Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 320
- Locations
- 2
- Primary Endpoint
- Maternal weight gain
Study Overview
Brief Summary
The purpose of this study was to assess the effectiveness of a moderated physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes and on the perception of the pregnant's health
Detailed Description
BACKROUND: Pregnancy and delivery can condition significantly women's health. In particular, an excessive gain of weight during pregnancy constitutes a risk factor which may lead to (i) different alterations during pregnancy such as gestational diabetes or hypertension, (ii) foetus health problems (macrosomia), (iii) delivery complications (dystocia, prolonged labour and increased number of caesareans) and (iv) future health disorders for the woman (overweight, obesity and cardiovascular alterations). Furthermore, during pregnancy pelvic floor health problems, such as urinary incontinence (IU) may arise or worsen.
OBJECTIVES: The main aim of this study was to assess the effectiveness of a moderate physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes (maternal and foetal) and on the perception of the pregnant's health.
DESIGN: A randomized, controlled trial called has been conducted. 300 healthy pregnant women were recruited and divided into an intervention group (IG, n=100) and a control group (CG, n=200). The IG participated in BEP as from week 10-12 of gestation (at least 56 sessions through 22 weeks. 3 sessions per week). The CG did not participate in any supervised program addressed to pregnant women but received regular health care. Pregnancy outcomes regarding the mother and the new born, urinary incontinence and women's habits data were obtained and registered through initial interviews, medical records and two specific questionnaires on health and urinary incontinency (ICIQ-SF and King's).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy pregnant women
- •Delivering in "Hospital Universitario de Fuenlabrada"
- •At week 10-14 of gestation
- •Able to attend 3 sessions per week until the end of the pregnancy
Exclusion Criteria
- •Contraindications appointed by ACOG
- •Less than 56 sessions
Outcomes
Primary Outcomes
Maternal weight gain
Time Frame: week 36-38 of gestation
Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations
Secondary Outcomes
- Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)(week 36-38 of gestation)
- Urinary incontinence(week 36-38 of gestation)
- Other pregnancy outcomes (maternal and foetal)(week 36-38 of gestation)
Investigators
Ruben Barakat Carballo
Director
Universidad Politecnica de Madrid