Condition category
Pregnancy and Childbirth
Date applied
29/11/2018
Date assigned
10/12/2018
Last edited
10/12/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims:
The objective of the present project is to validate the effect of an educational intervention to prevent an excess of gestational weight gain in women with obesity. Excessive gestational weight gain is associated with gestational hypertension, preeclampsian, cesarean section and large birth weight. After pregnancy, gestational weight gain is the main cause of postpartum obesity.

Who can participate?
Women with obesity previous to pregnancy can participate in the study

What does the study involve?
The study involves education on diet and physical activity, information about an adequate gestational weight gain and biochemical and physical specific measurements.

What are the possible benefits and risks of participating?
The possible benefits of the study are obtaining an adequate gestational weight gain and, consequently, reducing pregnancy complications such as hypertension or diabetes.

Whre is the study run from?
Hospital Universitario La Paz, Madrid

When is the study starting and how long is it expected to run for?
The study is starting on 2/1/2019 and will be finished on 29/12/2020

Who is funding the study?
Fundación Investigación Biomédica Hospital Universitario La Paz (FIBHULP)

Who is the main contact?
Dr Beatriz Barquiel
beatriz.barquiel@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Beatriz Barquiel

ORCID ID

Contact details

Pza Conde Valle Suchil 9
7ºC
Madrid
28015
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FIBHULP PI-1980

Study information

Scientific title

The PREDG study: a randomised controlled trial testing whether an educational intervention can prevent gestational weight gain in obese women

Acronym

PREDG

Study hypothesis

An intervention consisting of dietetic education, physical activity and information of women with obesity may be useful to prevent excess gestational weight gain. Consequently, pregnancy complications and pospartum weight retention may be reduced.

Ethics approval

Comité Ético HULP, 06/09/2018, ref. FIBHULP PI-1980.

Study design

Interventional, randomised controlled trial, single-centre, single blind

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Gestational weight gain in obese women

Intervention

The randomisation will be automatically generated by a informatic program that assigns an random number to consecutive patients. The intervention arm will have an educational session about an adequate diet and physical activity. Diet will be calculated for the initial BMI, physical activity and pregnancy specific necessities. Both arms will receive information about an adequate gestational weight gain. Both arms will have biochemical determinations: basic, lipid profile, thyroid hormones, body impedance and weight and waist measurement. Follow up will continue for 6 months after delivery.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Gestational weight gain will be measured using weight (kg) in each monthly visit minus weight before pregnancy.

Secondary outcome measures

1. Pregnancy complications:
1.1. Gestational hypertension as arterial pressure >= 140 and/or 90 mmHg confirmed twice
1.2. Gestational diabetes as defined by NDDG criteria
1.3. Preterm birth as birth before 37 weeks of pregnancy
1.4. Cesarean section as rate of cesarean section
1.5. Macrosomia as neonatal birthweight >= 4 kg
1.6. Small as neonatal birthweight < 10th percentile for gestational age and sex
2. Postpartum weight retention as weight 6 months postpartum minus prepregnancy weight (kg).

Overall trial start date

29/11/2018

Overall trial end date

29/11/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. BMI ≥ 30 kg/m2 prior to becoming pregnant

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

190

Participant exclusion criteria

1. Treatment with an effect on body weight (fluoxetina, orlistat, metformina, GLP-1 agonists, pioglitazone)
2. Illness with organic deterioration (HIV disease, kidney or hepatic advanced insufficiency, cancer)
3. Invalidating mental disease
4. Participants of other study
5. Other criteria considered by the investigator

Recruitment start date

02/01/2019

Recruitment end date

29/12/2020

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Universitario La Paz
Ps Castellana 261
Madrid
28046
Spain

Sponsor information

Organisation

Fundación Investigación Biomédica Hospital Universitario La Paz (FIBHULP)

Sponsor details

Ps Castellana 261
Madrid
28046
Spain

Sponsor type

Hospital/treatment centre

Website

idipaz.es

Funders

Funder type

Research organisation

Funder name

Foundation for Biomedical Research of La Paz University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results on primary and secondary outcomes of the trial will be presented at national and international conferences and published in Endocrinology journals with an impact factor.

IPD sharing statement: the available data collected will be available on request for statistical analyses from Dr Beatriz Barquiel (beatriz.barquiel@gmail.com).

Intention to publish date

01/03/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes