NCT03551535

Brief Summary

The Study Investigators intend to study the adherence to and effect of a prescribed, monitored at-home exercise regimen in a pregnant population at risk for gestational diabetes, with a specific goal of understanding factors relating to adoption and performance of regular, sustained physical activity.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2019

Completed
Last Updated

September 18, 2020

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

May 3, 2018

Last Update Submit

September 16, 2020

Conditions

ExerciseMobile HealthPregnancyGestational Diabetes

Keywords

Wearable technologyPregnancyExerciseMobile Health

Outcome Measures

Primary Outcomes (1)

  • Adherence rate

    Total number of performed exercise sessions divided by prescribed exercise sessions (3 per week at minimum)

    20 weeks

Secondary Outcomes (8)

  • Gestational Diabetes

    20 weeks

  • Maternal Weight Gain

    20 weeks

  • Gestational age at delivery

    One year

  • Rate of Cesarean delivery

    One year

  • Infant weight

    One year

  • +3 more secondary outcomes

Study Arms (2)

Physical Activity Intervention

EXPERIMENTAL

Patients will be allocated to a physical activity intervention to be performed 3-5 days per week

Behavioral: Monitored, At-Home Exercise Intervention

Control

NO INTERVENTION

Patients will receive standard counseling regarding activity recommendations in pregnancy

Interventions

Monitored, At-Home Exercise InterventionBEHAVIORAL

Patients will be enrolled in the BurnAlong program as well as receive FitBit heart rate + activity monitors to track adherence rates to the prescribed exercise regimen on BurnAlong, with subsequent motivational interventions triggered if compliance varies from prescription

Physical Activity Intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant female participants only
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or greater
  • Singleton gestation
  • History of gestational diabetes
  • BMI ≥30
  • Significant family history of diabetes (two or more first degree relatives with DM)

You may not qualify if:

  • Non-English or non-Spanish speaking patients
  • Women unwilling to provide consent
  • Patients with current diagnosis of diabetes
  • Multiple gestation
  • Medical or pregnancy complications and/or comorbidities that preclude exercise in pregnancy
  • Unwillingness to commit to the prescribed exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (19)

  • National Center for Chronic Disease Prevention and Health Promotion. National Diabetes Statistics Report, 2017.

    BACKGROUND

  • Impact of physical activity during pregnancy and postpartum on chronic disease risk. Med Sci Sports Exerc. 2006 May;38(5):989-1006. doi: 10.1249/01.mss.0000218147.51025.8a.

    PMID: 16672855BACKGROUND

  • Borodulin KM, Evenson KR, Wen F, Herring AH, Benson AM. Physical activity patterns during pregnancy. Med Sci Sports Exerc. 2008 Nov;40(11):1901-8. doi: 10.1249/MSS.0b013e31817f1957.

    PMID: 18845974BACKGROUND

  • Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.

    PMID: 21694556BACKGROUND

  • World Health Organization. Global recommendations on physical activity for health. WHO (2010). Available at: http://www.who.int/dietphysicalactivity/publications/9789241599979/en. (Accessed: 23rd March 2018)

    BACKGROUND

  • Oguma Y, Shinoda-Tagawa T. Physical activity decreases cardiovascular disease risk in women: review and meta-analysis. Am J Prev Med. 2004 Jun;26(5):407-18. doi: 10.1016/j.amepre.2004.02.007.

    PMID: 15165657BACKGROUND

  • ACOG Committee Opinion No. 650: Physical Activity and Exercise During Pregnancy and the Postpartum Period. Obstet Gynecol. 2015 Dec;126(6):e135-e142. doi: 10.1097/AOG.0000000000001214.

    PMID: 26595585BACKGROUND

  • Dempsey JC, Sorensen TK, Williams MA, Lee IM, Miller RS, Dashow EE, Luthy DA. Prospective study of gestational diabetes mellitus risk in relation to maternal recreational physical activity before and during pregnancy. Am J Epidemiol. 2004 Apr 1;159(7):663-70. doi: 10.1093/aje/kwh091.

    PMID: 15033644BACKGROUND

  • Wang C, Wei Y, Zhang X, Zhang Y, Xu Q, Sun Y, Su S, Zhang L, Liu C, Feng Y, Shou C, Guelfi KJ, Newnham JP, Yang H. A randomized clinical trial of exercise during pregnancy to prevent gestational diabetes mellitus and improve pregnancy outcome in overweight and obese pregnant women. Am J Obstet Gynecol. 2017 Apr;216(4):340-351. doi: 10.1016/j.ajog.2017.01.037. Epub 2017 Feb 1.

    PMID: 28161306BACKGROUND

  • Song C, Li J, Leng J, Ma RC, Yang X. Lifestyle intervention can reduce the risk of gestational diabetes: a meta-analysis of randomized controlled trials. Obes Rev. 2016 Oct;17(10):960-9. doi: 10.1111/obr.12442. Epub 2016 Jul 15.

    PMID: 27417680BACKGROUND

  • Phelan S. Pregnancy: a "teachable moment" for weight control and obesity prevention. Am J Obstet Gynecol. 2010 Feb;202(2):135.e1-8. doi: 10.1016/j.ajog.2009.06.008. Epub 2009 Aug 15.

    PMID: 19683692BACKGROUND

  • Evenson KR, Savitz DA, Huston SL. Leisure-time physical activity among pregnant women in the US. Paediatr Perinat Epidemiol. 2004 Nov;18(6):400-7. doi: 10.1111/j.1365-3016.2004.00595.x.

    PMID: 15535815BACKGROUND

  • Gaston A, Cramp A. Exercise during pregnancy: a review of patterns and determinants. J Sci Med Sport. 2011 Jul;14(4):299-305. doi: 10.1016/j.jsams.2011.02.006. Epub 2011 Mar 21.

    PMID: 21420359BACKGROUND

  • Ning Y, Williams MA, Dempsey JC, Sorensen TK, Frederick IO, Luthy DA. Correlates of recreational physical activity in early pregnancy. J Matern Fetal Neonatal Med. 2003 Jun;13(6):385-93. doi: 10.1080/jmf.13.6.385.393.

    PMID: 12962263BACKGROUND

  • Poudevigne MS, O'Connor PJ. A review of physical activity patterns in pregnant women and their relationship to psychological health. Sports Med. 2006;36(1):19-38. doi: 10.2165/00007256-200636010-00003.

    PMID: 16445309BACKGROUND

  • Oostdam N, van Poppel MN, Wouters MG, Eekhoff EM, Bekedam DJ, Kuchenbecker WK, Quartero HW, Heres MH, van Mechelen W. No effect of the FitFor2 exercise programme on blood glucose, insulin sensitivity, and birthweight in pregnant women who were overweight and at risk for gestational diabetes: results of a randomised controlled trial. BJOG. 2012 Aug;119(9):1098-107. doi: 10.1111/j.1471-0528.2012.03366.x. Epub 2012 May 23.

    PMID: 22616913BACKGROUND

  • Olander EK, Atkinson L. Obese women's reasons for not attending a weight management service during pregnancy. Acta Obstet Gynecol Scand. 2013 Oct;92(10):1227-30. doi: 10.1111/aogs.12195. Epub 2013 Jul 5.

    PMID: 23763541BACKGROUND

  • Sui Z, Turnbull DA, Dodd JM. Overweight and obese women's perceptions about making healthy change during pregnancy: a mixed method study. Matern Child Health J. 2013 Dec;17(10):1879-87. doi: 10.1007/s10995-012-1211-8.

    PMID: 23263891BACKGROUND

  • Lau Y, Klainin-Yobas P, Htun TP, Wong SN, Tan KL, Ho-Lim ST, Chi C, Tsai C, Ong KW, Shorey S, Tam WSW. Electronic-based lifestyle interventions in overweight or obese perinatal women: a systematic review and meta-analysis. Obes Rev. 2017 Sep;18(9):1071-1087. doi: 10.1111/obr.12557. Epub 2017 May 22.

    PMID: 28544551BACKGROUND

MeSH Terms

Conditions

Motor ActivityDiabetes, Gestational

Condition Hierarchy (Ancestors)

BehaviorPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jeanne Sheffield, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2018

First Posted

June 11, 2018

Study Start

November 1, 2018

Primary Completion

October 8, 2019

Study Completion

October 8, 2019

Last Updated

September 18, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)