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

Obese Pregnant Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01329835
• Other study ID #: GWG32011
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2011
• Last updated: December 5, 2011
• Start date: March 2008
• Est. completion date: December 2013

Study information

• Verified date: July 2008
• Source: Limburg Catholic University College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Medical Ethics Committee Katholieke Universiteit Leuven
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obese Pregnant Women
• Weight Gain

Intervention

Behavioral:
• Lifestyle counseling
4 prenatal sessions based on principles of motivational interviewing and positive reinforcement

Other:
• brochure
brochure given after randomization

Locations

Country	Name	City	State
Belgium	St-Jans Hospital ZOL	Genk	Limburg
Belgium	Jessa Hospital	Hasselt	Limburg
Belgium	SFZ	Heusden	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Limburg Catholic University College	PHL University College

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational weight gain	Weight just before delivery minus prepregnancy weight	For the duration of pregnancy, an expected average of 40 weeks	Yes
Secondary	Evolutions in anxiety and depression during pregnancy	STAI (Spielberger) ==> anxiety EPDS ==> depression	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)	Yes