Clinical trial NCT03045237: Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn
Official title: Sporty Bellies - Intervention Program During Pregnancy on Women and Newborn
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lifestyle
Physical Activity
Dietary Habits
Depressive Symptoms
Keywords: Pregnancy
Physical activity
Newborn
Depressive Symptoms
Dietary habits
Healthy lifestyles
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: Centro de Investigação em Estudos da Criança
name: Centro Hospitalar do Alto Ave
name: Câmara Municipal de Guimarães
First posted: 2017-02-07
Enrollment: 410
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in physical activity assessed with the "Pregnancy Physical Activity Questionnaire"
timeFrame: Baseline and 1 month after delivery
measure: Change in Dietary intake assessed with the "Food frequency questionnaire"
timeFrame: Baseline and 1 month after delivery
measure: Gestational Weight gain
timeFrame: 1 day after delivery
measure: Change in Depressive Symptoms assessed with the "Edinburgh Postnatal Depression Scale"
timeFrame: Baseline, 1 day after delivery and 1 month after delivery
measure: Weight of the baby
timeFrame: 1 day after delivery
measure: Length of the baby
timeFrame: 1 day after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Universidade do Minho
Study officials:
affiliation: University of Minho
name: Maria B Pereira
role: STUDY_DIRECTOR
References: