N/A
N=54
TEEN HEED: An Adolescent Diabetes Prevention Intervention Incorporating Novel Mobile Health Technologies
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05560386 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Body Mass Index (BMI) — 32.95 kg/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Text messaging (Behavioral); Virtual workshop (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Mass Index (BMI) |
32.8 | — |
| PRIMARY Body Mass Index (BMI) |
32.8 | — |
| SECONDARY Number of Participants Who Were Responsive to Interactive 2-way Messages |
11 | — |
| SECONDARY Number of Participants Who Were Engaged Every Week |
9 | — |
| SECONDARY Level of Engagement |
0; 15; 31; 8; 46 | — |
| SECONDARY Hemoglobin A1c |
5.75 | — |
| SECONDARY Hemoglobin A1c |
5.75 | — |
| SECONDARY Body Fat % |
36.16 | — |
| SECONDARY Body Fat % |
36.16 | — |
| SECONDARY Waist Circumference |
104.45 | — |
| SECONDARY Waist Circumference |
104.45 | — |
| SECONDARY Blood Pressure - Systolic and Diastolic Blood Pressures |
115.33; 62.67 | — |
| SECONDARY Blood Pressure - Systolic and Diastolic Blood Pressures |
115.33; 62.67 | — |
| SECONDARY Total Cholesterol |
171.25 | — |
| SECONDARY Total Cholesterol |
171.25 | — |
| SECONDARY Low Density Lipoprotein (LDL) |
109.46 | — |
| SECONDARY Low Density Lipoprotein (LDL) |
109.46 | — |
| SECONDARY High Density Lipoprotein (HDL) |
42.14 | — |
| SECONDARY High Density Lipoprotein (HDL) |
42.14 | — |
| SECONDARY Triglycerides |
73.5 | — |
| SECONDARY Triglycerides |
73.5 | — |
| SECONDARY Portion Control |
25.1 | — |
| SECONDARY Portion Control |
25.1 | — |
| SECONDARY Self-Efficacy Healthy Eating Subscale 1 |
26.9 | — |
| SECONDARY Self-Efficacy Healthy Eating Subscale 1 |
26.9 | — |
| SECONDARY Self-Efficacy Health Eating Subscale 2 |
18.9 | — |
| SECONDARY Self-Efficacy Health Eating Subscale 2 |
18.9 | — |
| SECONDARY Perceived Barriers to Health Eating |
7.7 | — |
| SECONDARY Perceived Barriers to Health Eating |
7.7 | — |
| SECONDARY Daily MVPA Hours |
1.4 | — |
| SECONDARY Daily MVPA Hours |
1.4 | — |
| SECONDARY Strenuous Exercise Hours |
0.7 | — |
| SECONDARY Strenuous Exercise Hours |
0.7 | — |
| SECONDARY Moderate Exercise Hours |
0.7 | — |
| SECONDARY Moderate Exercise Hours |
0.7 | — |
| SECONDARY Mild Exercise Hours |
0.7 | — |
| SECONDARY Mild Exercise Hours |
0.7 | — |
| SECONDARY Time Spent Doing Physically Active Chores |
0.8 | — |
| SECONDARY Time Spent Doing Physically Active Chores |
0.8 | — |
| SECONDARY Time Spent Walking |
0.7 | — |
| SECONDARY Time Spent Walking |
0.7 | — |
| SECONDARY Time Spent Doing Unscheduled/Unstructured Physical Activity |
0.7 | — |
| SECONDARY Time Spent Doing Unscheduled/Unstructured Physical Activity |
0.7 | — |
| SECONDARY Screentime -Weekday |
5.9 | — |
| SECONDARY Screentime -Weekday |
5.9 | — |
| SECONDARY Screentime-weekend |
15.6 | — |
| SECONDARY Screentime-weekend |
15.6 | — |
| SECONDARY Physical Activity Self Efficacy Score |
20.2 | — |
| SECONDARY Physical Activity Self Efficacy Score |
20.2 | — |
| SECONDARY Perceived Barriers to Physical Activity Score |
14.2 | — |
| SECONDARY Perceived Barriers to Physical Activity Score |
14.2 | — |
| SECONDARY Self-Image Score |
16.1 | — |
| SECONDARY Self-Image Score |
16.1 | — |
| SECONDARY Depression Score |
10.9 | — |
| SECONDARY Depression Score |
10.9 | — |
| SECONDARY Body Satisfaction Score |
27.1 | — |
| SECONDARY Body Satisfaction Score |
27.1 | — |
| SECONDARY Emotional Eating Score |
6.6 | — |
| SECONDARY Emotional Eating Score |
6.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05560386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.