The PREDG study: testing whether an educational intervention can prevent excess weight gain during pregnancy
| ISRCTN | ISRCTN61793947 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61793947 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | FIBHULP PI-1980 |
| Sponsor | Fundación Investigación Biomédica Hospital Universitario La Paz (FIBHULP) |
| Funder | Foundation for Biomedical Research of La Paz University Hospital |
- Submission date
- 29/11/2018
- Registration date
- 10/12/2018
- Last edited
- 20/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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?
November 2018 to June 2022
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
Contact information
Scientific
Ps. Castellana 261
Madrid
28046
Spain
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, randomized controlled trial, single-centre, single blind |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The PREDG study: a randomised controlled trial testing whether an educational intervention can prevent gestational weight gain in obese women |
| Study acronym | PREDG |
| Study objectives | 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(s) | Comité Ético HULP, 06/09/2018, ref. FIBHULP PI-1980. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Gestational weight gain will be measured using weight (kg) in each monthly visit minus weight before pregnancy. |
| Key secondary outcome measure(s) |
1. Pregnancy complications: |
| Completion date | 17/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 190 |
| Total final enrolment | 210 |
| Key inclusion criteria | 1. BMI ≥ 30 kg/m2 prior to becoming pregnant |
| Key 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 |
| Date of first enrolment | 02/01/2019 |
| Date of final enrolment | 07/09/2021 |
Locations
Countries of recruitment
- Spain
Study participating centre
Madrid
28046
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The available data collected will be available on request for statistical analyses from Dr Beatriz Barquiel (beatriz.barquiel@gmail.com). All participants gave their written informed consent. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/07/2023 | 20/07/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/07/2023: Publication reference added.
29/06/2022: Contact details updated.
28/06/2022: The overall trial end date was changed from 30/06/2022 to 17/06/2022.
15/09/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2021 to 07/09/2021.
2. The total final enrolment was added.
01/12/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 29/12/2020 to 30/09/2021.
2. The overall trial end date was changed from 30/09/2021 to 30/06/2022.
3. The intention to publish date was changed from 30/03/2022 to 30/12/2022.
05/11/2020: The recruitment resumed on 01/10/2020.
04/11/2020: The following changes were made to the trial record:
1. The overall end date was changed from 29/11/2020 to 30/09/2021.
2. The intention to publish date was changed from 01/03/2021 to 30/03/2022.
3. The plain English summary was updated to reflect these changes.
15/04/2020: Due to current public health guidance, recruitment for this study has been paused.
