Skip to main content
OpenTrials
Completed

NCT Number: NCT05560386

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text messaging

Behavioral

text messaging content to support diabetes prevention.

Virtual workshop

Behavioral

virtual workshop content to support diabetes prevention.

Primary outcomes

  1. Body Mass Index (BMI)

    Time frame: baseline

    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.

  2. Body Mass Index (BMI)

    Time frame: 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 outcomes

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

    Time frame: 12 Weeks

    Text Messaging Program - Number of participants who were responsive to interactive 2-way messages

  2. Number of Participants Who Were Engaged Every Week

    Time frame: 12 weeks

    Text Messaging Program - Number of participants who initially consented to the study who were engaged every week

  3. Level of Engagement

    Time frame: 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.

  4. Hemoglobin A1c

    Time frame: baseline

    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)

  5. Hemoglobin A1c

    Time frame: 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)

  6. Body Fat %

    Time frame: baseline

    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.

  7. Body Fat %

    Time frame: 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.

  8. Waist Circumference

    Time frame: baseline

    Waist circumference for boys/girls 10th-90th percentile ranges from 63.0-116.5 cm. Higher percentile indicates higher metabolic risk.

  9. Waist Circumference

    Time frame: 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.

  10. Blood Pressure - Systolic and Diastolic Blood Pressures

    Time frame: baseline

    Blood pressure is the pressure of circulating blood against the walls of blood vessels. Higher blood pressure may indicate higher metabolic risk.

  11. Blood Pressure - Systolic and Diastolic Blood Pressures

    Time frame: 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.

  12. Total Cholesterol

    Time frame: baseline

    (<200 is low risk, 200-239 borderline, >240 high risk).

  13. Total Cholesterol

    Time frame: end of study at 3 months

    (<200 is low risk, 200-239 borderline, >240 high risk).

  14. Low Density Lipoprotein (LDL)

    Time frame: baseline

    (<100 is best, 100-129 is acceptable for those with no health issues, 130-159 is borderline, 160-189 is high).

  15. Low Density Lipoprotein (LDL)

    Time frame: 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).

  16. High Density Lipoprotein (HDL)

    Time frame: baseline

    (>60 is good, 40-59 is normal, <40 is associated with increased risk of heart disease).

  17. High Density Lipoprotein (HDL)

    Time frame: end of study at 3 months

    (>60 is good, 40-59 is normal, <40 is associated with increased risk of heart disease).

  18. Triglycerides

    Time frame: baseline

    (<150 is normal, 150-199 is borderline, 200-499 is high).

  19. Triglycerides

    Time frame: end of study at 3 months

    (<150 is normal, 150-199 is borderline, 200-499 is high).

  20. Portion Control

    Time frame: baseline

    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.

  21. Portion Control

    Time frame: 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.

  22. Self-Efficacy Healthy Eating Subscale 1

    Time frame: baseline

    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.

  23. Self-Efficacy Healthy Eating Subscale 1

    Time frame: 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.

  24. Self-Efficacy Health Eating Subscale 2

    Time frame: baseline

    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.

  25. Self-Efficacy Health Eating Subscale 2

    Time frame: 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.

  26. Perceived Barriers to Health Eating

    Time frame: baseline

    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.

  27. Perceived Barriers to Health Eating

    Time frame: 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.

  28. Daily MVPA Hours

    Time frame: baseline

    Daily MVPA (moderate to vigorous physical activity) hours of moderate to vigorous physical activity (daily, average over the last week)

  29. Daily MVPA Hours

    Time frame: 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)

  30. Strenuous Exercise Hours

    Time frame: baseline

    Hours of strenuous physical activity (daily, average over the last week).

  31. Strenuous Exercise Hours

    Time frame: end of study at 3 months

    Hours of strenuous physical activity (daily, average over the last week).

  32. Moderate Exercise Hours

    Time frame: baseline

    Hours of moderate physical activity (daily, average over the last week).

  33. Moderate Exercise Hours

    Time frame: end of study at 3 months

    Hours of moderate physical activity (daily, average over the last week).

  34. Mild Exercise Hours

    Time frame: baseline

    Hours of mild physical activity (daily, average over the last week).

  35. Mild Exercise Hours

    Time frame: end of study at 3 months

    Hours of mild physical activity (daily, average over the last week).

  36. Time Spent Doing Physically Active Chores

    Time frame: baseline

    Hours of physically active chores (daily, average over the last week).

  37. Time Spent Doing Physically Active Chores

    Time frame: end of study at 3 months

    Hours of physically active chores (daily, average over the last week).

  38. Time Spent Walking

    Time frame: baseline

    Hours of walking (daily, average over the last week).

  39. Time Spent Walking

    Time frame: end of study at 3 months

    Hours of walking (daily, average over the last week).

  40. Time Spent Doing Unscheduled/Unstructured Physical Activity

    Time frame: baseline

    Hours of Unscheduled/unstructured PA (daily, average over the last week).

  41. Time Spent Doing Unscheduled/Unstructured Physical Activity

    Time frame: end of study at 3 months

    Hours of Unscheduled/unstructured PA (daily, average over the last week).

  42. Screentime -Weekday

    Time frame: baseline

    Screen time on the weekdays in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.

  43. Screentime -Weekday

    Time frame: end of study at 3 months

    Screen time on the weekdays in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.

  44. Screentime-weekend

    Time frame: baseline

    Screen time on the weekend in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.

  45. Screentime-weekend

    Time frame: end of study at 3 months

    Screen time on the weekend in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.

  46. Physical Activity Self Efficacy Score

    Time frame: baseline

    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.

  47. Physical Activity Self Efficacy Score

    Time frame: 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.

  48. Perceived Barriers to Physical Activity Score

    Time frame: baseline

    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.

  49. Perceived Barriers to Physical Activity Score

    Time frame: 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.

  50. Self-Image Score

    Time frame: baseline

    Total range score from 6-24; higher score indicates better self-image

  51. Self-Image Score

    Time frame: end of study at 3 months

    Total range score from 6-24; higher score indicates better self-image

  52. Depression Score

    Time frame: baseline

    Total range score from 6-18; higher score indicates more depression symptoms

  53. Depression Score

    Time frame: end of study at 3 months

    Total range score from 6-18; higher score indicates more depression symptoms

  54. Body Satisfaction Score

    Time frame: baseline

    Total range score from 10-60; higher score indicates higher body satisfaction

  55. Body Satisfaction Score

    Time frame: end of study at 3 months

    Total range score from 10-60; higher score indicates higher body satisfaction

  56. Emotional Eating Score

    Time frame: baseline

    Total range score from 5-20; higher score indicates more emotional eating

  57. Emotional Eating Score

    Time frame: end of study at 3 months

    Total range score from 5-20; higher score indicates more emotional eating

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2022
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.