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

Mount Sinai Health System logo

Mount Sinai Health System

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Behavioral: Virtual workshop
Behavioral: Text messaging

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05560386
GCO 17-2272
5R03DK118302-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

13 to 19 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

Text messaging program
Experimental group
Description:
Enrolled participants received the pilot text messaging program.
Treatment:
Behavioral: Text messaging
Virtual peer education
Experimental group
Description:
Enrolled participants received a virtual peer education diabetes prevention program.
Treatment:
Behavioral: Virtual workshop

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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