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

Study Overview
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Brief Summary
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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: Synthesize real-time data and analytics and conduct user interface (UI) testing to refine and enhance features of the prototype text messaging platform. 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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Text messaging
* Behavioral: Virtual workshop


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text messaging program<br>Enrolled participants received the pilot text messaging program. | Behavioral: Text messaging<br>* text messaging content to support diabetes prevention.<br>|
| Experimental: Virtual peer education<br>Enrolled participants received a virtual peer education diabetes prevention program. | Behavioral: Virtual workshop<br>* virtual workshop content to support diabetes prevention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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