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

NCT ID: NCT05560386

Last Updated: 2023-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-03-31

Brief 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

Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Text messaging program

Enrolled participants received the pilot text messaging program.

Group Type: EXPERIMENTAL

Text messaging

Intervention Type: BEHAVIORAL

text messaging content to support diabetes prevention.

Virtual peer education

Enrolled participants received a virtual peer education diabetes prevention program.

Group Type: EXPERIMENTAL

Virtual workshop

Intervention Type: BEHAVIORAL

virtual workshop content to support diabetes prevention.

Interventions

Text messaging

text messaging content to support diabetes prevention.

Intervention Type: BEHAVIORAL

Virtual workshop

virtual workshop content to support diabetes prevention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

For Aim 1 (user interface testing):

• Ages 13-19 years;
• English speaking with English or Spanish speaking parent/guardian;
• Affiliated with East Harlem.

For Aim 2 (virtual workshop):

• Ages 13-19 years;
• English speaking with English or Spanish speaking parent/guardian;
• Affiliated with East Harlem;
• Overweight/obese based on measured body mass index;
• prediabetic based on hemoglobin A1c

Exclusion Criteria

• Medical or developmental conditions which would make it difficult to participate in a virtual group educational program

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Nita Vangeepuram

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nita Vangeepuram

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R03DK118302-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 17-2272

Identifier Type: -

Identifier Source: org_study_id