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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01329835 on ClinicalTrials.gov