Daily Step Count and Achieving Goal Gestational Weight Gain
NCT ID: NCT04605406
Last Updated: 2023-07-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Study Classification
OBSERVATIONAL
Study Start Date
2023-07-31
Study Completion Date
2024-12-01
Brief Summary
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The purpose of this voluntary research study is to determine an optimal step count that aids in achieving the recommended weight gain during pregnancy and to use this count in future studies.
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Detailed Description
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The goal of this study is to contribute to the growing data that show a clear benefit in activity during pregnancy over sedentary behavior. Uniquely, this study looks to determine an optimal step count for achieving goal gestational weight gain. In doing so, this will enable clinicians to better counsel patients on a low cost, at home activity that can aid in improved maternal and fetal outcomes. This optimal step count would be used in future randomized clinical trials to determine whether this goal step count could be used to benefit other maternal and fetal outcomes such as gestational diabetes, preeclampsia, preterm labor, cesarean section rates, and birth weight.
Participation will begin at the patients 18-22 week clinic visit and will last until delivery. At the 18 - 22 week clinic visit a pedometer will be given to the patient. Patient will be instructed by a study team member to wear the pedometer on a hip for 7 days every 4 weeks and will submit daily step count for the day via a link to an online submission form which will arrive in the email once a day for 7 days in a row. An email reminder will be received every four weeks to prepare the patient for the reporting of daily step count, if no response is received electronically via the online submission form after 14 days a second reminder will be received. No change in normal activity will be required, instructions will be given to maintain normally activity during the week. The pedometer will be returned when patient arrives to labor and delivery to deliver.
The risks of this study are minimal as there will be no diversion from normal daily routine.
The results of this research may guide the future studies in walking in pregnancy in relation to maternal, fetal, and neonatal morbidity.
Participation will begin at the patients 18-22 week clinic visit and will last until delivery. At the 18 - 22 week clinic visit a pedometer will be given to the patient. Patient will be instructed by a study team member to wear the pedometer on a hip for 7 days every 4 weeks and will submit daily step count for the day via a link to an online submission form which will arrive in the email once a day for 7 days in a row. An email reminder will be received every four weeks to prepare the patient for the reporting of daily step count, if no response is received electronically via the online submission form after 14 days a second reminder will be received. No change in normal activity will be required, instructions will be given to maintain normally activity during the week. The pedometer will be returned when patient arrives to labor and delivery to deliver.
The risks of this study are minimal as there will be no diversion from normal daily routine.
The results of this research may guide the future studies in walking in pregnancy in relation to maternal, fetal, and neonatal morbidity.
Conditions
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Pregnancy Related
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
1. 18 years and older
2. Pregnant women
3. A singleton pregnancy
4. Gestational age at inclusion 18-22 weeks
5. Ability to read and speak English
6. Access to a computer
7. Cell phone
2. Pregnant women
3. A singleton pregnancy
4. Gestational age at inclusion 18-22 weeks
5. Ability to read and speak English
6. Access to a computer
7. Cell phone
Exclusion Criteria
1. Multiple pregnancy
2. Pregestational diabetes
3. Diseases limiting level of physical activity
4. Previous bariatric surgery
5. Current alcohol use
6. Current drug abuse
7. Currently in a opioid treatment program
8. History of eating disorder
9. Non-English speaking
2. Pregestational diabetes
3. Diseases limiting level of physical activity
4. Previous bariatric surgery
5. Current alcohol use
6. Current drug abuse
7. Currently in a opioid treatment program
8. History of eating disorder
9. Non-English speaking
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Milton S. Hershey Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Serdar Ural
Associate Professor of Obstetrics and Gynecology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Serdar Ural, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State Health
Locations
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Penn State Health
Hershey, Pennsylvania, United States
Site Status
Countries
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United States
References
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Bo K, Artal R, Barakat R, Brown W, Dooley M, Evenson KR, Haakstad LAH, Larsen K, Kayser B, Kinnunen TI, Mottola MF, Nygaard I, van Poppel M, Stuge B, Davies GAL; IOC Medical Commission. Exercise and pregnancy in recreational and elite athletes: 2016 evidence summary from the IOC expert group meeting, Lausanne. Part 2-the effect of exercise on the fetus, labour and birth. Br J Sports Med. 2016 Nov;50(21):1297-1305. doi: 10.1136/bjsports-2016-096810. Epub 2016 Oct 12.
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Other Identifiers
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STUDY00014096
Identifier Type: -
Identifier Source: org_study_id
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