Clinical trial NCT04605406: Daily Step Count and Achieving Goal Gestational Weight Gain
Official title: Daily Step Count and Achieving Goal Gestational Weight Gain
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pregnancy Related
Keywords: pregnant
pregnancy
gestational weight
weight gain
gestational weight gain
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruited at the time of their 18-22 week second trimester ultrasound in the Obstetrics and Gynecology clinics.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Optimal average steps per day to achieve goal GWG
timeFrame: Steps per day will be measured for 7 consecutive days every 4 weeks after enrollment at the 18-22 week clinic visit until delivery at 37-41 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health
state: Pennsylvania
Study officials:
affiliation: Penn State Health
name: Serdar Ural, MD
role: PRINCIPAL_INVESTIGATOR
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