Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn

NCT ID: NCT03045237

Last Updated: 2018-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-01

Study Completion Date

2018-08-31

Brief Summary

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"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.

Detailed Description

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Conditions

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Lifestyle Physical Activity Dietary Habits Depressive Symptoms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

physical exercises classes

Intervention Type OTHER

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

Control Group

The control group has the basic information through health professionals.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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physical exercises classes

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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);
* history of extremely sedentary lifestyle;
* intrauterine growth restriction in current pregnancy;
* poorly controlled hypertension/pre-eclampsia;
* orthopaedic limitations;
* poorly controlled seizure disorder;
* poorly controlled thyroid disease; heavy smoker).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role collaborator

Centro de Investigação em Estudos da Criança

UNKNOWN

Sponsor Role collaborator

Centro Hospitalar do Alto Ave

UNKNOWN

Sponsor Role collaborator

Câmara Municipal de Guimarães

UNKNOWN

Sponsor Role collaborator

University of Minho

OTHER

Sponsor Role lead

Responsible Party

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Ana Isabel Teixeira Jesus Silva

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria B Pereira

Role: STUDY_DIRECTOR

University of Minho

Locations

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Universidade do Minho

Braga, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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Healthy Bellies

Identifier Type: -

Identifier Source: org_study_id

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