Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn

Sporty Bellies - Intervention Program During Pregnancy on Women and Newborn

"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.

Study Overview

• Status: Unknown
• Conditions: Physical Activity; Depressive Symptoms; Dietary Habits; Lifestyle
• Intervention / Treatment: Other: physical exercises classes

• Study Type: Interventional
• Enrollment (Actual): 410
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Braga, Portugal
    • Universidade do Minho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The program consists in 3 physical exercise classes, one of them in the pool.	Other: physical exercises classes; 3 physical exercises classes, one of them in the pool.
No Intervention: Control Group; The control group has the basic information through health professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minho
• Collaborators: Fundação para a Ciência e a Tecnologia; Centro de Investigação em Estudos da Criança; Centro Hospitalar do Alto Ave; Câmara Municipal de Guimarães
• Investigators: Study Director: Maria B Pereira, University of Minho

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): December 31, 2017
• Study Completion (Anticipated): August 31, 2018

Study Registration Dates

• First Submitted: January 28, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 6, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Pregnancy; Physical activity; Newborn; Depressive Symptoms; Healthy lifestyles; Dietary habits
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Healthy Bellies

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No