Clinical trial NCT01329835: Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women
Official title: Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obese Pregnant Women
Lead sponsor: Limburg Catholic University College
Sponsor class: OTHER
Collaborators: name: PHL University College
First posted: 2011-04-06
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Less than 15 weeks pregnant

Exclusion Criteria:

* Multiple pregnancy
* Preexisting diabetes
* Primary need for nutritional advice
* Inadequate knowledge of Dutch language

Primary outcomes:
measure: Gestational weight gain
timeFrame: For the duration of pregnancy, an expected average of 40 weeks
Secondary outcomes:
measure: Evolutions in anxiety and depression during pregnancy
timeFrame: During pregnancy on fixed time points: trimester 1 (before 15 weeks of gestation), trimester 2 (between 18 and 28 weeks of gestation) and trimester 3 (between 30 - 34 weeks of gestation)
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: St-Jans Hospital ZOL
state: Limburg
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
city: Heusden
country: Belgium
facility: SFZ
state: Limburg
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Roland Devlieger, PhD, MD
role: STUDY_DIRECTOR
affiliation: University of Tilburg (Nl)
name: Bea Van den Bergh, PhD
role: STUDY_DIRECTOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Ingrid Witters, PhD, MD
role: STUDY_DIRECTOR
affiliation: KHLim PHL
name: Annick Bogaerts, MW, MSc, PhDstudent
role: PRINCIPAL_INVESTIGATOR
References: