Clinical trial NCT07023406: Effectiveness of and Implementation Strategies for 'Disfrutando'.
Official title: Effectiveness of and Implementation Strategies for 'Disfrutando': A Culturally Tailored, Bundled Intervention to Address Type 2 Diabetes Mellitus in High-burden Populations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Participatory Research
T2DM
High-Burden Populations
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, waitlisted, design
Primary purpose: PREVENTION

Brief summary: Despite much research that has focused on enhancing type 2 diabetes mellitus (T2DM) health outcomes for high burden populations, more remains to be done. There is a need to develop practical approaches that not only equip people with knowledge about T2DM self-management, but also help them mitigate the adverse social determinants of health (SDOH) that are fueling the burgeoning numbers of people in the United States with T2DM and that are preventing them from practicing healthful behaviors. This study will examine an intervention named 'Disfrutando' that strives to help people prevent and manage T2DM.

Detailed description: The investigators have engaged a community-health-academic partnership that is working to move a program of research forward that addresses the 'epidemic' of T2DM in high burden populations in Missouri. The partnership developed the Disfrutando intervention in a non-controlled feasibility study with encouraging results: Hemoglobin A1C (i.e., average blood sugar levels) was lowered for 66% of 31 participants. Disfrutando is an interactive, culturally tailored, bundled intervention that aims to enhance self-efficacy and equip people with knowledge and skills about healthful behaviors (i.e., healthy eating, physical activity) and engage them in primary/diabetes/eye care to enhance diabetes health outcomes. What makes Disfrutando stand out is its facilitation by community health workers who focus on "meeting people where they are" and connecting them to no- or low-cost resources that increase access to/engagement in healthy eating, physical activity, and primary/diabetes/eye care. The investigators now propose a 1-year pilot study that will examine the effectiveness of and implementation strategies for Disfrutando using a two-group randomized, wait-list controlled design. Hypotheses are: (1) implementation quality and acceptability of the Disfrutando intervention will be high and (2) the intervention will lower HbA1C, change body weight, enhance self-efficacy, and mitigate adverse SDOH. Research Questions are: RQ1: What is the implementation quality of the intervention? (i.e., adherence to intervention content, characteristics of intervention delivery), RQ2: Are people engaged and satisfied with the intervention?, RQ3: What is the impact of Disfrutando on HbA1C and change in body weight?, and RQ4: What is the relationship between HbA1C, change in body weight and selected mediators (diabetes self-efficacy, quality of intervention delivery, mitigation of SDOH (i.e., access and linkage to resources for engagement in healthy eating, physical activity, and attendance at health care appointments) and moderators (personal and health characteristics)? This pilot project will provide critical effectiveness and implementation data to inform an application for a multi-site community trial. Early identification and management of pre-diabetes and T2DM is critical for the prevention of diabetes-related serious health problems and premature death.

Eligibility criteria: Inclusion Criteria:

* Hemoglobin A1C of 5.7 or higher

Exclusion Criteria:

* Hemoglobin A1C of 5.6 or lower

Primary outcomes:
measure: Glucose (Blood Sugar) Control
timeFrame: Hemoglobin A1C will be measured at baseline (pre-intervention), 12 weeks, and 6 months.
Secondary outcomes:
measure: Change in Body Weight
timeFrame: Body weight will be measured weekly for 6 weeks, at 12 weeks, and at 6 months. The same scale will be used at all time points.
measure: Self-efficacy for diabetes self-care management
timeFrame: Self-efficacy will be measured at pre-intervention, 12 weeks, and 6 months
Other outcomes:
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