Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women
Primary Purpose
Obese Pregnant Women
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Lifestyle counseling
brochure
Sponsored by
About this trial
This is an interventional prevention trial for Obese Pregnant Women
Eligibility Criteria
Inclusion Criteria:
- Less than 15 weeks pregnant
Exclusion Criteria:
- Multiple pregnancy
- Preexisting diabetes
- Primary need for nutritional advice
- Inadequate knowledge of Dutch language
Sites / Locations
- St-Jans Hospital ZOLRecruiting
- Jessa HospitalRecruiting
- SFZRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Experimental
Arm Label
Written information via brochure
standard care
Lifestyle counseling
Arm Description
Written information by a brochure
standard prenatal care
Psycho-education based on principles of motivational interviewing and positive reinforcement
Outcomes
Primary Outcome Measures
Gestational weight gain
Weight just before delivery minus prepregnancy weight
Secondary Outcome Measures
Evolutions in anxiety and depression during pregnancy
STAI (Spielberger) ==> anxiety EPDS ==> depression
Full Information
NCT ID
NCT01329835
First Posted
March 30, 2011
Last Updated
December 5, 2011
Sponsor
Limburg Catholic University College
Collaborators
PHL University College
1. Study Identification
Unique Protocol Identification Number
NCT01329835
Brief Title
Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women
Official Title
Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Limburg Catholic University College
Collaborators
PHL University College
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese Pregnant Women
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Written information via brochure
Arm Type
Experimental
Arm Description
Written information by a brochure
Arm Title
standard care
Arm Type
No Intervention
Arm Description
standard prenatal care
Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Psycho-education based on principles of motivational interviewing and positive reinforcement
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
4 prenatal sessions based on principles of motivational interviewing and positive reinforcement
Intervention Type
Other
Intervention Name(s)
brochure
Intervention Description
brochure given after randomization
Primary Outcome Measure Information:
Title
Gestational weight gain
Description
Weight just before delivery minus prepregnancy weight
Time Frame
For the duration of pregnancy, an expected average of 40 weeks
Secondary Outcome Measure Information:
Title
Evolutions in anxiety and depression during pregnancy
Description
STAI (Spielberger) ==> anxiety EPDS ==> depression
Time Frame
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Less than 15 weeks pregnant
Exclusion Criteria:
Multiple pregnancy
Preexisting diabetes
Primary need for nutritional advice
Inadequate knowledge of Dutch language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Devlieger, PhD, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bea Van den Bergh, PhD
Organizational Affiliation
University of Tilburg (Nl)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ingrid Witters, PhD, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Annick Bogaerts, MW, MSc, PhDstudent
Organizational Affiliation
KHLim PHL
Official's Role
Principal Investigator
Facility Information:
Facility Name
St-Jans Hospital ZOL
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilfried Gyselaers, PhD, MD
Email
wilfried.gyselaers@zol.be
First Name & Middle Initial & Last Name & Degree
Annick Bogaerts, PhD student
Facility Name
Jessa Hospital
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fancoise Jadoul, MD
Email
francoise.jadoul@jessa.be
Facility Name
SFZ
City
Heusden
State/Province
Limburg
ZIP/Postal Code
3550
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Buekenhout, MD
Email
luc.buekenhout@sfz.be
12. IPD Sharing Statement
Learn more about this trial
Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women
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