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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01329835
Enrollment
180
Registered
2011-04-06
Start date
2008-03-31
Completion date
2013-12-31
Last updated
2011-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese Pregnant Women

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.

Interventions

BEHAVIORALLifestyle counseling

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

OTHERbrochure

brochure given after randomization

Sponsors

PHL University College
CollaboratorUNKNOWN
Limburg Catholic University College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Less than 15 weeks pregnant

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Gestational weight gainFor the duration of pregnancy, an expected average of 40 weeksWeight just before delivery minus prepregnancy weight

Secondary

MeasureTime frameDescription
Evolutions in anxiety and depression during pregnancyDuring 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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026