NCT01790347

Brief Summary

An estimated two-thirds to three- quarters of women experience gestational weight gain outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with several maternal and fetal complications..

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,350

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
Last Updated

March 14, 2013

Status Verified

January 1, 2013

Enrollment Period

3.3 years

First QC Date

February 4, 2013

Last Update Submit

March 13, 2013

Conditions

Keywords

ExerciseAerobicResistance trainingPregnancyMaternal weight gainIOM recommendations

Outcome Measures

Primary Outcomes (1)

  • Maternal gestational weight gain

    Maternal weight gain

    40-42 weeks

Secondary Outcomes (2)

  • Maternal gestational diabetes

    From 24 to 26 week

  • Fetal body mass index

    38-42 weeks

Other Outcomes (2)

  • Gestational age

    36-42 weeks

  • Fetal outcome

    36-42 weeks

Study Arms (2)

Exercise group

EXPERIMENTAL
Behavioral: Exercise group

Control group

NO INTERVENTION

Sedentary pregnant women

Interventions

Exercise groupBEHAVIORAL

The physical conditioning program included a total of three 50-55 minute sessions per week. Pregnant women started at 9 weeks and finished at 38-39 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate. Each session included 10 min of warm up and 10 min of cool down which included an specific pelvic floor muscles training. The core section of the exercise session lasted from 25 to 30 min and included moderate-intensity aerobic exercises once a week and resistance exercises twice a week.

Exercise group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
  • Being able to communicate in spanish

You may not qualify if:

  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not being regular in physical exercise program
  • Younger than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Politécnica de Madrid

Madrid, Madrid, 28040, Spain

Location

Related Publications (1)

  • Ruiz JR, Perales M, Pelaez M, Lopez C, Lucia A, Barakat R. Supervised exercise-based intervention to prevent excessive gestational weight gain: a randomized controlled trial. Mayo Clin Proc. 2013 Dec;88(12):1388-97. doi: 10.1016/j.mayocp.2013.07.020.

MeSH Terms

Conditions

Motor ActivityGestational Weight Gain

Condition Hierarchy (Ancestors)

BehaviorWeight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ruben Barakat, PhD

    Universidad Politecnica de Madrid

    STUDY DIRECTOR

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
PhD student

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 13, 2013

Study Start

September 1, 2007

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

March 14, 2013

Record last verified: 2013-01

Locations