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Pregnancy RelatedNCT04605406

Daily Step Count and Achieving Goal Gestational Weight Gain

An observational study of Pregnancy Related, run by Milton S. Hershey Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2023to 1 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Recruited at the time of their 18-22 week second trimester ultrasound in the Obstetrics and Gynecology clinics.

Who may be able to join

  • 18 years and older
  • Pregnant women
  • A singleton pregnancy
  • Gestational age at inclusion 18-22 weeks
  • Ability to read and speak English
  • Access to a computer
  • Cell phone

Who cannot join

  • Multiple pregnancy
  • Pregestational diabetes
  • Diseases limiting level of physical activity
  • Previous bariatric surgery
  • Current alcohol use
  • Current drug abuse
Show all 9Show fewer
  • Currently in a opioid treatment program
  • History of eating disorder
  • Non-English speaking

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Penn State Health

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

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.

Read the 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.

Keywords
pregnant, pregnancy, gestational weight, weight gain, gestational weight gain
Medical subject headings
Weight Gain, Gestational Weight Gain

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2020
  2. Study startJul 2023 (estimated)
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Why it stopped: No participants recruited for the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04605406
Sponsor's protocol ID
STUDY00014096
Status last verified
Jul 2023
First submitted
21 Oct 2020
Last updated
14 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Sharing of IPD will only be permitted when contact has been made with the Principal Investigator, Dr. Serdar Ural, and once request access to the dataset has been approved.

Publications

  • Kominiarek MA, Balmert LC, Tolo H, Grobman W, Simon M. A feasibility study of activity tracking devices in pregnancy. BMC Pregnancy Childbirth. 2019 Nov 4;19(1):401. doi: 10.1186/s12884-019-2557-3.

    PubMed 31684889

  • Kong KL, Campbell CG, Foster RC, Peterson AD, Lanningham-Foster L. A pilot walking program promotes moderate-intensity physical activity during pregnancy. Med Sci Sports Exerc. 2014 Mar;46(3):462-71. doi: 10.1249/MSS.0000000000000141.

    PubMed 24002348

  • Ferrari RM, Siega-Riz AM, Evenson KR, Moos MK, Carrier KS. A qualitative study of women's perceptions of provider advice about diet and physical activity during pregnancy. Patient Educ Couns. 2013 Jun;91(3):372-7. doi: 10.1016/j.pec.2013.01.011. Epub 2013 Feb 9.

    PubMed 23399436

  • Connolly CP, Coe DP, Kendrick JM, Bassett DR Jr, Thompson DL. Accuracy of physical activity monitors in pregnant women. Med Sci Sports Exerc. 2011 Jun;43(6):1100-5. doi: 10.1249/MSS.0b013e3182058883.

    PubMed 21085037

  • American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 548: weight gain during pregnancy. Obstet Gynecol. 2013 Jan;121(1):210-2. doi: 10.1097/01.aog.0000425668.87506.4c.

    PubMed 23262962

  • Kominiarek MA, Vyhmeister H, Balmert LC, Fairchild P, Tolo H, Grobman W, Simon M. Activity Tracking Devices in Group Prenatal Care: A Feasibility Study. Biores Open Access. 2018 Nov 28;7(1):165-176. doi: 10.1089/biores.2018.0021. eCollection 2018.

    PubMed 30505631

  • Kinnunen TI, Tennant PW, McParlin C, Poston L, Robson SC, Bell R. Agreement between pedometer and accelerometer in measuring physical activity in overweight and obese pregnant women. BMC Public Health. 2011 Jun 27;11:501. doi: 10.1186/1471-2458-11-501.

    PubMed 21703033

  • Cohen TR, Plourde H, Koski KG. Are Canadian women achieving a fit pregnancy? A pilot study. Can J Public Health. 2010 Jan-Feb;101(1):87-91. doi: 10.1007/BF03405570.

    PubMed 20364546

  • Skreden M, Overby NC, Sagedal LR, Vistad I, Torstveit MK, Lohne-Seiler H, Bere E. Change in active transportation and weight gain in pregnancy. Int J Behav Nutr Phys Act. 2016 Jan 27;13:10. doi: 10.1186/s12966-016-0332-7.

    PubMed 26818593

  • Westgarth C, Liu J, Heron J, Ness AR, Bundred P, Gaskell RM, German AJ, McCune S, Dawson S. Dog ownership during pregnancy, maternal activity, and obesity: a cross-sectional study. PLoS One. 2012;7(2):e31315. doi: 10.1371/journal.pone.0031315. Epub 2012 Feb 15.

    PubMed 22355356

  • Cremona A, O'Gorman C, Cotter A, Saunders J, Donnelly A. Effect of exercise modality on markers of insulin sensitivity and blood glucose control in pregnancies complicated with gestational diabetes mellitus: a systematic review. Obes Sci Pract. 2018 Sep 4;4(5):455-467. doi: 10.1002/osp4.283. eCollection 2018 Oct.

    PubMed 30338116

  • McMillan AG, May LE, Gaines GG, Isler C, Kuehn D. Effects of Aerobic Exercise during Pregnancy on 1-Month Infant Neuromotor Skills. Med Sci Sports Exerc. 2019 Aug;51(8):1671-1676. doi: 10.1249/MSS.0000000000001958.

    PubMed 30817721

  • Lemmens PMC, Sartor F, Cox LGE, den Boer SV, Westerink JHDM. Evaluation of an activity monitor for use in pregnancy to help reduce excessive gestational weight gain. BMC Pregnancy Childbirth. 2018 Jul 31;18(1):312. doi: 10.1186/s12884-018-1941-8.

    PubMed 30064390

  • Bo K, Artal R, Barakat R, Brown W, Davies GA, Dooley M, Evenson KR, Haakstad LA, Henriksson-Larsen K, Kayser B, Kinnunen TI, Mottola MF, Nygaard I, van Poppel M, Stuge B, Khan KM. Exercise and pregnancy in recreational and elite athletes: 2016 evidence summary from the IOC expert group meeting, Lausanne. Part 1-exercise in women planning pregnancy and those who are pregnant. Br J Sports Med. 2016 May;50(10):571-89. doi: 10.1136/bjsports-2016-096218. No abstract available.

    PubMed 27127296

  • 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.

    PubMed 27733352

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy Related, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optimal average steps per day to achieve goal GWG (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04605406, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.

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