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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
54
text messaging content to support diabetes prevention.
virtual workshop content to support diabetes prevention.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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.
Time frame: 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.
Time frame: end of study at 3 months
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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline
Waist Circumference
Waist circumference for boys/girls 10th-90th percentile ranges from 63.0-116.5 cm. Higher percentile indicates higher metabolic risk.
Time frame: 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.
Time frame: 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.
Time frame: end of study at 3 months
Total Cholesterol
(\<200 is low risk, 200-239 borderline, \>240 high risk).
Time frame: baseline
Total Cholesterol
(\<200 is low risk, 200-239 borderline, \>240 high risk).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: baseline
High Density Lipoprotein (HDL)
(\>60 is good, 40-59 is normal, \<40 is associated with increased risk of heart disease).
Time frame: end of study at 3 months
Triglycerides
(\<150 is normal, 150-199 is borderline, 200-499 is high).
Time frame: baseline
Triglycerides
(\<150 is normal, 150-199 is borderline, 200-499 is high).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: baseline
Daily MVPA Hours
Daily MVPA (moderate to vigorous physical activity) hours of moderate to vigorous physical activity (daily, average over the last week)
Time frame: end of study at 3 months
Strenuous Exercise Hours
Hours of strenuous physical activity (daily, average over the last week).
Time frame: baseline
Strenuous Exercise Hours
Hours of strenuous physical activity (daily, average over the last week).
Time frame: end of study at 3 months
Moderate Exercise Hours
Hours of moderate physical activity (daily, average over the last week).
Time frame: baseline
Moderate Exercise Hours
Hours of moderate physical activity (daily, average over the last week).
Time frame: end of study at 3 months
Mild Exercise Hours
Hours of mild physical activity (daily, average over the last week).
Time frame: baseline
Mild Exercise Hours
Hours of mild physical activity (daily, average over the last week).
Time frame: end of study at 3 months
Time Spent Doing Physically Active Chores
Hours of physically active chores (daily, average over the last week).
Time frame: baseline
Time Spent Doing Physically Active Chores
Hours of physically active chores (daily, average over the last week).
Time frame: end of study at 3 months
Time Spent Walking
Hours of walking (daily, average over the last week).
Time frame: baseline
Time Spent Walking
Hours of walking (daily, average over the last week).
Time frame: end of study at 3 months
Time Spent Doing Unscheduled/Unstructured Physical Activity
Hours of Unscheduled/unstructured PA (daily, average over the last week).
Time frame: baseline
Time Spent Doing Unscheduled/Unstructured Physical Activity
Hours of Unscheduled/unstructured PA (daily, average over the last week).
Time frame: 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.
Time frame: baseline
Screentime -Weekday
Screen time on the weekdays in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.
Time frame: 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.
Time frame: baseline
Screentime-weekend
Screen time on the weekend in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: end of study at 3 months
Self-Image Score
Total range score from 6-24; higher score indicates better self-image
Time frame: baseline
Self-Image Score
Total range score from 6-24; higher score indicates better self-image
Time frame: end of study at 3 months
Depression Score
Total range score from 6-18; higher score indicates more depression symptoms
Time frame: baseline
Depression Score
Total range score from 6-18; higher score indicates more depression symptoms
Time frame: end of study at 3 months
Body Satisfaction Score
Total range score from 10-60; higher score indicates higher body satisfaction
Time frame: baseline
Body Satisfaction Score
Total range score from 10-60; higher score indicates higher body satisfaction
Time frame: end of study at 3 months
Emotional Eating Score
Total range score from 5-20; higher score indicates more emotional eating
Time frame: baseline
Emotional Eating Score
Total range score from 5-20; higher score indicates more emotional eating
Time frame: end of study at 3 months
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