Type 2 DiabetesNCT05560386
TEEN HEED: An Adolescent Diabetes Prevention Intervention Incorporating Novel Mobile Health Technologies
A study testing Text messaging and Virtual workshop in people with Type 2 Diabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Text messaging and Virtual workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 31 Mar 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
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- 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
Who cannot join
- Medical or developmental conditions which would make it difficult to participate in a virtual group educational program
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Text messaging, Virtual workshop
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messagingBehavioural
text messaging content to support diabetes prevention.
Virtual workshopBehavioural
virtual workshop content to support diabetes prevention.
| Study group | Role | What they receive |
|---|---|---|
| Text messaging program | Experimental | Enrolled participants received the pilot text messaging program. Receives: Behavioral: Text messaging |
| Virtual peer education | Experimental | Enrolled participants received a virtual peer education diabetes prevention program. Receives: Behavioral: Virtual workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: end of study at 3 months
Secondary outcomes (57)
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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Waist Circumference
Waist circumference for boys/girls 10th-90th percentile ranges from 63.0-116.5 cm. Higher percentile indicates higher metabolic risk.
Measured: 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.
Measured: 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.
Measured: end of study at 3 months
Total Cholesterol
(<200 is low risk, 200-239 borderline, >240 high risk).
Measured: baseline
Total Cholesterol
(<200 is low risk, 200-239 borderline, >240 high risk).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: baseline
High Density Lipoprotein (HDL)
(>60 is good, 40-59 is normal, <40 is associated with increased risk of heart disease).
Measured: end of study at 3 months
Triglycerides
(<150 is normal, 150-199 is borderline, 200-499 is high).
Measured: baseline
Triglycerides
(<150 is normal, 150-199 is borderline, 200-499 is high).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: baseline
Daily MVPA Hours
Daily MVPA (moderate to vigorous physical activity) hours of moderate to vigorous physical activity (daily, average over the last week)
Measured: end of study at 3 months
Strenuous Exercise Hours
Hours of strenuous physical activity (daily, average over the last week).
Measured: baseline
Strenuous Exercise Hours
Hours of strenuous physical activity (daily, average over the last week).
Measured: end of study at 3 months
Moderate Exercise Hours
Hours of moderate physical activity (daily, average over the last week).
Measured: baseline
Moderate Exercise Hours
Hours of moderate physical activity (daily, average over the last week).
Measured: end of study at 3 months
Mild Exercise Hours
Hours of mild physical activity (daily, average over the last week).
Measured: baseline
Mild Exercise Hours
Hours of mild physical activity (daily, average over the last week).
Measured: end of study at 3 months
Time Spent Doing Physically Active Chores
Hours of physically active chores (daily, average over the last week).
Measured: baseline
Time Spent Doing Physically Active Chores
Hours of physically active chores (daily, average over the last week).
Measured: end of study at 3 months
Time Spent Walking
Hours of walking (daily, average over the last week).
Measured: baseline
Time Spent Walking
Hours of walking (daily, average over the last week).
Measured: end of study at 3 months
Time Spent Doing Unscheduled/Unstructured Physical Activity
Hours of Unscheduled/unstructured PA (daily, average over the last week).
Measured: baseline
Time Spent Doing Unscheduled/Unstructured Physical Activity
Hours of Unscheduled/unstructured PA (daily, average over the last week).
Measured: 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.
Measured: baseline
Screentime -Weekday
Screen time on the weekdays in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.
Measured: 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.
Measured: baseline
Screentime-weekend
Screen time on the weekend in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: end of study at 3 months
Self-Image Score
Total range score from 6-24; higher score indicates better self-image
Measured: baseline
Self-Image Score
Total range score from 6-24; higher score indicates better self-image
Measured: end of study at 3 months
Depression Score
Total range score from 6-18; higher score indicates more depression symptoms
Measured: baseline
Depression Score
Total range score from 6-18; higher score indicates more depression symptoms
Measured: end of study at 3 months
Body Satisfaction Score
Total range score from 10-60; higher score indicates higher body satisfaction
Measured: baseline
Body Satisfaction Score
Total range score from 10-60; higher score indicates higher body satisfaction
Measured: end of study at 3 months
Emotional Eating Score
Total range score from 5-20; higher score indicates more emotional eating
Measured: baseline
Emotional Eating Score
Total range score from 5-20; higher score indicates more emotional eating
Measured: end of study at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Aug 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nita Vangeepuram, Icahn School of Medicine at Mount Sinai
- Investigators
- Nita Vangeepuram, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560386
- Sponsor's protocol ID
- GCO 17-2272
- Other IDs
- 5R03DK118302-02
- Status last verified
- 16 Dec 2023
- First submitted
- 26 Sep 2022
- Last updated
- 29 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No