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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04605406
Other study ID # STUDY00014096
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)

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. — View Citation

Bacchi E, Bonin C, Zanolin ME, Zambotti F, Livornese D, Dona S, Tosi F, Baldisser G, Ihnatava T, Di Sarra D, Bonora E, Moghetti P. Physical Activity Patterns in Normal-Weight and Overweight/Obese Pregnant Women. PLoS One. 2016 Nov 9;11(11):e0166254. doi: 10.1371/journal.pone.0166254. eCollection 2016. — View Citation

Baruth M, Schlaff RA, Deere S, Walker JL, Dressler BL, Wagner SF, Boggs A, Simon HA. The Feasibility and Efficacy of a Behavioral Intervention to Promote Appropriate Gestational Weight Gain. Matern Child Health J. 2019 Dec;23(12):1604-1612. doi: 10.1007/s10995-019-02812-6. — View Citation

Berghella V, Saccone G. Exercise in pregnancy! Am J Obstet Gynecol. 2017 Apr;216(4):335-337. doi: 10.1016/j.ajog.2017.01.023. Epub 2017 Feb 22. No abstract available. — View Citation

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. — View Citation

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. — View Citation

Chandonnet N, Saey D, Almeras N, Marc I. French Pregnancy Physical Activity Questionnaire compared with an accelerometer cut point to classify physical activity among pregnant obese women. PLoS One. 2012;7(6):e38818. doi: 10.1371/journal.pone.0038818. Epub 2012 Jun 11. — View Citation

Cohen TR, Koski KG. Limiting excess weight gain in healthy pregnant women: importance of energy intakes, physical activity, and adherence to gestational weight gain guidelines. J Pregnancy. 2013;2013:787032. doi: 10.1155/2013/787032. Epub 2013 Feb 20. — View Citation

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. — View Citation

Cohen TR, Plourde H, Koski KG. Use of the Pregnancy Physical Activity Questionnaire (PPAQ) to identify behaviours associated with appropriate gestational weight gain during pregnancy. J Phys Act Health. 2013 Sep;10(7):1000-7. doi: 10.1123/jpah.10.7.1000. Epub 2012 Nov 5. — View Citation

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. — View Citation

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. — View Citation

DiNallo JM, Downs DS, Le Masurier G. Objectively assessing treadmill walking during the second and third pregnancy trimesters. J Phys Act Health. 2012 Jan;9(1):21-8. doi: 10.1123/jpah.9.1.21. — View Citation

Dodd JM, Cramp C, Sui Z, Yelland LN, Deussen AR, Grivell RM, Moran LJ, Crowther CA, Turnbull D, McPhee AJ, Wittert G, Owens JA, Robinson JS; LIMIT Randomised Trial Group. The effects of antenatal dietary and lifestyle advice for women who are overweight or obese on maternal diet and physical activity: the LIMIT randomised trial. BMC Med. 2014 Oct 13;12:161. doi: 10.1186/s12916-014-0161-y. — View Citation

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. — View Citation

Haby K, Berg M, Gyllensten H, Hanas R, Premberg A. Mighty Mums - a lifestyle intervention at primary care level reduces gestational weight gain in women with obesity. BMC Obes. 2018 Jun 4;5:16. doi: 10.1186/s40608-018-0194-4. eCollection 2018. — View Citation

Haby K, Glantz A, Hanas R, Premberg A. Mighty Mums - An antenatal health care intervention can reduce gestational weight gain in women with obesity. Midwifery. 2015 Jul;31(7):685-92. doi: 10.1016/j.midw.2015.03.014. Epub 2015 Apr 9. — View Citation

Harrison CL, Thompson RG, Teede HJ, Lombard CB. Measuring physical activity during pregnancy. Int J Behav Nutr Phys Act. 2011 Mar 21;8:19. doi: 10.1186/1479-5868-8-19. — View Citation

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. — View Citation

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. — View Citation

Kominiarek MA, Peaceman AM. Gestational weight gain. Am J Obstet Gynecol. 2017 Dec;217(6):642-651. doi: 10.1016/j.ajog.2017.05.040. Epub 2017 May 24. — View Citation

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. — View Citation

Kong KL, Campbell C, Wagner K, Peterson A, Lanningham-Foster L. Impact of a walking intervention during pregnancy on post-partum weight retention and infant anthropometric outcomes. J Dev Orig Health Dis. 2014 Jun;5(3):259-67. doi: 10.1017/S2040174414000117. — View Citation

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. — View Citation

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. — View Citation

Materia FT, Smyth JM, Heron KE, Hillemeier M, Feinberg ME, Fonzi P, Symons Downs D. Preconceptional health behavior change in women with overweight and obesity: prototype for SMART strong healthy women intervention. Mhealth. 2018 Jul 6;4:24. doi: 10.21037/mhealth.2018.06.06. eCollection 2018. — View Citation

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. — View Citation

McParlin C, Robson SC, Tennant PW, Besson H, Rankin J, Adamson AJ, Pearce MS, Bell R. Objectively measured physical activity during pregnancy: a study in obese and overweight women. BMC Pregnancy Childbirth. 2010 Nov 29;10:76. doi: 10.1186/1471-2393-10-76. — View Citation

Medek H, Halldorsson T, Gunnarsdottir I, Geirsson RT. Physical activity of relatively high intensity in mid-pregnancy predicts lower glucose tolerance levels. Acta Obstet Gynecol Scand. 2016 Sep;95(9):1055-62. doi: 10.1111/aogs.12931. Epub 2016 Jun 9. — View Citation

Mottola MF, Davenport MH, Ruchat SM, Davies GA, Poitras V, Gray C, Jaramillo Garcia A, Barrowman N, Adamo KB, Duggan M, Barakat R, Chilibeck P, Fleming K, Forte M, Korolnek J, Nagpal T, Slater L, Stirling D, Zehr L. No. 367-2019 Canadian Guideline for Physical Activity throughout Pregnancy. J Obstet Gynaecol Can. 2018 Nov;40(11):1528-1537. doi: 10.1016/j.jogc.2018.07.001. Epub 2018 Oct 5. Erratum In: J Obstet Gynaecol Can. 2019 Jul;41(7):1067. — View Citation

Nascimento SL, Surita FG, Godoy AC, Kasawara KT, Morais SS. Physical Activity Patterns and Factors Related to Exercise during Pregnancy: A Cross Sectional Study. PLoS One. 2015 Jun 17;10(6):e0128953. doi: 10.1371/journal.pone.0128953. eCollection 2015. Erratum In: PLoS One. 2015;10(7):e0133564. — View Citation

Renault K, Norgaard K, Andreasen KR, Secher NJ, Nilas L. Physical activity during pregnancy in obese and normal-weight women as assessed by pedometer. Acta Obstet Gynecol Scand. 2010 Jul;89(7):956-61. doi: 10.3109/00016341003792459. — View Citation

Renault K, Norgaard K, Secher NJ, Andreasen KR, Baldur-Felskov B, Nilas L. Physical activity during pregnancy in normal-weight and obese women: compliance using pedometer assessment. J Obstet Gynaecol. 2012 Jul;32(5):430-3. doi: 10.3109/01443615.2012.668580. — View Citation

Renault KM, Norgaard K, Nilas L, Carlsen EM, Cortes D, Pryds O, Secher NJ. The Treatment of Obese Pregnant Women (TOP) study: a randomized controlled trial of the effect of physical activity intervention assessed by pedometer with or without dietary intervention in obese pregnant women. Am J Obstet Gynecol. 2014 Feb;210(2):134.e1-9. doi: 10.1016/j.ajog.2013.09.029. Epub 2013 Sep 20. — View Citation

Shieh C, Draucker CB. Self-monitoring Lifestyle Behavior in Overweight and Obese Pregnant Women: Qualitative Findings. Clin Nurse Spec. 2018 Mar/Apr;32(2):81-89. doi: 10.1097/NUR.0000000000000355. — View Citation

Shieh C, Yang Z, Haas DM, Carpenter JS. Feasibility and Potential Benefits of a Self-Monitoring Enhanced Lifestyle Intervention to Prevent Excessive Gestational Weight Gain in Women Who Are Overweight or Obese. J Obstet Gynecol Neonatal Nurs. 2017 Mar-Apr;46(2):182-196. doi: 10.1016/j.jogn.2016.09.006. Epub 2017 Jan 5. — View Citation

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. — View Citation

Viecceli C, Remonti LR, Hirakata VN, Mastella LS, Gnielka V, Oppermann ML, Silveiro SP, Reichelt AJ. Weight gain adequacy and pregnancy outcomes in gestational diabetes: a meta-analysis. Obes Rev. 2017 May;18(5):567-580. doi: 10.1111/obr.12521. Epub 2017 Mar 8. — View Citation

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. — View Citation

Yeo S, Logan JG. Preventing obesity: exercise and daily activities of low-income pregnant women. J Perinat Neonatal Nurs. 2014 Jan-Mar;28(1):17-25. doi: 10.1097/JPN.0000000000000000. Erratum In: J Perinat Neonatal Nurs. 2014 Apr-Jun;28(2):156. — View Citation

* Note: There are 40 references in allClick 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.
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