Daily Step Count and Achieving Goal Gestational Weight Gain

Pregnancy Related Clinical Trial

Official title:

Daily Step Count and Achieving Goal Gestational Weight Gain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04605406
• Other study ID #: STUDY00014096
• Status: Withdrawn
• Start date: July 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gestational Weight Gain
• Pregnancy Related
• Weight Gain

Locations

Country	Name	City	State
United States	Penn State Health	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.