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

Limburg Catholic University College

Status: Unknown

Conditions: Obese Pregnant Women

Treatments: Behavioral: Lifestyle counseling; Other: brochure

Study type: Interventional

Funder types: Other

Identifiers

NCT01329835

GWG32011

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Less than 15 weeks pregnant

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Written information via brochure

Experimental group

Description:

Written information by a brochure

Treatment:

Other: brochure

standard care

No Intervention group

Description:

standard prenatal care

Lifestyle counseling

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle counseling