NCT03405649

Brief Summary

Among the well-known factors that contribute to the development of obesity, childbearing has been reported as an important influential factor. Physical activity is strongly recommended as one of the main tools to reduce any excessive weight gain during pregnancy and also to reduce weight retention in the postpartum period. During the postpartum period, exercise training coupled with a well-balanced nutritional plan, offers an effective intervention to help mothers lose weight safely. International guidelines for physical activity after pregnancy include strengthening routines. Worth noting, most of the above cited studies focused on the benefits of aerobic activities. Strength training interventions are virtually unexplored in postpartum women despite its potential benefits. Compared to the pregnancy period, postpartum barriers to physical activity seem to focus less on health-related barriers. In postpartum, time limitations for childcare become a more common barrier. For this reason, a postpartum exercise program that incorporates the babies in a specific exercise session has a better chance to succeed. The aim of this project is to determine the benefits of strength training in a group class setting in postpartum healthy women with their babies. Whereas mother's participation in regular physical activity may encourage regular physical activity habits in her offspring, a second aim of this project is to also quantify the infant's physical activity. The main measured outcomes are: maternal muscular strength; body composition; aerobic capacity; exercise self efficacy; depressive symptoms; physical activity level and food habits and baby's physical activity level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

August 2, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

2.4 years

First QC Date

January 5, 2018

Last Update Submit

April 5, 2021

Conditions

Keywords

postpartumexerciseintervention

Outcome Measures

Primary Outcomes (1)

  • Maternal overall muscular strength

    A series of muscular strength assessments will be performed at baseline, after 5 weeks and at 10 weeks of intervention. Higher number of timed push-ups, squats and sit-ups increased from baseline will indicate improved muscular strength.

    10 weeks

Secondary Outcomes (7)

  • Maternal body composition

    10 weeks

  • Maternal aerobic capacity

    10 weeks

  • Maternal physical activity level measured by the International Physical Activity Questionnaire (IPAQ)

    10 weeks

  • Maternal self-efficacy

    10 weeks

  • Maternal eating habits

    10 weeks

  • +2 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

Participants train 60 min per session for 10 weeks on non-consecutive days. All training sessions will be supervised by a qualified exercise instructor. Each training session will include a warm up phase of 5 minutes of dynamic and static stretching and a cool down phase consisting of 5 minutes of static stretching. Whole-body exercises and weights, elastic bands and balls will be used. Babies less than 20 weeks of age will be included in the exercise routine. Participants will perform 1-3 sets per exercise, 8-12 repetitions per set and a 90-s rest interval between sets.

Behavioral: Group A

Group B

EXPERIMENTAL

Participants train 60 min per session for 10 weeks on non consecutive days. All training sessions will be supervised by a qualified exercise instructor. Each training session will include a warm up phase of 5 minutes of dynamic and static stretching and a cool down phase consisting of 5 minutes of static stretching. Whole-body exercises and different equipment such as weights, elastic bands and balls will be used. Babies older than 20 weeks will be included in the exercise routine. Participants will perform 1-3 sets per exercise, 8-12 repetitions per set and a 90-s rest interval between sets.

Behavioral: Group B

Interventions

Group ABEHAVIORAL

Muscle conditioning exercise for postpartum women and infants less than 20 weeks of age.

Group A
Group BBEHAVIORAL

Muscle conditioning exercise for postpartum women and infants more than 20 weeks of age.

Group B

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum women and their infants of both sexes.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy (free from chronic diseases) women between 8 weeks and 50 weeks after delivery.

You may not qualify if:

  • Inability to perform strength training or moderate-intensity exercise, athletes/well trained mothers (i.e. mothers undergoing regular strength training), smokers and women who are planning to become pregnant over the subsequent year. Women who cannot read, write and understand English will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise and Pregnancy Lab, 2245, 3-M Centre - University of Western Ontario

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Michelle F Mottola, PhD

    University of Western Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Women contacting the lab will be divided into those women who have babies less than 20 weeks of age (Group A) and those whose babies are greater than 20 weeks of age (Group B). Each of these groups will be given a separate postpartum exercise program that will run concurrently. These groups were divided by baby age because we felt early postpartum women and babies are a different group than those women with babies 6 months and older.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 23, 2018

Study Start

August 2, 2018

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

De-identified participant data for primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data will be made available within 1 year of study completion.
Access Criteria
Data access requests will be reviewed by an independent review panel. Requestors will be required to sign a data access agreement and privacy statement.

Locations