Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial

NCT02148965 | Completed

• 2 other identifiers: PAMELA-649.244Wellcome Trust - 522.064
• Study Type: interventional
• Target: 639
• Locations: 1 country
• Sites: 1

Brief Summary

The Pamela Study is a clinical trial carried out during pregnancy to assess the potential effects of physical activity during pregnancy among previously inactive women. The trial is nested into a birth cohort of more than 4000 dyads (mother-child) and took place in Pelotas, Brazil.

Conditions

Gestational Hypertension; Prematurity; Maternal Post-partum Depression; Maternal Post-partum Weight Retention; Child's Development

Keywords

motor activity; clinical trials; pregnancy; hypertension; cohort studies

Outcome Measures

Primary Outcomes (1)

• Prematurity

  By the end of the intervention, after birth, the gestational age of each child will be measured to assess the preterm birth rate.

  Women will be interviewed at hospital soon after birth (up to 2 days after delivering)

Secondary Outcomes (2)

• Maternal post-partum depression

  3 months after the end of intervention

• Child's development

  Children will be followed-up and evaluated by the ages of 3, 12 and 24 months of age

Study Arms (2)

Lifestyle intervention

EXPERIMENTAL

Physical Exercise / Physical Activity. Exercise intervention, three weekly sessions. Each session will last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling) and strength training (with focus on major muscle groups and pregnancy-specific exercises to help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary incontinence).

Behavioral: Physical Exercise / Physical Activity

Control Group

NO INTERVENTION

A group of eligible women, twice as large as the intervention group, will not receive the exercise intervention but will be followed-up equally to compare outcomes in the future.

Interventions

Physical Exercise / Physical Activity BEHAVIORAL

Lifestyle intervention Exercise intervention, three weekly sessions. Each session will last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling) and strength training (with focus on major muscle groups and pregnancy-specific exercises to help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary incontinence).

Lifestyle intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women who are at least in their 20th week of gestation, living in the city of Pelotas (Brazil), whose deliveries are due to 2015 and belonging to the 2015 Birth Cohort.

You may not qualify if:

• Hypertension
• Diabetes
• Preterm birth history
• Miscarriage history
• Heart disease
• In vitro fertilization
• Twin pregnancy
• Persistent bleeding
• Body mass index above 35kg/m2
• Heavy smokers (above 20 cigarettes/day)
• Active women (\>150 min/week of physical activity).

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Physical Education School

Pelotas, Rio Grande do Sul, 96055-630, Brazil

Location

Related Publications (3)

• Coll CVN, Domingues MR, Stein A, da Silva BGC, Bassani DG, Hartwig FP, da Silva ICM, da Silveira MF, da Silva SG, Bertoldi AD. Efficacy of Regular Exercise During Pregnancy on the Prevention of Postpartum Depression: The PAMELA Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186861. doi: 10.1001/jamanetworkopen.2018.6861.

  PMID: 30646198 DERIVED

• da Silva SG, Hallal PC, Domingues MR, Bertoldi AD, Silveira MFD, Bassani D, da Silva ICM, da Silva BGC, Coll CVN, Evenson K. A randomized controlled trial of exercise during pregnancy on maternal and neonatal outcomes: results from the PAMELA study. Int J Behav Nutr Phys Act. 2017 Dec 22;14(1):175. doi: 10.1186/s12966-017-0632-6.

  PMID: 29273044 DERIVED

• Domingues MR, Bassani DG, da Silva SG, Coll Cde V, da Silva BG, Hallal PC. Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial. Trials. 2015 May 24;16:227. doi: 10.1186/s13063-015-0749-3.

  PMID: 26003406 DERIVED

Related Links

• Epidemiology Research Center

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Premature Birth; Motor Activity; Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• PEDRO C HALLAL, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 29, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

BR (1)