Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn

Physical Activity Clinical Trial

Official title:

Sporty Bellies - Intervention Program During Pregnancy on Women and Newborn

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03045237
• Other study ID #: Healthy Bellies
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2015
• Est. completion date: August 31, 2018

Study information

• Verified date: May 2018
• Source: University of Minho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 410
• Est. completion date: August 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Dietary Habits
• Lifestyle
• Physical Activity

Intervention

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

Locations

Country	Name	City	State
Portugal	Universidade do Minho	Braga

Sponsors (5)

Lead Sponsor	Collaborator
University of Minho	Câmara Municipal de Guimarães, Centro de Investigação em Estudos da Criança, Centro Hospitalar do Alto Ave, Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire"	Evaluation through "Pregnancy Physical Activity Questionnaire"	Baseline and 1 month after delivery
Primary	Change in Dietary intake assessed with the "Food frequency questionnaire"	Evaluation through "Food frequency questionnaire"	Baseline and 1 month after delivery
Primary	Gestational Weight gain	Values are self-reported by pregnant women	1 day after delivery
Primary	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
Primary	Weight of the baby	Self-reported by participants	1 day after delivery
Primary	Length of the baby	Self-reported by participants	1 day after delivery