Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2025-12-30 @ 5:44 AM
Study NCT ID:
NCT04605406
Status:
WITHDRAWN
Last Update Posted:
2023-07-14
First Post:
2020-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daily Step Count and Achieving Goal Gestational Weight Gain
Sponsor:
Milton S. Hershey Medical Center
Organization:
Study Overview
Official Title:
Daily Step Count and Achieving Goal Gestational Weight Gain
Status:
WITHDRAWN
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants recruited for the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: