Effectiveness of and Implementation Strategies for 'Disfrutando'.

NCT07023406 | Recruiting DMC

• 1 other identifier: 0082846
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Participatory Research; T2DM; High-Burden Populations

Outcome Measures

Primary Outcomes (1)

• Glucose (Blood Sugar) Control

  Name of measurement: Hemoglobin A1c (HbA1C) How measured/assessed: HbA1C is a biomedical test that provides average glucose (blood sugar) level over the past 8 to 12 weeks and is used to help manage diabetes. Glucose (blood sugar) control will be evaluated using the A1CNow Self Check device. This FDA-cleared device is sold over the counter and is a portable, self-check test that is self-administered using a small fingerstick blood sample. Results are obtained in 5 minutes.

  Hemoglobin A1C will be measured at baseline (pre-intervention), 12 weeks, and 6 months.

Secondary Outcomes (2)

• Change in Body Weight

  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.

• Self-efficacy for diabetes self-care management

  Self-efficacy will be measured at pre-intervention, 12 weeks, and 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral Intervention

Behavioral: Disfrutando

Waitlist Group

EXPERIMENTAL

This arm will receive the intervention after the waitlist period

Behavioral: Disfrutando

Interventions

Disfrutando BEHAVIORAL

Disfrutando is a six-week, weekly intervention with a booster intervention at week 12. Intervention content includes glucose control with individual goals, glucose monitoring and glucometer practice, healthy eating demonstrations, benefits of physical activity, prevention and management of T2DM. The intervention has a strong focus on mitigating barriers and challenges to diabetes self-care management.

Intervention Group; Waitlist Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemoglobin A1C of 5.7 or higher

You may not qualify if:

• Hemoglobin A1C of 5.6 or lower

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (2)

University of Missouri

Columbia, Missouri, 65211, United States

RECRUITING

Holy Cross Church

Kansas City, Missouri, 64123, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Maithe Enriquez, PhD

CONTACT

18166863242; enriquezm@missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Nursing

Model Details: Randomized, controlled, waitlisted, design

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 17, 2025
• Study Start: August 1, 2025
• Primary Completion: May 15, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 7, 2026

Record last verified: 2025-06

Locations

US (2)