- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Text messaging program
Enrolled participants received the pilot text messaging program.
|
text messaging content to support diabetes prevention.
|
Experimental: Virtual peer education
Enrolled participants received a virtual peer education diabetes prevention program.
|
virtual workshop content to support diabetes prevention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
baseline
|
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. |
end of study at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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) |
end of study at 3 months
|
Triglycerides
Time Frame: end of study at 3 months
|
(<150 is normal, 150-199 is borderline, 200-499 is high).
|
end of study at 3 months
|
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.
|
end of study at 3 months
|
Self-Image Score
Time Frame: end of study at 3 months
|
Total range score from 6-24; higher score indicates better self-image
|
end of study at 3 months
|
Depression Score
Time Frame: end of study at 3 months
|
Total range score from 6-18; higher score indicates more depression symptoms
|
end of study at 3 months
|
Body Satisfaction Score
Time Frame: end of study at 3 months
|
Total range score from 10-60; higher score indicates higher body satisfaction
|
end of study at 3 months
|
Emotional Eating Score
Time Frame: end of study at 3 months
|
Total range score from 5-20; higher score indicates more emotional eating
|
end of study at 3 months
|
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
|
12 Weeks
|
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
|
12 weeks
|
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. |
Over 12 weeks of time
|
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) |
baseline
|
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.
|
baseline
|
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.
|
end of study at 3 months
|
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.
|
baseline
|
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.
|
end of study at 3 months
|
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.
|
baseline
|
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.
|
end of study at 3 months
|
Total Cholesterol
Time Frame: baseline
|
(<200 is low risk, 200-239 borderline, >240 high risk).
|
baseline
|
Total Cholesterol
Time Frame: end of study at 3 months
|
(<200 is low risk, 200-239 borderline, >240 high risk).
|
end of study at 3 months
|
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).
|
baseline
|
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).
|
end of study at 3 months
|
High Density Lipoprotein (HDL)
Time Frame: baseline
|
(>60 is good, 40-59 is normal, <40 is associated with increased risk of heart disease).
|
baseline
|
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).
|
end of study at 3 months
|
Triglycerides
Time Frame: baseline
|
(<150 is normal, 150-199 is borderline, 200-499 is high).
|
baseline
|
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.
|
baseline
|
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.
|
end of study at 3 months
|
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.
|
baseline
|
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.
|
end of study at 3 months
|
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.
|
baseline
|
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.
|
end of study at 3 months
|
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.
|
baseline
|
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.
|
end of study at 3 months
|
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)
|
baseline
|
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)
|
end of study at 3 months
|
Strenuous Exercise Hours
Time Frame: baseline
|
Hours of strenuous physical activity (daily, average over the last week).
|
baseline
|
Strenuous Exercise Hours
Time Frame: end of study at 3 months
|
Hours of strenuous physical activity (daily, average over the last week).
|
end of study at 3 months
|
Moderate Exercise Hours
Time Frame: baseline
|
Hours of moderate physical activity (daily, average over the last week).
|
baseline
|
Moderate Exercise Hours
Time Frame: end of study at 3 months
|
Hours of moderate physical activity (daily, average over the last week).
|
end of study at 3 months
|
Mild Exercise Hours
Time Frame: baseline
|
Hours of mild physical activity (daily, average over the last week).
|
baseline
|
Mild Exercise Hours
Time Frame: end of study at 3 months
|
Hours of mild physical activity (daily, average over the last week).
|
end of study at 3 months
|
Time Spent Doing Physically Active Chores
Time Frame: baseline
|
Hours of physically active chores (daily, average over the last week).
|
baseline
|
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).
|
end of study at 3 months
|
Time Spent Walking
Time Frame: baseline
|
Hours of walking (daily, average over the last week).
|
baseline
|
Time Spent Walking
Time Frame: end of study at 3 months
|
Hours of walking (daily, average over the last week).
|
end of study at 3 months
|
Time Spent Doing Unscheduled/Unstructured Physical Activity
Time Frame: baseline
|
Hours of Unscheduled/unstructured PA (daily, average over the last week).
|
baseline
|
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).
|
end of study at 3 months
|
Screentime -Weekday
Time Frame: baseline
|
Screen time on the weekdays in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.
|
baseline
|
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.
|
end of study at 3 months
|
Screentime-weekend
Time Frame: baseline
|
Screen time on the weekend in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.
|
baseline
|
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.
|
baseline
|
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.
|
end of study at 3 months
|
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.
|
baseline
|
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.
|
end of study at 3 months
|
Self-Image Score
Time Frame: baseline
|
Total range score from 6-24; higher score indicates better self-image
|
baseline
|
Depression Score
Time Frame: baseline
|
Total range score from 6-18; higher score indicates more depression symptoms
|
baseline
|
Body Satisfaction Score
Time Frame: baseline
|
Total range score from 10-60; higher score indicates higher body satisfaction
|
baseline
|
Emotional Eating Score
Time Frame: baseline
|
Total range score from 5-20; higher score indicates more emotional eating
|
baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nita Vangeepuram, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 17-2272
- 5R03DK118302-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
University of Campania "Luigi Vanvitelli"CompletedType 2 Diabetes MellitusItaly
-
Population Health Research InstituteNovo Nordisk A/SCompletedType 2 Diabetes MellitusCanada
-
Northwell HealthPatient-Centered Outcomes Research InstituteCompletedType 2 Diabetes Mellitus | Type 2 DiabetesUnited States
-
Eli Lilly and CompanyCompletedType 2 Diabetes MellitusChina
-
University of MinnesotaUniversity of Southern California; Wake Forest UniversityCompleted
-
Joslin Diabetes CenterDHR Health Institute for Research and Development; Verizon FoundationCompletedType 2 Diabetes MellitusUnited States
Clinical Trials on Text messaging
-
University of Colorado, DenverNational Institute of Mental Health (NIMH)CompletedHIV InfectionsUnited States
-
VA Office of Research and DevelopmentVA Office of Connected CareCompleted
-
University of UtahEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruitingCOVID-19United States
-
University of StellenboschUniversity of British Columbia; McMaster UniversityCompletedText Messaging Plus Motivational Interviewing in Promotion of Breastfeeding Among HIV-infected WomenHIV Infections | Breast FeedingSouth Africa
-
Children's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)CompletedAdolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care (ACT Me)Persistent AsthmaUnited States
-
Hunter College of City University of New YorkRecruitingAlcohol ConsumptionUnited States
-
University of UtahBen B & Iris Margolis Private Foundation for Medical ResearchActive, not recruiting
-
University of RochesterCompleted
-
University of MichiganCompletedStroke | Hypertension
-
University of Nebraska LincolnThe Methodist Hospital Research InstituteCompletedDiabetes Mellitus, Type 2United States