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

Not Applicable

Completed

Conditions: Type 2 Diabetes

Interventions: Behavioral: Text messaging
Behavioral: Virtual workshop

Registration Number: NCT05560386

Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 54

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Text messaging program	Text messaging	Enrolled participants received the pilot text messaging program.
Virtual peer education	Virtual workshop	Enrolled participants received a virtual peer education diabetes prevention program.

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	end of study at 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Were Responsive to Interactive 2-way Messages	12 Weeks	Text Messaging Program - Number of participants who were responsive to interactive 2-way messages
Number of Participants Who Were Engaged Every Week	12 weeks	Text Messaging Program - Number of participants who initially consented to the study who were engaged every week
Low Density Lipoprotein (LDL)	end of study at 3 months	(\<100 is best, 100-129 is acceptable for those with no health issues, 130-159 is borderline, 160-189 is high).
Triglycerides	end of study at 3 months	(\<150 is normal, 150-199 is borderline, 200-499 is high).
Portion Control	end of study at 3 months	This is a validated scale to measure how well someone controls the amount of food they eat. The total scale value ranges from 8-32; higher score indicates better portion control.
Mild Exercise Hours	end of study at 3 months	Hours of mild physical activity (daily, average over the last week).
Physical Activity Self Efficacy Score	end of study at 3 months	This is a validated scale to measure how confident participants are that they can eat healthy. The total scale value ranges from 6-24; higher score indicates higher self-efficacy.
Self-Efficacy Healthy Eating Subscale 1	end of study at 3 months	This is a validated scale to measure how confident someone is that they can eat healthy. The total scale value ranges from 8-40; higher score indicates higher self-efficacy.
Level of Engagement	Over 12 weeks of time	Text Messaging Program - Level of engagement as measured by responsiveness to 2-way interactive messages. Percent responding over the 12 weeks.
Waist Circumference	end of study at 3 months	Waist circumference for boys/girls 10th-90th percentile ranges from 63.0-116.5 cm. Higher percentile indicates higher metabolic risk.
High Density Lipoprotein (HDL)	end of study at 3 months	(\>60 is good, 40-59 is normal, \<40 is associated with increased risk of heart disease).
Screentime -Weekday	end of study at 3 months	Screen time on the weekdays in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.
Screentime-weekend	end of study at 3 months	Screen time on the weekend in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.
Self-Image Score	end of study at 3 months	Total range score from 6-24; higher score indicates better self-image
Depression Score	end of study at 3 months	Total range score from 6-18; higher score indicates more depression symptoms
Hemoglobin A1c	end of study at 3 months	A1C is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well a person is controlling blood sugar to help prevent complications from diabetes. Hemoglobin A1c (per American Diabetes Association): normal is 4-5.6% (5.7-6.4% is prediabetes and \>6.5% is diabetes level)
Body Fat %	end of study at 3 months	For girls normal range is 16-31% for ages 13-18 years; for boys normal range is 10-22% for ages 13-18 years. Higher % indicates higher metabolic risk.
Blood Pressure - Systolic and Diastolic Blood Pressures	end of study at 3 months	Blood pressure is the pressure of circulating blood against the walls of blood vessels. Higher blood pressure may indicate higher metabolic risk.
Total Cholesterol	end of study at 3 months	(\<200 is low risk, 200-239 borderline, \>240 high risk).
Self-Efficacy Health Eating Subscale 2	end of study at 3 months	This is a validated scale to measure how confident someone is that they can eat healthy. The total scale value ranges from 5-25; higher score indicates higher self-efficacy.
Perceived Barriers to Health Eating	end of study at 3 months	This is a scale to measure participants perceptions about the barriers they face for eating healthy. The total scale value ranges from 4-16; higher score indicates more perceived barriers.
Daily MVPA Hours	end of study at 3 months	Daily MVPA (moderate to vigorous physical activity) hours of moderate to vigorous physical activity (daily, average over the last week)
Strenuous Exercise Hours	end of study at 3 months	Hours of strenuous physical activity (daily, average over the last week).
Moderate Exercise Hours	end of study at 3 months	Hours of moderate physical activity (daily, average over the last week).
Time Spent Doing Physically Active Chores	end of study at 3 months	Hours of physically active chores (daily, average over the last week).
Time Spent Walking	end of study at 3 months	Hours of walking (daily, average over the last week).
Time Spent Doing Unscheduled/Unstructured Physical Activity	end of study at 3 months	Hours of Unscheduled/unstructured PA (daily, average over the last week).
Body Satisfaction Score	end of study at 3 months	Total range score from 10-60; higher score indicates higher body satisfaction
Emotional Eating Score	end of study at 3 months	Total range score from 5-20; higher score indicates more emotional eating
Perceived Barriers to Physical Activity Score	end of study at 3 months	This is a scale to measure participants perceptions about the barriers they face for eating healthy. The total scale value ranges from 8-32; higher score indicates more perceived barriers.