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

NCT01329835 | Unknown

• 1 other identifier: GWG32011
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

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.

Conditions

Obese Pregnant Women

Outcome Measures

Primary Outcomes (1)

• Gestational weight gain

  Weight just before delivery minus prepregnancy weight

  For the duration of pregnancy, an expected average of 40 weeks

Secondary Outcomes (1)

• Evolutions in anxiety and depression during pregnancy

  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)

Study Arms (3)

Written information via brochure

EXPERIMENTAL

Written information by a brochure

Other: brochure

standard care

NO INTERVENTION

standard prenatal care

Lifestyle counseling

EXPERIMENTAL

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

Behavioral: Lifestyle counseling

Interventions

Lifestyle counseling BEHAVIORAL

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

Lifestyle counseling

brochure OTHER

brochure given after randomization

Written information via brochure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Less than 15 weeks pregnant

You may not qualify if:

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

Sponsors & Collaborators

• Limburg Catholic University College: lead
• PHL University College: collaborator

Study Sites (3)

St-Jans Hospital ZOL

Genk, Limburg, 3600, Belgium

RECRUITING

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

SFZ

Heusden, Limburg, 3550, Belgium

RECRUITING

Study Officials

• 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

  STUDY DIRECTOR

• Annick Bogaerts, MW, MSc, PhDstudent

  KHLim PHL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 6, 2011
• Study Start: March 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2013
• Last Updated: December 6, 2011

Record last verified: 2008-07

Locations

BE (3)