Gestational Weight GainNCT03767699
Medical Nutrition Therapy Program and Eating Behavior Questionnaires on Gestational Weight Gain
An observational study of Gestational Weight Gain, run by Hugo Mendieta Zeron at 1 site in Mexico.
Trial summary
Type 2 Diabetes Mellitus (T2DM) and Gestational Diabetes Mellitus (GDM) create complications during pregnancy, particularly in women with gestational weight gain (GWG) that falls over the recommended limit. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Weight Gain
- What is being tested?
- Medical Nutrition Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 57 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2013to Nov 2014
- Phase
- Observational
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with T2DM or GDM who received as a routine management the Medical Nutrition Therapy. The characteristics of the pregnant women usually attended at the Maternal-Perinatal Hospital "Mónica Pretelini Sáenz" are: low socioecomic status and education, they all receive free medical attention.
Who may be able to join
- Women who had given birth and with known T2DM.
- Women who had given birth and with GDM diagnosed during pregnancy.
Who cannot join
- Women with multiple pregnancies.
- Women with type 1 diabetes mellitus.
- Women with glucose intolerance.
- Women with chronic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical Nutrition Therapy Program and Eating Behavior Questionnaires on Gestational Weight Gain in Mexican Women With Diabetes
Type 2 Diabetes Mellitus (T2DM) and Gestational Diabetes Mellitus (GDM) create complications during pregnancy, particularly in women with gestational weight gain (GWG) that falls over the recommended limit. On the other hand Medical nutrition therapy (MNT) has been shown to reduce some complications in women with T2DM and GDM. The aim of this project was to assess the association of MNT consultations and eating behavior with GWG in Mexican women with T2DM and GDM.
Read the detailed description
This cross-sectional study conducted at from 2013 to 2014. Fifty seven patients with T2DM or GDM were invited to participate. The dependent variable was GWG and the main independent variables were MNT and eating behaviors. Data were obtained from medical records or interviews. Multiple linear regression models were used to assess associations.
- Conditions
- Gestational Weight Gain
- Being tested
- Medical Nutrition Therapy
- Keywords
- Medical nutrition therapy, Eating behavior, Type 2 diabetes mellitus, Gestational Diabetes
- Medical subject headings
- Gestational Weight Gain, Feeding Behavior, Diabetes Mellitus, Type 2, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Nutrition TherapyBehavioural
MNT was offered every 2-4 weeks to all pregnant women with T2DM and GDM. Women. MNT is offered as a mandatory part of their prenatal visit and/or hospital stay. The MNT provides an individual food plan with the following recommendations: total calories should be calculated as 30 kcal/kg based on pregestational BMI for an ideal weight. Of the total energy intake 40-45% is provided by carbohydrates, a maximum of 40% is provided by lipids and the remaining percentage by proteins providing moderate-to-low glycemic index foods and fiber consumption, glucose self-monitoring, participating in 15-30 min of daily physical activity after prior authorization of the treating physician, and meeting the minimal energy requirements of pregnancy (never < 1,500 kcal).
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Weight Gain
Weight (kg) was measured using a weight scale (SECA 711). GWG was calculated by subtracting the prepregnancy weight from the weight at the end of the third trimester (kg). Recommended GWG was based on U.S. Institute of Medicine guidelines.
Measured: Nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study startNov 2013
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational Weight GainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo Mendieta Zeron
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Instituto Nacional de Salud Publica, Mexico
- Responsible party
- Sponsor-investigator, Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico
- Investigators
- Adriana Garduño Alanís, PhD., Study chair, Independent researcher.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767699
- Sponsor's protocol ID
- 2013-12-239
- Other IDs
- D43TW009135
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Information will be available upon request.
Publications
Horosz E, Bomba-Opon DA, Szymanska M, Wielgos M. Maternal weight gain in women with gestational diabetes mellitus. J Perinat Med. 2013 Sep 1;41(5):523-8. doi: 10.1515/jpm-2012-0254.
PubMed 23492551Perichart-Perera O, Balas-Nakash M, Parra-Covarrubias A, Rodriguez-Cano A, Ramirez-Torres A, Ortega-Gonzalez C, Vadillo-Ortega F. A medical nutrition therapy program improves perinatal outcomes in Mexican pregnant women with gestational diabetes and type 2 diabetes mellitus. Diabetes Educ. 2009 Nov-Dec;35(6):1004-13. doi: 10.1177/0145721709343125. Epub 2009 Aug 20.
PubMed 19696205Balas-Nakash M, Rodriguez-Cano A, Munoz-Manrique C, Vasquez-Pena P, Perichart-Perera O. [Adherence to a medical nutrition therapy program in pregnant women with diabetes, measured by three methods, and its association with glycemic control]. Rev Invest Clin. 2010 May-Jun;62(3):235-43. Spanish.
PubMed 20815129Jaakkola J, Hakala P, Isolauri E, Poussa T, Laitinen K. Eating behavior influences diet, weight, and central obesity in women after pregnancy. Nutrition. 2013 Oct;29(10):1209-13. doi: 10.1016/j.nut.2013.03.008. Epub 2013 Jun 22.
PubMed 23800568Garduno-Alanis A, Torres-Mejia G, Nava-Diaz P, Herrera-Villalobos J, Diaz-Arizmendi D, Mendieta-Zeron H. Association between a medical nutrition therapy program and eating behavior with gestational weight gain in women with diabetes. J Matern Fetal Neonatal Med. 2020 Dec;33(24):4049-4054. doi: 10.1080/14767058.2019.1594764. Epub 2019 Mar 28.
PubMed 30880554
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Nutrition Therapy Program and Eating Behavior Questionnaires on Gestational Weight Gain in Mexican Women With Diabetes
- ClinicalTrials.gov ID
- NCT03767699
- Acronym / sponsor ID
- 2013-12-239
- Conditions
- Gestational Weight Gain
- Keywords
- Medical nutrition therapy, Eating behavior, Type 2 diabetes mellitus, Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hugo Mendieta ZeronUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Instituto Nacional de Salud Publica, Mexico
- Study start
- Nov 2013 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Dec 2018 (actual)
- 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.
Type 2 Diabetes Mellitus (T2DM) and Gestational Diabetes Mellitus (GDM) create complications during pregnancy, particularly in women with gestational weight gain (GWG) that falls over the recommended limit. On the other hand Medical nutrition therapy (MNT) has been shown to reduce some complications in women with T2DM and GDM. The aim of this project was to assess the association of MNT consultations and eating behavior with GWG in Mexican women with T2DM and GDM.
Detailed description
This cross-sectional study conducted at from 2013 to 2014. Fifty seven patients with T2DM or GDM were invited to participate. The dependent variable was GWG and the main independent variables were MNT and eating behaviors. Data were obtained from medical records or interviews. Multiple linear regression models were used to assess associations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with T2DM or GDM who received as a routine management the Medical Nutrition Therapy. The characteristics of the pregnant women usually attended at the Maternal-Perinatal Hospital "Mónica Pretelini Sáenz" are: low socioecomic status and education, they all receive free medical attention.
Key inclusion criteria (2 listed)
- Women who had given birth and with known T2DM.
- Women who had given birth and with GDM diagnosed during pregnancy.
Key exclusion criteria (4 listed)
- Women with multiple pregnancies.
- Women with type 1 diabetes mellitus.
- Women with glucose intolerance.
- Women with chronic diseases.
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 |
|---|---|---|
| Medical Nutrition TherapyMNT was offered every 2-4 weeks to all pregnant women with T2DM and GDM. Women. MNT is offered as a mandatory part of their prenatal visit and/or hospital stay. The MNT provides an individual food plan with the following recommendations: total calories should be calculated as 30 kcal/kg based on pregestational BMI for an ideal weight. Of the total energy intake 40-45% is provided by carbohydrates, a maximum of 40% is provided by lipids and the remaining percentage by proteins providing moderate-to-low glycemic index foods and fiber consumption, glucose self-monitoring, participating in 15-30 min of daily physical activity after prior authorization of the treating physician, and meeting the minimal energy requirements of pregnancy (never < 1,500 kcal). | Behavioural | – |
Primary outcome
Gestational Weight Gain
Time frame: Nine months
Weight (kg) was measured using a weight scale (SECA 711). GWG was calculated by subtracting the prepregnancy weight from the weight at the end of the third trimester (kg). Recommended GWG was based on U.S. Institute of Medicine guidelines.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Background: PubMed 23492551Horosz E, Bomba-Opon DA, Szymanska M, Wielgos M. Maternal weight gain in women with gestational diabetes mellitus. J Perinat Med. 2013 Sep 1;41(5):523-8. doi: 10.1515/jpm-2012-0254.
- Background: PubMed 19696205Perichart-Perera O, Balas-Nakash M, Parra-Covarrubias A, Rodriguez-Cano A, Ramirez-Torres A, Ortega-Gonzalez C, Vadillo-Ortega F. A medical nutrition therapy program improves perinatal outcomes in Mexican pregnant women with gestational diabetes and type 2 diabetes mellitus. Diabetes Educ. 2009 Nov-Dec;35(6):1004-13. doi: 10.1177/0145721709343125. Epub 2009 Aug 20.
- Background: PubMed 20815129Balas-Nakash M, Rodriguez-Cano A, Munoz-Manrique C, Vasquez-Pena P, Perichart-Perera O. [Adherence to a medical nutrition therapy program in pregnant women with diabetes, measured by three methods, and its association with glycemic control]. Rev Invest Clin. 2010 May-Jun;62(3):235-43. Spanish.
- Background: PubMed 23800568Jaakkola J, Hakala P, Isolauri E, Poussa T, Laitinen K. Eating behavior influences diet, weight, and central obesity in women after pregnancy. Nutrition. 2013 Oct;29(10):1209-13. doi: 10.1016/j.nut.2013.03.008. Epub 2013 Jun 22.
- Derived from this study: PubMed 30880554Garduno-Alanis A, Torres-Mejia G, Nava-Diaz P, Herrera-Villalobos J, Diaz-Arizmendi D, Mendieta-Zeron H. Association between a medical nutrition therapy program and eating behavior with gestational weight gain in women with diabetes. J Matern Fetal Neonatal Med. 2020 Dec;33(24):4049-4054. doi: 10.1080/14767058.2019.1594764. Epub 2019 Mar 28.
- Individual participant dataSharing planned: Undecided. Information will be available upon request.
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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.
Adriana Garduño Alanís, PhD. study chair
Independent researcher.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Weight Gain, run by Hugo Mendieta Zeron at 1 site in Mexico.
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 2 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: finished, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Weight Gain (time frame: Nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767699, which also lists 5 linked publications.
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 7 Dec 2018.