Obese Pregnant WomenNCT01329835
Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women
A study testing Lifestyle counseling and brochure in people with Obese Pregnant Women, run by Limburg Catholic University College at 3 sites in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obese Pregnant Women
- What is being tested?
- Lifestyle counseling and brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesBelgium
- Study dates
- Mar 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Less than 15 weeks pregnant
Who cannot join
- Multiple pregnancy
- Preexisting diabetes
- Primary need for nutritional advice
- Inadequate knowledge of Dutch language
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites, 3 recruiting
- Recruiting
St-Jans Hospital ZOL
Genk, Limburg, 3600
Wilfried Gyselaers, PhD, MD, wilfried.gyselaers@zol.be
Annick Bogaerts, PhD student
- Recruiting
Jessa Hospital
Hasselt, Limburg, 3500
Fancoise Jadoul, MD, francoise.jadoul@jessa.be
- Recruiting
SFZ
Heusden, Limburg, 3550
Luc Buekenhout, MD, luc.buekenhout@sfz.be
About this study
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.
- Conditions
- Obese Pregnant Women
- Being tested
- Lifestyle counseling, brochure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
4 prenatal sessions based on principles of motivational interviewing and positive reinforcement
brochureOther
brochure given after randomization
| Study group | Role | What they receive |
|---|---|---|
| Written information via brochure | Experimental | Written information by a brochure Receives: Other: brochure |
| standard care | No intervention | standard prenatal care |
| Lifestyle counseling | Experimental | Psycho-education based on principles of motivational interviewing and positive reinforcement Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain
Weight just before delivery minus prepregnancy weight
Measured: For the duration of pregnancy, an expected average of 40 weeks
Secondary outcomes (1)
Evolutions in anxiety and depression during pregnancy
STAI (Spielberger) ==> anxiety EPDS ==> depression
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMar 2008
- Primary completionApr 2011
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limburg Catholic University College
- Sponsor type
- University, hospital or other
- Collaborators
- PHL University College
- Investigators
- Roland Devlieger, PhD, MD, Study director, Universitaire Ziekenhuizen KU LeuvenBea Van den Bergh, PhD, Study director, University of Tilburg (Nl)Ingrid Witters, PhD, MD, Study director, Universitaire Ziekenhuizen KU LeuvenAnnick Bogaerts, MW, MSc, PhDstudent, Principal investigator, KHLim PHL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329835
- Sponsor's protocol ID
- GWG32011
- Status last verified
- Jul 2008
- First submitted
- 30 Mar 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Psycho-education on Gestational Weight Gain and Anxiety/Depression in Obese Pregnant Women
- ClinicalTrials.gov ID
- NCT01329835
- Acronym / sponsor ID
- GWG32011
- Conditions
- Obese Pregnant Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Limburg Catholic University CollegeUniversity, hospital or other
- Collaborators
- PHL University College
- Study start
- Mar 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 6 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Written information via brochure | Experimental | Other: brochureWritten information by a brochure |
| standard care | No intervention | –standard prenatal care |
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counselingPsycho-education based on principles of motivational interviewing and positive reinforcement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Less than 15 weeks pregnant
Key exclusion criteria (4 listed)
- Multiple pregnancy
- Preexisting diabetes
- Primary need for nutritional advice
- Inadequate knowledge of Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle counseling4 prenatal sessions based on principles of motivational interviewing and positive reinforcement | Behavioural | Lifestyle counseling |
| brochurebrochure given after randomization | Other | Written information via brochure |
Primary outcome
Gestational weight gain
Time frame: For the duration of pregnancy, an expected average of 40 weeks
Weight just before delivery minus prepregnancy weight
1 secondary outcome
Evolutions in anxiety and depression during pregnancy
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Devlieger, PhD, MD study director
Universitaire Ziekenhuizen KU Leuven
Bea Van den Bergh, PhD study director
University of Tilburg (Nl)
Ingrid Witters, PhD, MD study director
Universitaire Ziekenhuizen KU Leuven
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling and brochure in people with Obese Pregnant Women, run by Limburg Catholic University College at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational weight gain (time frame: For the duration of pregnancy, an expected average of 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2011.