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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Limburg Catholic University College.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
PHL University College
Information provided by:
Limburg Catholic University College
ClinicalTrials.gov Identifier:
NCT01329835
First received: March 30, 2011
Last updated: December 5, 2011
Last verified: July 2008
  Purpose

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 Intervention
Obese Pregnant Women
Behavioral: Lifestyle counseling
Other: brochure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women

Resource links provided by NLM:


Further study details as provided by Limburg Catholic University College:

Primary Outcome Measures:
  • Gestational weight gain [ Time Frame: For the duration of pregnancy, an expected average of 40 weeks ] [ Designated as safety issue: Yes ]
    Weight just before delivery minus prepregnancy weight


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    STAI (Spielberger) ==> anxiety EPDS ==> depression


Estimated Enrollment: 180
Study Start Date: March 2008
Estimated Study Completion Date: December 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Less than 15 weeks pregnant

Exclusion Criteria:

  • Multiple pregnancy
  • Preexisting diabetes
  • Primary need for nutritional advice
  • Inadequate knowledge of Dutch language
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329835

Locations
Belgium
St-Jans Hospital ZOL Recruiting
Genk, Limburg, Belgium, 3600
Contact: Wilfried Gyselaers, PhD, MD       wilfried.gyselaers@zol.be   
Principal Investigator: Annick Bogaerts, PhD student         
Jessa Hospital Recruiting
Hasselt, Limburg, Belgium, 3500
Contact: Fancoise Jadoul, MD       francoise.jadoul@jessa.be   
SFZ Recruiting
Heusden, Limburg, Belgium, 3550
Contact: Luc Buekenhout, MD       luc.buekenhout@sfz.be   
Sponsors and Collaborators
Limburg Catholic University College
PHL University College
Investigators
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
  More Information

No publications provided

Responsible Party: Wim Jackmaer, PHL University College
ClinicalTrials.gov Identifier: NCT01329835     History of Changes
Other Study ID Numbers: GWG32011
Study First Received: March 30, 2011
Last Updated: December 5, 2011
Health Authority: Belgium: Medical Ethics Committee Katholieke Universiteit Leuven

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

ClinicalTrials.gov processed this record on November 27, 2014