Promoting Intergenerational Health in Rural Kentuckians With Diabetes (PIHRK'D)
NCT ID: NCT06080425
Last Updated: 2025-12-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
75 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-09-01
Study Completion Date
2025-12-31
Brief Summary
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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.
• 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.
Detailed Description
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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.
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.
Conditions
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Diabetes Mellitus, Type 2
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
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.
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.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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Medical Nutrition Therapy
Medical Nutrition therapy is an intervention that will be administered to the participants for 6 months.
Group Type
OTHER
Medical Nutrition Therapy
Intervention Type
BEHAVIORAL
Counselling
Interventions
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Medical Nutrition Therapy
Counselling
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* must be from rural Kentucky
* must be living in rural Kentucky for at least 1 year
Exclusion Criteria
* potential participants without consent
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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American Diabetes Association
OTHER
Sponsor Role
collaborator
The University of Texas Medical Branch, Galveston
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Brittany Smalls, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Medical Branch, Galveston
Locations
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University of Texas Medical Branch, Galveston
Galveston, Texas, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Kindness Setser
Role: primary
References
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Reference Type
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.
Reference Type
DERIVED
Related Links
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https://www.niddk.nih.gov/health-information/diabetes/overview/diet-eating-physical-activity
National Institute for Diabetes and Digestive and Kidney Diseases. (2016). Diabetes diet, eating, and physical activity
https://stateofchildhoodobesity.org/state-data/?state=ky
State of Childhood Obesity. Kentucky Rates. 2020
Other Identifiers
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3048115811
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
25-0225
Identifier Type: -
Identifier Source: org_study_id