Daily Step Count and Achieving Goal Gestational Weight Gain

NCT04605406 | Withdrawn

• 1 other identifier: STUDY00014096
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

pregnant; pregnancy; gestational weight; weight gain; gestational weight gain

Outcome Measures

Primary Outcomes (1)

• Optimal average steps per day to achieve goal GWG

  Assessing the optimal average steps per day a pregnant woman should take to meet her goal gestational weight gain (GWG) based on ACOG guidelines. Meeting the goal GWG is defined as a yes/no response.

  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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years and older
• Pregnant women
• A singleton pregnancy
• Ability to read and speak English
• Access to a computer
• Cell phone

You may not qualify if:

• Multiple pregnancy
• Pregestational diabetes
• Diseases limiting level of physical activity
• Previous bariatric surgery
• Current alcohol use
• Current drug abuse
• Currently in a opioid treatment program
• History of eating disorder
• Non-English speaking

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Health

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (40)

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MeSH Terms

Conditions

Weight Gain; Gestational Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serdar Ural, MD

  Penn State Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 28, 2020
• Study Start: July 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Length of time to complete the outcomes, estimating 6 months.

Locations

US (1)