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Diabetes Mellitus, Type 2PIHRK'DNCT06080425

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

A study testing Medical Nutrition Therapy in people with Diabetes Mellitus, Type 2, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Medical Nutrition Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
1 Sep 2023to 28 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • potential participants without consent

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Texas Medical Branch, Galveston

    Galveston, Texas, 77566

Other trials in United States

About this study

Official title: 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.
Read the 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.

Being tested
Medical Nutrition Therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical Nutrition TherapyBehavioural

    Counselling

Study groups in NCT06080425
Study groupRoleWhat they receive
Medical Nutrition TherapyOtherMedical Nutrition therapy is an intervention that will be administered to the participants for 6 months.
Receives: Behavioral: Medical Nutrition Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

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

    This is an indices used in the estimation of BMI

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

Secondary outcomes (4)
  1. Diabetes Knowledge

    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.

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

  2. Diabetes self-management

    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).

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

  3. Dietary Intake

    24-hour dietary will be used to estimate the dietary intake of the participants

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

  4. Diabetes Distress

    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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start1 Sep 2023
  3. Primary completion25 Feb 2026
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06080425
Sponsor's protocol ID
25-0225
Other IDs
3048115811
Acronym
PIHRK'D
Status last verified
Aug 2026
First submitted
6 Oct 2023
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The participants have been informed that their personal data will not be shared, and their confidentiality will be kept.

Publications

  • Albuquerque D, Nobrega C, Manco L, Padez C. The contribution of genetics and environment to obesity. Br Med Bull. 2017 Sep 1;123(1):159-173. doi: 10.1093/bmb/ldx022.

    PubMed 28910990
  • Ali O. Genetics of type 2 diabetes. World J Diabetes. 2013 Aug 15;4(4):114-23. doi: 10.4239/wjd.v4.i4.114.

    PubMed 23961321
  • Anders S, Schroeter C. Diabetes, diet-health behavior, and obesity. Front Endocrinol (Lausanne). 2015 Mar 16;6:33. doi: 10.3389/fendo.2015.00033. eCollection 2015.

    PubMed 25852643
  • Anderson RM, Funnell MM, Fitzgerald JT, Marrero DG. The Diabetes Empowerment Scale: a measure of psychosocial self-efficacy. Diabetes Care. 2000 Jun;23(6):739-43. doi: 10.2337/diacare.23.6.739.

    PubMed 10840988
  • Baig AA, Benitez A, Quinn MT, Burnet DL. Family interventions to improve diabetes outcomes for adults. Ann N Y Acad Sci. 2015 Sep;1353(1):89-112. doi: 10.1111/nyas.12844. Epub 2015 Aug 6.

    PubMed 26250784
  • Benjamini Y., Hochberg Y. (1995). Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing. Journal of the Royal Statistical Society. Series B (Methodological), 57(1), 289-300

  • Bhupathiraju SN, Hu FB. Epidemiology of Obesity and Diabetes and Their Cardiovascular Complications. Circ Res. 2016 May 27;118(11):1723-35. doi: 10.1161/CIRCRESAHA.115.306825.

    PubMed 27230638
  • Chapman-Novakofski K, Karduck J. Improvement in knowledge, social cognitive theory variables, and movement through stages of change after a community-based diabetes education program. J Am Diet Assoc. 2005 Oct;105(10):1613-6. doi: 10.1016/j.jada.2005.07.010.

    PubMed 16183364
  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PubMed 12900694
  • Demir D, Bektas M. The effect of childrens' eating behaviors and parental feeding style on childhood obesity. Eat Behav. 2017 Aug;26:137-142. doi: 10.1016/j.eatbeh.2017.03.004. Epub 2017 Mar 22.

    PubMed 28363115
  • Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.

    PubMed 18474888
  • Fruh SM. Obesity: Risk factors, complications, and strategies for sustainable long-term weight management. J Am Assoc Nurse Pract. 2017 Oct;29(S1):S3-S14. doi: 10.1002/2327-6924.12510.

    PubMed 29024553
  • Garcia AA, Villagomez ET, Brown SA, Kouzekanani K, Hanis CL. The Starr County Diabetes Education Study: development of the Spanish-language diabetes knowledge questionnaire. Diabetes Care. 2001 Jan;24(1):16-21. doi: 10.2337/diacare.24.1.16.

    PubMed 11194219
  • Griffie D, James L, Goetz S, Balotti B, Shr YH, Corbin M, Kelsey TW. Outcomes and Economic Benefits of Penn State Extension's Dining With Diabetes Program. Prev Chronic Dis. 2018 May 3;15:E50. doi: 10.5888/pcd15.170407.

    PubMed 29729134
  • Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8.

    PubMed 32487284

Questions about this trial

What is this clinical trial studying?

A study testing Medical Nutrition Therapy in people with Diabetes Mellitus, Type 2, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hemoglobin A1c values measured at the five post-baseline follow-up points (time frame: baseline, 3 months, 6 months, 9 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06080425, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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