Type 2 Diabetes Mellitus (T2DM)Disfrutando 2NCT07023406
Effectiveness of and Implementation Strategies for 'Disfrutando'.
A study testing Disfrutando in people with Type 2 Diabetes Mellitus (T2DM), run by University of Missouri-Columbia at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Disfrutando
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2025to 31 May 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
- Hemoglobin A1C of 5.7 or higher
Who cannot join
- Hemoglobin A1C of 5.6 or lower
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Missouri
Columbia, Missouri, 65211
Holy Cross Church
Kansas City, Missouri, 64123
About this study
Official title: Effectiveness of and Implementation Strategies for 'Disfrutando': A Culturally Tailored, Bundled Intervention to Address Type 2 Diabetes Mellitus in High-burden Populations
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Disfrutando
- Keywords
- Participatory Research, T2DM, High-Burden Populations
- 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.
DisfrutandoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Behavioral Intervention Receives: Behavioral: Disfrutando |
| Waitlist Group | Experimental | This arm will receive the intervention after the waitlist period Receives: Behavioral: Disfrutando |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hemoglobin A1C will be measured at baseline (pre-intervention), 12 weeks, and 6 months.
Secondary outcomes (2)
Change in Body Weight
Name of Measurement: Change in Body Weight. How measured/assessed: weight will be measured using a medical-grade scale. Weight is a modifiable contributor to type 2 diabetes mellitus (T2DM), and addressing overweight can enhance T2DM health outcomes.
Measured: 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
Name of measurement: Diabetes Self-Efficacy Scale. How measured/assessed: Self-efficacy is hypothesized as a mediator of engagement in healthful diabetes-related behaviors. Self-efficacy (i.e., confidence that an individual has for managing their diabetes) will be measured with the Diabetes Self-Efficacy Scale, a questionnaire with 8 questions that was developed by the Stanford Patient Education Center. The questionnaire uses a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident) in the ability to perform activities to manage diabetes, such as diet, exercise, and following up with healthcare providers.
Measured: Self-efficacy will be measured at pre-intervention, 12 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Aug 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, waitlisted, design
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maithe Enriquez, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023406
- Sponsor's protocol ID
- 0082846
- Acronym
- Disfrutando 2
- Status last verified
- Jul 2026
- First submitted
- 29 May 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of and Implementation Strategies for 'Disfrutando': A Culturally Tailored, Bundled Intervention to Address Type 2 Diabetes Mellitus in High-burden Populations
- ClinicalTrials.gov ID
- NCT07023406
- Acronym / sponsor ID
- Disfrutando 2 / 0082846
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Participatory Research, T2DM, High-Burden Populations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, waitlisted, design
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: DisfrutandoBehavioral Intervention |
| Waitlist Group | Experimental | Behavioral: DisfrutandoThis arm will receive the intervention after the waitlist period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hemoglobin A1C of 5.7 or higher
Key exclusion criteria (1 listed)
- Hemoglobin A1C of 5.6 or lower
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DisfrutandoDisfrutando 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. | Behavioural | Intervention Group, Waitlist Group |
Primary outcome
Glucose (Blood Sugar) Control
Time frame: Hemoglobin A1C will be measured at baseline (pre-intervention), 12 weeks, and 6 months.
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.
2 secondary outcomes
Change in Body Weight
Time frame: 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
Time frame: Self-efficacy will be measured at pre-intervention, 12 weeks, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disfrutando in people with Type 2 Diabetes Mellitus (T2DM), run by University of Missouri-Columbia at 2 sites 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 1 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Glucose (Blood Sugar) Control (time frame: Hemoglobin A1C will be measured at baseline (pre-intervention), 12 weeks, and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.