Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women

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.

Study Overview

• Status: Unknown
• Conditions: Obese Pregnant Women
• Intervention / Treatment: Other: brochure; Behavioral: Lifestyle counseling

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • St-Jans Hospital ZOL
      • Contact: Wilfried Gyselaers, PhD, MD; Email: wilfried.gyselaers@zol.be
      • Principal Investigator: Annick Bogaerts, PhD student
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Hospital
      • Contact: Fancoise Jadoul, MD; Email: francoise.jadoul@jessa.be
    • Heusden, Limburg, Belgium, 3550
      • Recruiting
      • SFZ
      • Contact: Luc Buekenhout, MD; Email: luc.buekenhout@sfz.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Less than 15 weeks pregnant

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Written information via brochure; Written information by a brochure	Other: brochure; brochure given after randomization
No Intervention: standard care; standard prenatal care
Experimental: Lifestyle counseling; Psycho-education based on principles of motivational interviewing and positive reinforcement	Behavioral: Lifestyle counseling; 4 prenatal sessions based on principles of motivational interviewing and positive reinforcement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational weight gain	Weight just before delivery minus prepregnancy weight	For the duration of pregnancy, an expected average of 40 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolutions in anxiety and depression during pregnancy	STAI (Spielberger) ==> anxiety EPDS ==> depression	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)

Collaborators and Investigators

• Sponsor: Limburg Catholic University College
• Collaborators: PHL University College
• Investigators: Study Director: Roland Devlieger, PhD, MD, Universitaire Ziekenhuizen KU Leuven; Study Director: Bea Van den Bergh, PhD, University of Tilburg (Nl); Study Director: Ingrid Witters, PhD, MD, Universitaire Ziekenhuizen KU Leuven; Principal Investigator: Annick Bogaerts, MW, MSc, PhDstudent, KHLim PHL

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: April 4, 2011
• First Posted (Estimate): April 6, 2011

Study Record Updates

• Last Update Posted (Estimate): December 6, 2011
• Last Update Submitted That Met QC Criteria: December 5, 2011
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: GWG32011