Type2 Diabetes Clinical Trial
— S4C - COVID-19Official title:
Stories for Change: Digital Storytelling Intervention for Diabetes Self-Management in the COVID-19 Pandemic
NCT number | NCT04738032 |
Other study ID # | 20-006354 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 26, 2020 |
Est. completion date | January 7, 2021 |
Verified date | February 2021 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Hispanic adults are twice as likely to have type 2 diabetes mellitus (T2D) and 1.5 times more likely to die from the disease than non-Hispanic whites. These disparities are mediated, in part, by less healthful levels of physical activity, dietary quality, medication adherence, and self-monitoring of blood glucose than non-Hispanic whites. Innovative approaches that arise from affected communities are needed to address these health disparities. Community-based participatory research (CBPR) has been successful in targeting health issues among Hispanic and immigrant populations; CBPR is an effective approach for addressing health behaviors in a sociocultural context. In 2004, the research team developed a CBPR partnership between immigrant communities and academic institutions called Rochester Healthy Community Partnership (RHCP) Storytelling or narrative-based interventions are designed to incorporate culture-centric health messaging to promote behavior change among vulnerable populations. Digital storytelling interventions are narrative-based videos elicited through a CBPR approach to surface the authentic voices of individuals overcoming obstacles toward engaging in health promoting behaviors to shape positive health behaviors of viewers through influences on attitudes and beliefs. RHCP partners from Hispanic communities identified T2D as a priority area for intervention, and have co-created each of the formative phases leading up to this proposal. Narrative theory and social cognitive theory formed the conceptual basis for intervention development. The study team conducted surveys and focus groups to derive the approach and personnel for building an authentic intervention that was created in a digital storytelling workshop where stories about diabetes self-management were captured, recorded, and edited to derive the final intervention products in video forma. The respective digital storytelling videos were pilot tested with 25 patients across healthcare institutions in Minnesota and Arizona. The intervention was rated as highly acceptable, culturally relevant, and perceived as efficacious for motivating behavioral change. The overall objective of this project is therefore to assess the efficacy of a digital storytelling intervention derived through a CBPR approach on self-management of T2D among Hispanic adults during a pandemic.
Status | Completed |
Enrollment | 76 |
Est. completion date | January 7, 2021 |
Est. primary completion date | January 7, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Self-identifies as Hispanic or Latino. - Between 18 and 70 years of age. - Participated in the parent study Exclusion Criteria: - Does not self-identifies as Hispanic or Latino. - Is not between 18 and 70 years of age. - Did not participated in the parent study |
Country | Name | City | State |
---|---|---|---|
United States | Hennepin Healthcare | Minneapolis | Minnesota |
United States | Mountain Park Health Center | Phoenix | Arizona |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | Hennepin Healthcare Research Institute, Mountain Park Health Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diabetes self-management behaviors | This is a brief survey instrument to assess the following domains: general diet, specific (diabetes) diet, physical activity, diabetes medication use, and blood glucose monitoring during the pandemic. | 5 months |
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