Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn

Study Overview
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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.

Official Title
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Sporty Bellies - Intervention Program During Pregnancy on Women and Newborn

Conditions
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Lifestyle, Physical Activity, Dietary Habits, Depressive Symptoms

Intervention / Treatment
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* Other: physical exercises classes


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Physical activity, Newborn, Depressive Symptoms, Dietary habits, Healthy lifestyles