CClinicalTrials.gg
TerminatedNCT06018844Updated Aug 19, 2025Results posted

Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus

An observational study in Type 1 Diabetes, sponsored by Children's Mercy Hospital Kansas City. Terminated at 1 site in United States. Open to participants aged 13 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-08-19.

Sponsored by Children's Mercy Hospital Kansas City · Observational

Why this study was terminated
PI decision based on reduced staffing and funds.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1
Ages
13 Years to 21 Years
Sex
All
01

Study summary

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:

  • Does the intervention increase the amount of text messages between the mHealth software and participants?
  • Do the text messages from the Nudge software increase moderate to vigorous physical activity (MVPA) in participants?
  • Does the MVPA encouraged by the Nudge software improve the HbA1c levels of participants?

Participants will:

  • Receive text messages from the Nudge software
  • Report physical activity goals via the text messages to the Nudge software
  • Wear both an accelerometer and an actigraph for three weeks (spread out across the beginning, 30 days, and 90 days of participation)
  • Complete surveys at the beginning of participation
  • Complete daily surveys while wearing the devices
  • Complete surveys at the end of participation
  • Record physical activity in study surveys
02

Conditions studied

  • Type 1 Diabetes
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's enrollment of 1 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients 12.00 to 21.99 with Type 1 Diabetes

Inclusion criteria

  • Participants 12.00-21.99 years old
  • Participants with a physician confirmed T1D diagnosis.
  • T1D diagnosis was at least 6 months prior to study enrollment
  • Participants are on an intensive insulin regiment (either with an insulin pump or multiple daily injection)
  • Participants must be using a continuous glucose monitor (CGM)
  • Participants and parents/legally authorized representatives (LARS) of participants less than 18.00 speak/read English.

Exclusion criteria

Exclusion Criteria:

  • Participants with evidence of type 2 or monogenic diabetes.
  • Participants with a comorbid chronic condition (e.g., renal disease).
  • Participants with presence of severe psychiatric disorders.
  • Participants with a diagnosis of low vision (vision that cannot be corrected with contact lenses or eyeglasses).
  • Participants with limited mobility that would prevent participant from engaging in daily physical activity, self-assessed by participant.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1 participant (actual)
Patient registry
No

Interventions

  • OtherNUDGE

    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.

06

What researchers measure

Primary outcomes

  1. %Daily Text Messages Exchanged Between Youth and the NUDGE Bot

    percent of daily text messages exchanged between youth and the NUDGE bot

    Time frame: Through study completion, an average of 3.5 months

  2. Moderate to Vigorous Physical Activity (MVPA) Levels

    Participants' MVPA levels

    Time frame: Day 1, 30 and 90

Secondary outcomes

  1. %Days That Youth Wear the Actigraph

    Percent of days that youth wear the actigraph

    Time frame: Day 1, 30 and 90

  2. %Daily Physical Activity (PA) Schedules That Participants Complete

    percent of daily PA schedules that participants complete

    Time frame: Day 1, 30 and 90

  3. Change in Participant HbA1c

    Change in participant HbA1c

    Time frame: Through study completion, an average of 3.5 months

07

Results

Posted Aug 19, 2025

Participant flow

Participant flow — Overall Study
MilestonePrimary Arm
Started1
Completed0
Not completed1

Outcome measures

Primary%Daily Text Messages Exchanged Between Youth and the NUDGE Bot

percent of daily text messages exchanged between youth and the NUDGE bot

Time frame:
Through study completion, an average of 3.5 months

No measurements were reported for this outcome.

PrimaryModerate to Vigorous Physical Activity (MVPA) Levels

Participants' MVPA levels

Time frame:
Day 1, 30 and 90

No measurements were reported for this outcome.

Secondary%Days That Youth Wear the Actigraph

Percent of days that youth wear the actigraph

Time frame:
Day 1, 30 and 90

No measurements were reported for this outcome.

Secondary%Daily Physical Activity (PA) Schedules That Participants Complete

percent of daily PA schedules that participants complete

Time frame:
Day 1, 30 and 90

No measurements were reported for this outcome.

SecondaryChange in Participant HbA1c

Change in participant HbA1c

Time frame:
Through study completion, an average of 3.5 months

No measurements were reported for this outcome.

Adverse events

Collected over 11 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Primary Arm0/1 (0%)0/1 (0%)0/1 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Primary Arm
Mean17 (17 to 17)
Sex: Female, Male
Sex: Female, Male(Participants)Primary Arm
Female1
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Primary Arm
Hispanic or Latino0
Not Hispanic or Latino1
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Primary Arm
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White1
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Children's Mercy
    Kansas City, Missouri 64111, United States
09

References and documents

Publications

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  • 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. PubMed 17327312 ↗
  • 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. PubMed 28723318 ↗
  • 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. PubMed 27044668 ↗
  • 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. PubMed 31862756 ↗
  • 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. PubMed 28126459 ↗
  • 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. PubMed 24508755 ↗
  • 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. PubMed 24444038 ↗
  • 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. PubMed 27475093 ↗
  • 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. PubMed 28131985 ↗
  • Lenhart, A. (2015). Teens, Social Media, & Technology Overview. Retrieved from http://pewinternet.org/2015/04/09/teens-social-media-technology-2015/
  • 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. PubMed 28319239 ↗
  • 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. PubMed 25576494 ↗
  • 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. PubMed 25502745 ↗
  • 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. PubMed 19916637 ↗
  • 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. PubMed 26429638 ↗
  • 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. PubMed 33484137 ↗
  • 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. PubMed 7134324 ↗
  • 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. PubMed 20392790 ↗
  • 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. PubMed 23448694 ↗
  • 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. PubMed 23317372 ↗
  • 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.
  • Terry PC, Lane AM, Lane HJ, Keohane L. Development and validation of a mood measure for adolescents. J Sports Sci. 1999 Nov;17(11):861-72. doi: 10.1080/026404199365425. PubMed 10585166 ↗
  • 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. PubMed 17138613 ↗
  • Nelson TD, Benson ER, Jensen CD. Negative attitudes toward physical activity: measurement and role in predicting physical activity levels among preadolescents. J Pediatr Psychol. 2010 Jan-Feb;35(1):89-98. doi: 10.1093/jpepsy/jsp040. Epub 2009 May 15. PubMed 19447878 ↗
  • Fox KR, Corbin CB. The physical self-perception profile: development and preliminary validation. J Sport Exerc Psychol. 1989; 11:408-430.
  • Duncan TE, McAuley E. Social support and efficacy cognitions in exercise adherence: a latent growth curve analysis. J Behav Med. 1993 Apr;16(2):199-218. doi: 10.1007/BF00844893. PubMed 8315646 ↗
  • Motl RW, Dishman RK, Trost SG, Saunders RP, Dowda M, Felton G, Ward DS, Pate RR. Factorial validity and invariance of questionnaires measuring social-cognitive determinants of physical activity among adolescent girls. Prev Med. 2000 Nov;31(5):584-94. doi: 10.1006/pmed.2000.0735. PubMed 11071840 ↗
  • Lowe MR, Butryn ML, Didie ER, Annunziato RA, Thomas JG, Crerand CE, Ochner CN, Coletta MC, Bellace D, Wallaert M, Halford J. The Power of Food Scale. A new measure of the psychological influence of the food environment. Appetite. 2009 Aug;53(1):114-8. doi: 10.1016/j.appet.2009.05.016. Epub 2009 Jun 12. PubMed 19500623 ↗
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  • Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available. PubMed 10245370 ↗
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Study documents

  • Protocol and statistical analysis plan · May 22, 2024
  • Informed consent form · Jul 16, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06018844
Lead sponsor
Children's Mercy Hospital Kansas City
Collaborators
University of Kansas, Nemours Children's Clinic
Responsible party
Sponsor
First posted
Aug 31, 2023
Start date
Jul 25, 2024
Primary completion
Jun 26, 2025
Completion
Jun 26, 2025
Results posted
Aug 19, 2025
Last update
Aug 19, 2025

Study contacts

Mark Clements, MD
principal investigator · Children's Mercy

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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