Pregnancy Related Clinical Trial
Official title:
Daily Step Count and Achieving Goal Gestational Weight Gain
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Status | Withdrawn |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 |
Verified date | July 2023 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
United States | Penn State Health | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center |
United States,
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 all — Click here to view all references
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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05017974 -
Research on Improving Sleep During Pregnancy
|
N/A | |
Completed |
NCT03284515 -
Vaccination In Pregnancy Gene Signature: VIP Signature Study
|
||
Recruiting |
NCT05969795 -
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
|
Phase 1 | |
Recruiting |
NCT06051201 -
Innovation for Small-scale Experiments: ReceptIVFity Test
|
N/A | |
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Enrolling by invitation |
NCT04527926 -
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
|
N/A | |
Recruiting |
NCT04278651 -
Early Antenatal Support for Iron Deficiency Anemia
|
Phase 4 | |
Recruiting |
NCT04405700 -
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
|
||
Recruiting |
NCT06258902 -
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
|
||
Completed |
NCT05487196 -
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
|
Phase 2 | |
Completed |
NCT03750968 -
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
|
Phase 2 | |
Enrolling by invitation |
NCT06127277 -
Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care
|
N/A | |
Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
Recruiting |
NCT05899101 -
The Impact of Opioid and Cannabis Exposure on Fetal Growth
|
||
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Completed |
NCT04296396 -
Opioid Prescription After Cesarean Trial
|
Phase 3 | |
Not yet recruiting |
NCT06069856 -
Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
Not yet recruiting |
NCT06069869 -
Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
Not yet recruiting |
NCT06079918 -
Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
|
Phase 3 | |
Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A |