Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women
NCT01329835 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180
Last updated 2011-12-06
Summary
Prepregnancy obesity, defined as a body mass index (BMI) of 30kg/m² or more, shows a strong association with pregnancy and birth complications for both the mother and her child. Most consequently reported maternal risks include an increased risk for gestational diabetes, hypertension and pre-eclampsia, increased incidence of induction of labour, operative delivery, postpartum haemorrhage, anaesthetic risks as well as risk for infections and thromboembolic complications. Fetal risks include miscarriage, neural-tube defects, heart defects, macrosomia and stillbirth. Initiation and continuation of breastfeeding is more complicated in obese women than in normal weight women. Also in later life chronic diseases can put the mother and her baby's health at risk. The Institute Of Medicine (IOM) guidelines suggest a gestational weight gain (GWG) to be limited to 5 - 9 kg (11-19,8 lb) in obese women in order to minimize the synergetic negative health consequences of excessive weight gain for both the obese mother and her child. Preventing excessive weight gain during pregnancy and postpartum weight retention is also important in the prevention of overweight and obesity among women of reproductive age. Obese women in general have a poor diet quality and are more exposed to psychosocial factors like anxiety and feelings of depression than normal weight women.
The aim of this project is to perform a randomized controlled trial (RCT) in order to evaluate the effects of life-style intervention (psycho-education by a midwife during 4 prenatal sessions) on pregnancy and birth outcomes. Main dependent variables are gestational weight gain and anxiety and depression. Obesity is a modifiable risk factor and optimizing an adequate gestational weight gain with attention to psycho-social factors, can reduce the need for adverse perinatal outcomes.
Conditions
- Obese Pregnant Women
Interventions
- BEHAVIORAL
-
Lifestyle counseling
4 prenatal sessions based on principles of motivational interviewing and positive reinforcement
- OTHER
-
brochure
brochure given after randomization
Sponsors & Collaborators
-
PHL University College
collaborator UNKNOWN -
Limburg Catholic University College
lead OTHER
Principal Investigators
-
Roland Devlieger, PhD, MD · Universitaire Ziekenhuizen KU Leuven
-
Bea Van den Bergh, PhD · University of Tilburg (Nl)
-
Ingrid Witters, PhD, MD · Universitaire Ziekenhuizen KU Leuven
-
Annick Bogaerts, MW, MSc, PhDstudent · KHLim PHL
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2011-04-30
- Completion
- 2013-12-31
Countries
- Belgium
Study Locations
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