Clinical Trials Directory

Trials / Completed

CompletedNCT05560386

TEEN HEED: An Adolescent Diabetes Prevention Intervention Incorporating Novel Mobile Health Technologies

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
54 (actual)
Sponsor
Icahn School of Medicine at Mount Sinai · Academic / Other
Sex
All
Age
13 Years – 19 Years
Healthy volunteers
Not accepted

Summary

The number of youth with type 2 diabetes in the U.S. is projected to increase by a staggering 49 percent by 2050, with higher rates among minority youth. The Diabetes Prevention Program (DPP) is recognized as a sentinel study demonstrating the effectiveness of lifestyle interventions for diabetes prevention among pre-diabetic adults but has not yet been replicated in youth. In addition, such intensive interventions are often not sustainable in high risk communities with limited resources. One strategy that has been successfully employed in adults from such communities is peer based health education. However, there have been no peer led interventions in ethnic minority teens and no interventions focused specifically on weight loss for diabetes prevention. Another challenge identified in existing youth health intervention programs is keeping youth engaged to enhance program participation and impact. One potential strategy is the use of mobile technologies (text messaging, mobile applications, social media) to support weight management programs, but to date use of such technologies has largely not been studied in youth. The Principal Investigator's NIH Mentored Patient-Oriented Research Career Development Award (K23) aimed to use CBPR to develop and pilot test a peer-led diabetes prevention intervention incorporating mobile health technologies for at-risk adolescents. Based on results of focus groups which explored strategies for using peer educators and mHealth tools as part of a group lifestyle change program, the researchers did not find existing tools with all the features and functionalities required by users. The investigators therefore began working with teen stakeholders to create a new text messaging platform to support participants as the teens complete the intervention. This R03 research proposal aims to bring together clinical, technology and community experts to further develop and evaluate the mobile health platform. This will provide important pilot data to refine and disseminate the intervention for a larger RCT to be tested in a future R01. Specific Aims: 1. Synthesize real-time data and analytics and conduct user interface (UI) testing to refine and enhance features of the prototype text messaging platform. 2. Investigate the potential for the developed platform to be used as an adjunct to a group educational intervention by examining whether level of use, user satisfaction, and degree of engagement with the platforms modifies behavioral and clinical outcomes.

Conditions

Interventions

TypeNameDescription
BEHAVIORALText messagingtext messaging content to support diabetes prevention.
BEHAVIORALVirtual workshopvirtual workshop content to support diabetes prevention.

Timeline

Start date
2020-08-01
Primary completion
2022-03-31
Completion
2022-03-31
First posted
2022-09-29
Last updated
2023-12-29
Results posted
2023-12-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05560386. Inclusion in this directory is not an endorsement.