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

NCT05560386 | Completed Results

• 2 other identifiers: GCO 17-22725R03DK118302-02
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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. 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. 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

Outcome Measures

Primary Outcomes (2)

• Body Mass Index (BMI)

  Maintenance or reduction of BMI after completion of the virtual diabetes prevention program. BMI is a person's weight in kilograms divided by the square of height in meters. A high BMI can indicate high body fatness and may lead to health problems.

  baseline

• Body Mass Index (BMI)

  Maintenance or reduction of BMI after completion of the virtual diabetes prevention program. BMI is a person's weight in kilograms divided by the square of height in meters. A high BMI can indicate high body fatness and may lead to health problems.

  end of study at 3 months

Secondary Outcomes (57)

• Number of Participants Who Were Responsive to Interactive 2-way Messages

  12 Weeks

• Number of Participants Who Were Engaged Every Week

  12 weeks

• Level of Engagement

  Over 12 weeks of time

• Hemoglobin A1c

  baseline

• Hemoglobin A1c

  end of study at 3 months

Study Arms (2)

Text messaging program

EXPERIMENTAL

Enrolled participants received the pilot text messaging program.

Behavioral: Text messaging

Virtual peer education

EXPERIMENTAL

Enrolled participants received a virtual peer education diabetes prevention program.

Behavioral: Virtual workshop

Interventions

Text messaging BEHAVIORAL

text messaging content to support diabetes prevention.

Text messaging program

Virtual workshop BEHAVIORAL

virtual workshop content to support diabetes prevention.

Virtual peer education

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Nita Vangeepuram
• Organization: Icahn School of Medicine at Mount Sinai

nita.vangeepuram@mssm.edu

917-478-2106

Study Officials

• Nita Vangeepuram

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: August 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: December 29, 2023
• Results First Posted: December 29, 2023

Record last verified: 2023-12-16

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)