assessed using a validated Diabetes Knowledge Questionnaire (DKQ). The DKQ is a 24-item questionnaire, designed by Starr County Diabetes Education Study, to elicit information about patients' understanding of the cause of their disease, its associated complications, blood glucose levels, diet, and physical activity. The DKQ has three response options "yes", "no", and "don't know". One point is awarded for each correct option, whereas, no point or negative scoring for the incorrect option. Its scoring involves summing-up the points obtained by each participant. A higher score represents better disease knowledge.
baseline, 3 months, 6 months, 9 months and 12 months
Diabetes self-management
Time Frame: baseline, 3 months, 6 months, 9 months and 12 months

Diabetes self-management/self-efficacy will be assessed using the Diabetes Empowerment Scale. Diabetes Empowerment Scale is a 28-item scale that measures diabetes-related psychosocial self-efficacy with an overall Cronbach's uses 3 subscales: Managing the Psychosocial Aspects of Diabetes, Assessing Dissatisfaction and Readiness to Change, and Setting and Achieving Diabetes Goals (Anderson et al, 2000).

The questionnaires consist of 28 items with 3 subscales, with each item rated along a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). The range of score is divided in three subgroups as low (28-65 scores), middle (66-103) and high (104-140).
baseline, 3 months, 6 months, 9 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Brittany Smalls, PhD, University of Texas Medical Branch, Galveston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-0225
  • 3048115811 (Other Grant/Funding Number: American Diabetes Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The participants have been informed that their personal data will not be shared, and their confidentiality will be kept.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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