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

Diabetes Mellitus, Type 2 Clinical Trial

— PIHRK'D  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080425
• Other study ID #: 83972
• Secondary ID: 3048115811
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: University of Kentucky
• Contact: Oluwatosin Leshi, PhD
• Phone: 859-323-1719
• Email: tosin.leshi[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Description:

BACKGROUND Obesity is a notable public health problem: According to the Center for Disease Control, over 40% of the population in the United States suffers from obesity. Furthermore, obesity is the second leading cause of deaths in the United States and is associated with a significant increase in mortality and decrease in life expectancy of 5-10 years. Factors such as genetics, sedentary lifestyle, and diet have been shown to contribute to obesity. Specifically, the prevalence of obesity is remarkably higher or those living in rural communities (34.2%) than those living in urban communities (28.7%). In Kentucky, the impact of obesity is devastating, especially in rural communities. The overall state prevalence of obesity for adults in Kentucky is 36.6% and those rates can reach 46.6% in rural communities. Obesity and poor health outcomes among rural residents are related to unideal engagement in healthy lifestyle behaviors like nutritious eating and physical activity. Factors that contribute to the suboptimal lifestyle behaviors of residents in rural communities include limited personal and community resources and particular cultural norms and practices. The high rates of obesity are particularly of concern because of its association with an increased risk of cardiovascular disease, type 2 diabetes mellitus (T2DM), obstructive sleep apnea as well as cognitive function.

T2DM and obesity have a compounding effect on health disparities in rural communities in Kentucky: Type 2 diabetes mellitus (T2DM) is a persistent public health condition with 34.1 million U.S. adults affected. Moreover, geographic disparities exist with some population segments such as rural-dwelling Americans experience greater vulnerability to this condition. For instance, the prevalence of diagnosed T2DM is 17% higher in rural residents compared to their urban counterparts. The prevalence of T2DM in Kentucky's rural counties can reach 23%, compared to the overall state prevalence of 10.6%. Moreover, in Kentucky, obesity rates are among the highest in the nation with approximately 36.5% of adults classified as obese, 13.3% diagnosed with type 2 diabetes, 40.9% with hypertension, 37.9% with high cholesterol, while only 15.3% meet physical activity recommendations, and 4.7% meet fruit and vegetable consumption recommendations.

The burden of T2DM and obesity is evident across the lifespan: As obesity prevalence continues to increase in the US population, the effect of obesity has been focused on younger generations. Approximately 24% of adolescent ages 10 to 17 are classified as obese in Kentucky, placing the state number 1 in youth obesity. The increased prevalence of obesity can be associated with youth-onset T2DM indicated by a 95.3% increase from 2001 to 2017. Moreover, the prevalence of T2DM increases with age and an estimated 25% of older adults (≥ 65 years) have T2DM. The increased prevalence in T2DM among older adults is consistent with the increased prevalence of T2DM where an estimated one-third of older adults are obese. Even though residents in rural Kentucky communities are disproportionally affected by obesity and T2DM, with less access to health care and suboptimal environments, resulting in poorer health behaviors and outcomes. In addition, cultural norms and beliefs in these areas may further complicate these factors and their perception of the significance of preventative behaviors like health eating and physical activity in health outcomes.

The environment and behavior are possible contributors to intergenerational obesity and diabetes in rural Kentucky communities: The literature indicates that patterns of obesity can be seen within families. These patterns are thought to be due to the environments where people live, work, and play. Specifically, negative environmental factors (e.g., food deserts/healthy food options, lack of greenspace) that contribute to poor health choices (e.g., high food consumption, sweet beverages, lack of exercise). These environmental factors influence individuals' relationships with food within the family unit. Individuals raised in homes where unhealthy relationships with food have been developed are more likely to repeat these behaviors; thus, increasing the potential for weight gain and obesity throughout the lifespan. The confluence of behaviors and environment and their effect on gene expression, known as epigenetics, provides some explanation to obesity in certain populations. Similar to the patterns found for obesity, T2DM has been linked to genetics. Many of those living with T2DM have at least one family member who was also affected, exhibiting a pattern of inheritance. In addition, the risk of developing T2DM is 40% if one parent has T2DM and 70% if both parents have been diagnosed. Familial links to diabetes via certain genes/genetic factors and epigenetic changes have been noted. However, those changes are mostly attributed to the environment and individuals' behaviors. Specifically, T2DM has been linked to risk factors such as unhealthy eating, sedentary lifestyle, and stress. Though gene expression modifications occur via epigenetics, those changes can be reversible through environment and behavior modifications.

Family-based interventions can be used to promote health in rural communities: With an estimated 5.9 million intergenerational families (e.g., grandparents, parents, grandchildren ≤18 years), it is imperative that the understanding on how family structure impacts the health of its members is well explored. This type of family unit is particularly of interest in rural Appalachia since families provide influence cultural health beliefs and health behaviors. In addition to intergenerational households, families in rural Kentucky live on the same piece of land called hollows-land between two mountains. Family-centered behaviors have long-standing been shown to have positive, health-promoting benefits on nutrition and health outcomes. As disease management predominately occurs within the home, utilization of family-based interventions related to adult chronic diseases have been associated with positive health-related outcomes. Secure, supportive, relationships with individuals of support, including family or close friends, improve personal management of these conditions. Thus, developing an intervention that mitigates social environment factors that hinder proper nutrition and physical activity.

The burden of T2DM and obesity can be mitigated through common self-care activities, specifically healthy eating and physical activity: Healthy eating habits and physical activity are vital for those suffering from obesity and/or T2DM. There is strong evidence supporting the benefits in reducing long-term weight gain with healthy dietary patterns like consuming higher amounts of fruits and vegetables. Healthy eating habits are an important factor in T2DM prevention and management and can improve insulin sensitivity and glycemic control, which can help improve overall quality of life and lifestyle improvement. Physical activity is associated with numerous health benefits, specifically in reducing the risk of developing obesity and T2DM. An abundance of evidence from prospective cohort studies and randomized clinical trials indicate that physical activity and an active lifestyle are vital complements in weight management by increasing total energy expenditure, reducing fat mass, maintenance of lean body mass, and improving metabolic rate. The combination of increased physical activity and healthy eating has been shown to be more effective than either alone. Both nutritional changes and increased physical activity are factors contributing to weight loss, which is an important aspect of obesity and T2DM management to improve health outcomes and reduce long-term health complications. However, residents of rural Appalachian communities report inadequate diet and physical activity behaviors, and experience poorer health outcomes than the rest of the nation. Residents of rural Kentucky communities consistently report poor diet and low levels of physical activity as key health concerns, and data has shown that it is less common for residents living in rural areas to consume the recommended weekly servings of fruits and vegetables compared to nonrural residents.

APPROACH 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 participants' placement within the Transtheoretical Model (Six Stages of Change): pre-contemplation, contemplation, preparation, action, maintenance, or relapse. 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 a 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 feasibility of the proposed intervention, the investigators will use guiding question that address the following: evaluation of recruitment capability and resulting sample characteristics, evaluation and refinement of data collection procedures and outcomes 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Medical Nutrition Therapy
Counselling

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Kentucky	American Diabetes Association

Country where clinical trial is conducted

United States, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	baseline, 3 months, 6 months, 9 months and 12 months
Secondary	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).	baseline, 3 months, 6 months, 9 months and 12 months
Secondary	Dietary Intake	24-hour dietary will be used to estimate the dietary intake of the participants	baseline, 3 months, 6 months, 9 months and 12 months
Secondary	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)	baseline, 3 months, 6 months, 9 months and 12 months

External Links

•   America's Health Rankings. Kentucky Summary 2020.
•   Centers for Disease Control and Prevention. National diabetes statistics report 2020: Estimates of diabetes and its burden in the United States. 2020.
•   National Institute for Diabetes and Digestive and Kidney Diseases. (2016). Diabetes diet, eating, and physical activity
•   State of Childhood Obesity. Kentucky Rates. 2020