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

Study Overview
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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.

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

Conditions
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Obese Pregnant Women

Intervention / Treatment
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* Behavioral: Lifestyle counseling
* Other: brochure


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Written information via brochure<br>Written information by a brochure | Other: brochure<br>* brochure given after randomization<br>|
| No Intervention: standard care<br>standard prenatal care | |
| Experimental: Lifestyle counseling<br>Psycho-education based on principles of motivational interviewing and positive reinforcement | Behavioral: Lifestyle counseling<br>* 4 prenatal sessions based on principles of motivational interviewing and positive reinforcement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain | Weight just before delivery minus prepregnancy weight | For the duration of pregnancy, an expected average of 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |