NCT03045237

Brief Summary

"Healthy Bellies" is an intervention program with pregnant women, based on the promotion of healthy lifestyles. It aims to evaluate the impact of the program in the health of both pregnant and newborn. This trial is being conducted with pregnant women, divided into control and intervention group. Are performed 3 assessment periods: 1 - beginning of the program; 2 - postpartum; 3 - 1 month after delivery. The intervention group has a program of 3 weekly physical exercise classes and the control group has the basic information that is usually provided by health professionals. With this program, it is expected to contribute with evidence to the best practice in the field of interventions in pregnancy and improve health outcomes of both pregnant and newborn.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

January 28, 2017

Last Update Submit

May 6, 2018

Conditions

LifestylePhysical ActivityDietary HabitsDepressive Symptoms

Keywords

PregnancyPhysical activityNewbornDepressive SymptomsDietary habitsHealthy lifestyles

Outcome Measures

Primary Outcomes (6)

  • Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire"

    Evaluation through "Pregnancy Physical Activity Questionnaire"

    Baseline and 1 month after delivery

  • Change in Dietary intake assessed with the "Food frequency questionnaire"

    Evaluation through "Food frequency questionnaire"

    Baseline and 1 month after delivery

  • Gestational Weight gain

    Values are self-reported by pregnant women

    1 day after delivery

  • Change in Depressive Symptoms assessed with the "Edinburgh Postnatal Depression Scale"

    Evaluation through "Edinburgh Postnatal Depression Scale"

    Baseline, 1 day after delivery and 1 month after delivery

  • Weight of the baby

    Self-reported by participants

    1 day after delivery

  • Length of the baby

    Self-reported by participants

    1 day after delivery

Study Arms (2)

Intervention Group

EXPERIMENTAL

The program consists in 3 physical exercise classes, one of them in the pool.

Other: physical exercises classes

Control Group

NO INTERVENTION

The control group has the basic information through health professionals.

Interventions

physical exercises classesOTHER

3 physical exercises classes, one of them in the pool.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Do not have any medical or obstetric contraindication for physical exercise

You may not qualify if:

  • Haemodynamically significant heart disease;
  • restrictive lung disease;
  • incompetent cervix/cerclage;
  • multiple gestation at risk for premature labor;
  • persistent second or third trimester bleeding;
  • placenta praevia after 26 weeks gestation;
  • premature labor during the current pregnancy;
  • ruptured membranes;
  • pregnancy induced hypertension;
  • severe anaemia;
  • unevaluated maternal cardiac arrhythmia;
  • chronic bronchitis;
  • poorly controlled type I diabetes;
  • extreme morbid obesity;
  • extreme underweight (body mass index \<12);
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade do Minho

Braga, Portugal

Location

MeSH Terms

Conditions

Motor ActivityFeeding BehaviorDepression

Condition Hierarchy (Ancestors)

BehaviorBehavior, AnimalBehavioral Symptoms

Study Officials

  • Maria B Pereira

    University of Minho

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

January 28, 2017

First Posted

February 7, 2017

Study Start

November 1, 2015

Primary Completion

December 31, 2017

Study Completion

August 31, 2018

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

PT(1)