Viewing Study NCT04266054



Ignite Creation Date: 2024-05-06 @ 2:15 PM
Last Modification Date: 2024-10-26 @ 1:28 PM
Study NCT ID: NCT04266054
Status: COMPLETED
Last Update Posted: 2024-07-05
First Post: 2020-02-10

Brief Title: Stories for Change Digital Storytelling for Diabetes Self-Management Among Somali Adults
Sponsor: Mayo Clinic
Organization: Mayo Clinic

Study Overview

Official Title: Stories for Change Digital Storytelling for Diabetes Self-Management Among Somali Adults
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: S4C
Brief Summary: Somali adults are more likely to have type 2 diabetes mellitus T2D and more likely to die from the disease than non-Somali 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-Somali 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 Somali 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 Somali 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 format The respective digital storytelling videos will be pilot tested with 80 patients in Rochester MN In a mirror project for Hispanic adults 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 Somali adults
Detailed Description: The study team will conduct a two-group randomized controlled trial in a primary care clinical setting at Mayo Clinic in Rochester MN with Somali adults with poorly controlled T2D hemoglobin A1c8 The intervention group will view the 12-minute digital storytelling video Both the intervention and comparison groups will receive diabetes education and resource cards as well as usual clinical care The primary outcome will be glycemic control as measured by hemoglobin A1c 3 months after intervention delivery Secondary outcomes will include diabetes self-management behaviors blood pressure LDL-cholesterol and body mass index The impact of concomitant covariates including sex age and socio-economic status on the sensitivity of the intervention effect will also be explored

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None