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PI decision based on reduced staffing and funds.
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| Name | Class |
|---|---|
| University of Kansas | OTHER |
| Nemours Children's Clinic | OTHER |
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The goal of this longitudinal cohort study is to learn about a mHealth intervention in Type 1 Diabetes (T1D)
The main question[s] it aims to answer are:
Participants will:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NUDGE | Other | NUDGE is a brief mHealth text messaging intervention designed to promote activity in adolescents by allowing them to set, monitor, and receive feedback on daily PA goals through text message. |
| Measure | Description | Time Frame |
|---|---|---|
| %Daily Text Messages Exchanged Between Youth and the NUDGE Bot | percent of daily text messages exchanged between youth and the NUDGE bot | Through study completion, an average of 3.5 months |
| Moderate to Vigorous Physical Activity (MVPA) Levels | Participants' MVPA levels | Day 1, 30 and 90 |
| Measure | Description | Time Frame |
|---|---|---|
| %Days That Youth Wear the Actigraph | Percent of days that youth wear the actigraph | Day 1, 30 and 90 |
| %Daily Physical Activity (PA) Schedules That Participants Complete | percent of daily PA schedules that participants complete |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 12.00 to 21.99 with Type 1 Diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Mark Clements, MD | Children's Mercy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy | Kansas City | Missouri | 64111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19481250 | Background | Dabelea D. The accelerating epidemic of childhood diabetes. Lancet. 2009 Jun 13;373(9680):1999-2000. doi: 10.1016/S0140-6736(09)60874-6. Epub 2009 May 27. No abstract available. | |
| 17327312 | Background | Vehik K, Hamman RF, Lezotte D, Norris JM, Klingensmith G, Bloch C, Rewers M, Dabelea D. Increasing incidence of type 1 diabetes in 0- to 17-year-old Colorado youth. Diabetes Care. 2007 Mar;30(3):503-9. doi: 10.2337/dc06-1837. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Arm | Main group of patients 13.00 to 21.99 with T1D |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Arm | Main group of patients 13.00 to 21.99 with T1D |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | %Daily Text Messages Exchanged Between Youth and the NUDGE Bot | percent of daily text messages exchanged between youth and the NUDGE bot | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. | Posted | Through study completion, an average of 3.5 months |
|
|
11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Arm | Main group of patients 13.00 to 21.99 with T1D | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Priscilla Connell | Children's Mercy Research Institute | 8166014543 | Endocrine-RisingT1deAlliance@cmh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2024 | Jul 31, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 16, 2024 | Jul 31, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Day 1, 30 and 90 |
| Change in Participant HbA1c | Change in participant HbA1c | Through study completion, an average of 3.5 months |
| 28723318 | Background | Mayer-Davis EJ, Dabelea D, Lawrence JM. Incidence Trends of Type 1 and Type 2 Diabetes among Youths, 2002-2012. N Engl J Med. 2017 Jul 20;377(3):301. doi: 10.1056/NEJMc1706291. No abstract available. |
| 27044668 | Background | Miller GF, Coffield E, Leroy Z, Wallin R. Prevalence and Costs of Five Chronic Conditions in Children. J Sch Nurs. 2016 Oct;32(5):357-64. doi: 10.1177/1059840516641190. Epub 2016 Apr 4. |
| 31862756 | Background | American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S163-S182. doi: 10.2337/dc20-S013. |
| 28126459 | Background | Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24. |
| 24508755 | Background | Miculis CP, De Campos W, da Silva Boguszweski MC. Correlation between glycemic control and physical activity level in adolescents and children with type 1 diabetes. J Phys Act Health. 2015 Feb;12(2):232-7. doi: 10.1123/jpah.2013-0024. Epub 2014 Feb 5. |
| 24444038 | Background | Nguyen T, Obeid J, Walker RG, Krause MP, Hawke TJ, McAssey K, Vandermeulen J, Timmons BW. Fitness and physical activity in youth with type 1 diabetes mellitus in good or poor glycemic control. Pediatr Diabetes. 2015 Feb;16(1):48-57. doi: 10.1111/pedi.12117. Epub 2014 Jan 20. |
| 27475093 | Background | Tully C, Aronow L, Mackey E, Streisand R. Physical Activity in Youth With Type 1 Diabetes: a Review. Curr Diab Rep. 2016 Sep;16(9):85. doi: 10.1007/s11892-016-0779-6. |
| 28131985 | Background | Cushing CC, Mitchell TB, Bejarano CM, Walters RW, Crick CJ, Noser AE. Bidirectional Associations Between Psychological States and Physical Activity in Adolescents: A mHealth Pilot Study. J Pediatr Psychol. 2017 Jun 1;42(5):559-568. doi: 10.1093/jpepsy/jsw099. |
| Background | Lenhart, A. (2015). Teens, Social Media, & Technology Overview. Retrieved from http://pewinternet.org/2015/04/09/teens-social-media-technology-2015/ |
| 28319239 | Background | Fedele DA, Cushing CC, Fritz A, Amaro CM, Ortega A. Mobile Health Interventions for Improving Health Outcomes in Youth: A Meta-analysis. JAMA Pediatr. 2017 May 1;171(5):461-469. doi: 10.1001/jamapediatrics.2017.0042. |
| 25576494 | Background | Yang CH, Maher JP, Conroy DE. Implementation of behavior change techniques in mobile applications for physical activity. Am J Prev Med. 2015 Apr;48(4):452-5. doi: 10.1016/j.amepre.2014.10.010. Epub 2015 Jan 6. |
| 25502745 | Background | Brannon EE, Cushing CC. A systematic review: is there an app for that? Translational science of pediatric behavior change for physical activity and dietary interventions. J Pediatr Psychol. 2015 May;40(4):373-84. doi: 10.1093/jpepsy/jsu108. Epub 2014 Dec 13. |
| 19916637 | Background | Michie S, Abraham C, Whittington C, McAteer J, Gupta S. Effective techniques in healthy eating and physical activity interventions: a meta-regression. Health Psychol. 2009 Nov;28(6):690-701. doi: 10.1037/a0016136. |
| 26429638 | Background | Militello LK, Melnyk BM, Hekler E, Small L, Jacobson D. Correlates of Healthy Lifestyle Beliefs and Behaviors in Parents of Overweight or Obese Preschool Children Before and After a Cognitive Behavioral Therapy Intervention With Text Messaging. J Pediatr Health Care. 2016 May-Jun;30(3):252-60. doi: 10.1016/j.pedhc.2015.08.002. Epub 2015 Oct 1. |
| 33484137 | Background | Cushing CC, Bejarano CM, Ortega A, Sayre N, Fedele DA, Smyth JM. Adaptive mHealth Intervention for Adolescent Physical Activity Promotion. J Pediatr Psychol. 2021 Jun 3;46(5):536-546. doi: 10.1093/jpepsy/jsaa125. |
| 7134324 | Background | Carver CS, Scheier MF. Control theory: a useful conceptual framework for personality-social, clinical, and health psychology. Psychol Bull. 1982 Jul;92(1):111-35. No abstract available. |
| 20392790 | Background | Cushing CC, Steele RG. A meta-analytic review of eHealth interventions for pediatric health promoting and maintaining behaviors. J Pediatr Psychol. 2010 Oct;35(9):937-49. doi: 10.1093/jpepsy/jsq023. Epub 2010 Apr 14. |
| 23448694 | Background | Bergenstal RM, Ahmann AJ, Bailey T, Beck RW, Bissen J, Buckingham B, Deeb L, Dolin RH, Garg SK, Goland R, Hirsch IB, Klonoff DC, Kruger DF, Matfin G, Mazze RS, Olson BA, Parkin C, Peters A, Powers MA, Rodriguez H, Southerland P, Strock ES, Tamborlane W, Wesley DM. Recommendations for standardizing glucose reporting and analysis to optimize clinical decision making in diabetes: the Ambulatory Glucose Profile (AGP). Diabetes Technol Ther. 2013 Mar;15(3):198-211. doi: 10.1089/dia.2013.0051. Epub 2013 Feb 28. |
| 23317372 | Background | Patton SR, Clements MA, Fridlington A, Cohoon C, Turpin AL, Delurgio SA. Frequency of mealtime insulin bolus as a proxy measure of adherence for children and youths with type 1 diabetes mellitus. Diabetes Technol Ther. 2013 Feb;15(2):124-8. doi: 10.1089/dia.2012.0229. Epub 2013 Jan 14. |
| Background | Laurent J, Catanzaro SJ, Joiner TE, Rudolph KD, Potter KI, Lambert S, Gathright T. A measure of positive and negative affect for children: scale development and preliminary validation. Psychol Assess. 1999; 11: pp. 326. |
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| 17138613 | Background | Levesque CS, Williams GC, Elliot D, Pickering MA, Bodenhamer B, Finley PJ. Validating the theoretical structure of the Treatment Self-Regulation Questionnaire (TSRQ) across three different health behaviors. Health Educ Res. 2007 Oct;22(5):691-702. doi: 10.1093/her/cyl148. Epub 2006 Nov 30. |
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| Background | Fox KR, Corbin CB. The physical self-perception profile: development and preliminary validation. J Sport Exerc Psychol. 1989; 11:408-430. |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Primary | Moderate to Vigorous Physical Activity (MVPA) Levels | Participants' MVPA levels | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. | Posted | Day 1, 30 and 90 |
|
|
| Secondary | %Days That Youth Wear the Actigraph | Percent of days that youth wear the actigraph | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. | Posted | Day 1, 30 and 90 |
|
|
| Secondary | %Daily Physical Activity (PA) Schedules That Participants Complete | percent of daily PA schedules that participants complete | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. | Posted | Day 1, 30 and 90 |
|
|
| Secondary | Change in Participant HbA1c | Change in participant HbA1c | Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. | Posted | Through study completion, an average of 3.5 months |
|
|
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |