Trial record 60 of 2347 for:    depression AND (woman OR women OR female)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01329835
Recruitment Status : Unknown
Verified July 2008 by Limburg Catholic University College.
Recruitment status was:  Recruiting
First Posted : April 6, 2011
Last Update Posted : December 6, 2011
PHL University College
Information provided by:
Limburg Catholic University College

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.

Condition or disease Intervention/treatment Phase
Obese Pregnant Women Behavioral: Lifestyle counseling Other: brochure Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women
Study Start Date : March 2008
Actual Primary Completion Date : April 2011
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Body Weight

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

Primary Outcome Measures :
  1. Gestational weight gain [ Time Frame: For the duration of pregnancy, an expected average of 40 weeks ]
    Weight just before delivery minus prepregnancy weight

Secondary Outcome Measures :
  1. Evolutions in anxiety and depression during pregnancy [ Time Frame: 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) ]
    STAI (Spielberger) ==> anxiety EPDS ==> depression

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Less than 15 weeks pregnant

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01329835

St-Jans Hospital ZOL Recruiting
Genk, Limburg, Belgium, 3600
Contact: Wilfried Gyselaers, PhD, MD   
Principal Investigator: Annick Bogaerts, PhD student         
Jessa Hospital Recruiting
Hasselt, Limburg, Belgium, 3500
Contact: Fancoise Jadoul, MD   
SFZ Recruiting
Heusden, Limburg, Belgium, 3550
Contact: Luc Buekenhout, MD   
Sponsors and Collaborators
Limburg Catholic University College
PHL University College
Study Director: Roland Devlieger, PhD, MD University Hospitals Leuven
Study Director: Bea Van den Bergh, PhD University of Tilburg (Nl)
Study Director: Ingrid Witters, PhD, MD University Hospitals Leuven
Principal Investigator: Annick Bogaerts, MW, MSc, PhDstudent KHLim PHL

Responsible Party: Wim Jackmaer, PHL University College Identifier: NCT01329835     History of Changes
Other Study ID Numbers: GWG32011
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: December 6, 2011
Last Verified: July 2008

Additional relevant MeSH terms:
Weight Gain
Behavioral Symptoms
Body Weight Changes
Body Weight
Signs and Symptoms