Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn

Not Applicable

• Conditions: Lifestyle; Depressive Symptoms; Physical Activity; Dietary Habits
• Interventions: Other: physical exercises classes

• Registration Number: NCT03045237
• Lead Sponsor: University of Minho

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2017-01-28
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-07
• Primary Completion: 2017-12-31
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-06
• Last Update Posted: 2018-05-08
• Study Completion: 2018-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 410

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	physical exercises classes	The program consists in 3 physical exercise classes, one of them in the pool.

Primary Outcome Measures

Name	Time	Method
Change in Depressive Symptoms assessed with the "Edinburgh Postnatal Depression Scale"	Baseline, 1 day after delivery and 1 month after delivery	Evaluation through "Edinburgh Postnatal Depression Scale"
Weight of the baby	1 day after delivery	Self-reported by participants
Length of the baby	1 day after delivery	Self-reported by participants
Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire"	Baseline and 1 month after delivery	Evaluation through "Pregnancy Physical Activity Questionnaire"
Change in Dietary intake assessed with the "Food frequency questionnaire"	Baseline and 1 month after delivery	Evaluation through "Food frequency questionnaire"
Gestational Weight gain	1 day after delivery	Values are self-reported by pregnant women

Trial Locations

Locations (1)

Universidade do Minho; 🇵🇹 Braga, Portugal