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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05560386
• Other study ID #: GCO 17-2272
• Secondary ID: 5R03DK118302-02
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: December 16, 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Behavioral:
• Text messaging
text messaging content to support diabetes prevention.
• Virtual workshop
virtual workshop content to support diabetes prevention.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Waist Circumference	Waist circumference for boys/girls 10th-90th percentile ranges from 63.0-116.5 cm. Higher percentile indicates higher metabolic risk.	baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Total Cholesterol	(<200 is low risk, 200-239 borderline, >240 high risk).	baseline
Secondary	Total Cholesterol	(<200 is low risk, 200-239 borderline, >240 high risk).	end of study at 3 months
Secondary	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
Secondary	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
Secondary	High Density Lipoprotein (HDL)	(>60 is good, 40-59 is normal, <40 is associated with increased risk of heart disease).	baseline
Secondary	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
Secondary	Triglycerides	(<150 is normal, 150-199 is borderline, 200-499 is high).	baseline
Secondary	Triglycerides	(<150 is normal, 150-199 is borderline, 200-499 is high).	end of study at 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Daily MVPA Hours	Daily MVPA (moderate to vigorous physical activity) hours of moderate to vigorous physical activity (daily, average over the last week)	baseline
Secondary	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
Secondary	Strenuous Exercise Hours	Hours of strenuous physical activity (daily, average over the last week).	baseline
Secondary	Strenuous Exercise Hours	Hours of strenuous physical activity (daily, average over the last week).	end of study at 3 months
Secondary	Moderate Exercise Hours	Hours of moderate physical activity (daily, average over the last week).	baseline
Secondary	Moderate Exercise Hours	Hours of moderate physical activity (daily, average over the last week).	end of study at 3 months
Secondary	Mild Exercise Hours	Hours of mild physical activity (daily, average over the last week).	baseline
Secondary	Mild Exercise Hours	Hours of mild physical activity (daily, average over the last week).	end of study at 3 months
Secondary	Time Spent Doing Physically Active Chores	Hours of physically active chores (daily, average over the last week).	baseline
Secondary	Time Spent Doing Physically Active Chores	Hours of physically active chores (daily, average over the last week).	end of study at 3 months
Secondary	Time Spent Walking	Hours of walking (daily, average over the last week).	baseline
Secondary	Time Spent Walking	Hours of walking (daily, average over the last week).	end of study at 3 months
Secondary	Time Spent Doing Unscheduled/Unstructured Physical Activity	Hours of Unscheduled/unstructured PA (daily, average over the last week).	baseline
Secondary	Time Spent Doing Unscheduled/Unstructured Physical Activity	Hours of Unscheduled/unstructured PA (daily, average over the last week).	end of study at 3 months
Secondary	Screentime -Weekday	Screen time on the weekdays in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.	baseline
Secondary	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
Secondary	Screentime-weekend	Screen time on the weekend in hours (daily, average) - Combined TV, computer, video games, smartphone/Ipad/etc.	baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Self-Image Score	Total range score from 6-24; higher score indicates better self-image	baseline
Secondary	Self-Image Score	Total range score from 6-24; higher score indicates better self-image	end of study at 3 months
Secondary	Depression Score	Total range score from 6-18; higher score indicates more depression symptoms	baseline
Secondary	Depression Score	Total range score from 6-18; higher score indicates more depression symptoms	end of study at 3 months
Secondary	Body Satisfaction Score	Total range score from 10-60; higher score indicates higher body satisfaction	baseline
Secondary	Body Satisfaction Score	Total range score from 10-60; higher score indicates higher body satisfaction	end of study at 3 months
Secondary	Emotional Eating Score	Total range score from 5-20; higher score indicates more emotional eating	baseline
Secondary	Emotional Eating Score	Total range score from 5-20; higher score indicates more emotional eating	end of study at 3 months