Effectiveness of and Implementation Strategies for 'Disfrutando'.
ConditionType 2 Diabetes Mellitus (T2DM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri-Columbia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hemoglobin A1C of 5.7 or higher
Disqualifiers
Hemoglobin A1C of 5.6 or lower
Trial design
Design model
Parallel
Treatments tested in this trial
Disfrutando
BehavioralDisfrutando 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.
Treatment groups
31 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Waitlist GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Hemoglobin A1C will be measured at baseline (pre-intervention), 12 weeks, and 6 months.Secondary outcomes
1
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.
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.2
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.
Time frame
Self-efficacy will be measured at pre-intervention, 12 weeks, and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov