An interventional study of Medical Nutrition Therapy in Diabetes Mellitus, Type 2, sponsored by The University of Texas Medical Branch, Galveston. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Supportive care
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:
Participants will be asked to;
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 48 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Medical Nutrition therapy is an intervention that will be administered to the participants for 6 months.
Behavioral: Medical Nutrition Therapy
Counselling
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
Time frame: 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
Time frame: baseline, 3 months, 6 months, 9 months and 12 months
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.
Time frame: baseline, 3 months, 6 months, 9 months and 12 months
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).
Time frame: baseline, 3 months, 6 months, 9 months and 12 months
Dietary Intake
24-hour dietary will be used to estimate the dietary intake of the participants
Time frame: baseline, 3 months, 6 months, 9 months and 12 months
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)
Time frame: baseline, 3 months, 6 months, 9 months and 12 months
Plan to share: No — The participants have been informed that their personal data will not be shared, and their confidentiality will be kept.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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The University of Texas Medical Branch, Galveston