Clinical trial NCT05560386: TEEN HEED: An Adolescent Diabetes Prevention Intervention Incorporating Novel Mobile Health Technologies
Official title: TEEN HEED: An Adolescent Diabetes Prevention Intervention Incorporating Novel Mobile Health Technologies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-09-29
Enrollment: 54
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: baseline
measure: Body Mass Index (BMI)
timeFrame: end of study at 3 months
Secondary outcomes:
measure: Number of Participants Who Were Responsive to Interactive 2-way Messages
timeFrame: 12 Weeks
measure: Number of Participants Who Were Engaged Every Week
timeFrame: 12 weeks
measure: Level of Engagement
timeFrame: Over 12 weeks of time
measure: Hemoglobin A1c
timeFrame: baseline
measure: Hemoglobin A1c
timeFrame: end of study at 3 months
measure: Body Fat %
timeFrame: baseline
measure: Body Fat %
timeFrame: end of study at 3 months
measure: Waist Circumference
timeFrame: baseline
measure: Waist Circumference
timeFrame: end of study at 3 months
measure: Blood Pressure - Systolic and Diastolic Blood Pressures
timeFrame: baseline
measure: Blood Pressure - Systolic and Diastolic Blood Pressures
timeFrame: end of study at 3 months
measure: Total Cholesterol
timeFrame: baseline
measure: Total Cholesterol
timeFrame: end of study at 3 months
measure: Low Density Lipoprotein (LDL)
timeFrame: baseline
measure: Low Density Lipoprotein (LDL)
timeFrame: end of study at 3 months
measure: High Density Lipoprotein (HDL)
timeFrame: baseline
measure: High Density Lipoprotein (HDL)
timeFrame: end of study at 3 months
measure: Triglycerides
timeFrame: baseline
measure: Triglycerides
timeFrame: end of study at 3 months
measure: Portion Control
timeFrame: baseline
measure: Portion Control
timeFrame: end of study at 3 months
measure: Self-Efficacy Healthy Eating Subscale 1
timeFrame: baseline
measure: Self-Efficacy Healthy Eating Subscale 1
timeFrame: end of study at 3 months
measure: Self-Efficacy Health Eating Subscale 2
timeFrame: baseline
measure: Self-Efficacy Health Eating Subscale 2
timeFrame: end of study at 3 months
measure: Perceived Barriers to Health Eating
timeFrame: baseline
measure: Perceived Barriers to Health Eating
timeFrame: end of study at 3 months
measure: Daily MVPA Hours
timeFrame: baseline
measure: Daily MVPA Hours
timeFrame: end of study at 3 months
measure: Strenuous Exercise Hours
timeFrame: baseline
measure: Strenuous Exercise Hours
timeFrame: end of study at 3 months
measure: Moderate Exercise Hours
timeFrame: baseline
measure: Moderate Exercise Hours
timeFrame: end of study at 3 months
measure: Mild Exercise Hours
timeFrame: baseline
measure: Mild Exercise Hours
timeFrame: end of study at 3 months
measure: Time Spent Doing Physically Active Chores
timeFrame: baseline
measure: Time Spent Doing Physically Active Chores
timeFrame: end of study at 3 months
measure: Time Spent Walking
timeFrame: baseline
measure: Time Spent Walking
timeFrame: end of study at 3 months
measure: Time Spent Doing Unscheduled/Unstructured Physical Activity
timeFrame: baseline
measure: Time Spent Doing Unscheduled/Unstructured Physical Activity
timeFrame: end of study at 3 months
measure: Screentime -Weekday
timeFrame: baseline
measure: Screentime -Weekday
timeFrame: end of study at 3 months
measure: Screentime-weekend
timeFrame: baseline
measure: Screentime-weekend
timeFrame: end of study at 3 months
measure: Physical Activity Self Efficacy Score
timeFrame: baseline
measure: Physical Activity Self Efficacy Score
timeFrame: end of study at 3 months
measure: Perceived Barriers to Physical Activity Score
timeFrame: baseline
measure: Perceived Barriers to Physical Activity Score
timeFrame: end of study at 3 months
measure: Self-Image Score
timeFrame: baseline
measure: Self-Image Score
timeFrame: end of study at 3 months
measure: Depression Score
timeFrame: baseline
measure: Depression Score
timeFrame: end of study at 3 months
measure: Body Satisfaction Score
timeFrame: baseline
measure: Body Satisfaction Score
timeFrame: end of study at 3 months
measure: Emotional Eating Score
timeFrame: baseline
measure: Emotional Eating Score
timeFrame: end of study at 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nita Vangeepuram
role: PRINCIPAL_INVESTIGATOR
References: