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

Not Applicable

• Conditions: Obese Pregnant Women
• Interventions: Other: brochure; Behavioral: Lifestyle counseling

• Registration Number: NCT01329835
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Status Verified: 2008-07
• Study First Submitted: 2011-03-30
• Primary Completion: 2011-04
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-06
• Last Update Submitted: 2011-12-05
• Last Update Posted: 2011-12-06
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• Less than 15 weeks pregnant

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Written information via brochure	brochure	Written information by a brochure
Lifestyle counseling	Lifestyle counseling	Psycho-education based on principles of motivational interviewing and positive reinforcement

Primary Outcome Measures

Name	Time	Method
Gestational weight gain	For the duration of pregnancy, an expected average of 40 weeks	Weight just before delivery minus prepregnancy weight

Secondary Outcome Measures

Name	Time	Method
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)	STAI (Spielberger) ==\> anxiety EPDS ==\> depression

Trial Locations

Locations (3)

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium

St-Jans Hospital ZOL; 🇧🇪 Genk, Limburg, Belgium

SFZ; 🇧🇪 Heusden, Limburg, Belgium