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

NCT ID: NCT01329835

Last Updated: 2011-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obese Pregnant Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Written information via brochure

Written information by a brochure

Group Type EXPERIMENTAL

brochure

Intervention Type OTHER

brochure given after randomization

standard care

standard prenatal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Lifestyle counseling

Psycho-education based on principles of motivational interviewing and positive reinforcement

Group Type EXPERIMENTAL

Lifestyle counseling

Intervention Type BEHAVIORAL

4 prenatal sessions based on principles of motivational interviewing and positive reinforcement

Interventions

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Lifestyle counseling

4 prenatal sessions based on principles of motivational interviewing and positive reinforcement

Intervention Type BEHAVIORAL

brochure

brochure given after randomization

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Less than 15 weeks pregnant

Exclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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PHL University College

UNKNOWN

Sponsor Role collaborator

Limburg Catholic University College

OTHER

Sponsor Role lead

Responsible Party

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PHL University College

Principal Investigators

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Roland Devlieger, PhD, MD

Role: STUDY_DIRECTOR

Universitaire Ziekenhuizen KU Leuven

Bea Van den Bergh, PhD

Role: STUDY_DIRECTOR

University of Tilburg (Nl)

Ingrid Witters, PhD, MD

Role: STUDY_DIRECTOR

Universitaire Ziekenhuizen KU Leuven

Annick Bogaerts, MW, MSc, PhDstudent

Role: PRINCIPAL_INVESTIGATOR

KHLim PHL

Locations

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St-Jans Hospital ZOL

Genk, Limburg, Belgium

Site Status RECRUITING

Jessa Hospital

Hasselt, Limburg, Belgium

Site Status RECRUITING

SFZ

Heusden, Limburg, Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Wilfried Gyselaers, PhD, MD

Role: primary

Fancoise Jadoul, MD

Role: primary

Luc Buekenhout, MD

Role: primary

Other Identifiers

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GWG32011

Identifier Type: -

Identifier Source: org_study_id