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Monitored Home Exercise in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03551535
Recruitment Status : Withdrawn (Study IRB approval expired)
First Posted : June 11, 2018
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Exercise Mobile Health Pregnancy Gestational Diabetes Behavioral: Monitored, At-Home Exercise Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Feasibility and Adherence of a Prescribed, Monitored Home Exercise Program in High Risk Pregnant Women
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : October 8, 2019
Actual Study Completion Date : October 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical Activity Intervention
Patients will be allocated to a physical activity intervention to be performed 3-5 days per week
Behavioral: Monitored, At-Home Exercise Intervention
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

No Intervention: Control
Patients will receive standard counseling regarding activity recommendations in pregnancy



Primary Outcome Measures :
  1. Adherence rate [ Time Frame: 20 weeks ]
    Total number of performed exercise sessions divided by prescribed exercise sessions (3 per week at minimum)


Secondary Outcome Measures :
  1. Gestational Diabetes [ Time Frame: 20 weeks ]
    Development of Gestational diabetes as determined by routine 1 hour and then subsequent 3 hour glucose testing results

  2. Maternal Weight Gain [ Time Frame: 20 weeks ]
    measured in kilograms

  3. Gestational age at delivery [ Time Frame: One year ]
    Infant's gestational age at delivery

  4. Rate of Cesarean delivery [ Time Frame: One year ]
    measured as the number of cesarean deliveries per total number of deliveries

  5. Infant weight [ Time Frame: One year ]
    Infant weight in grams measured post delivery

  6. Neonatal Apgar scores [ Time Frame: 1, 5, and 10 minutes of neonatal life ]
    An assessment of neonatal wellbeing measured at 1, 5, and 10 minutes post-delivery, and is measured on a scale of 0-9, with 9 being the highest, and 0 being the lowest.

  7. Neonatal Intensive Care Unit (NICU) Admission Rate [ Time Frame: One year ]
    Rate of admission of infants post-delivery to the NICU

  8. Neonatal hypoglycemia rates [ Time Frame: One year ]
    Number of infants with hypoglycemia divided by the total number of delivered infants



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant female participants only
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551535


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Jeanne Sheffield, MD Johns Hopkins University
Publications:
National Center for Chronic Disease Prevention and Health Promotion. National Diabetes Statistics Report, 2017.
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)
American College of Obstetricians and Gynecologists. ACOG Committee Opinion 650: Physical Activity and Exercise During Pregnancy and Postpartum Period. (2015).

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03551535    
Other Study ID Numbers: IRB00173362
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Wearable technology
Pregnancy
Exercise
Mobile Health
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases