Weight GainNCT03100383
Influence of Medical Nutrition Therapy and Eating Behavior on Gestational Weight Gain
An observational study of Weight Gain and Eating Behavior, run by Materno-Perinatal Hospital of the State of Mexico.
Trial summary
To assess the association of the number of medical nutrition therapy (MNT) consultations and eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) with GWG in women with type 2 diabetes mellitus (T2DM) and gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Weight Gain, Eating Behavior
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2013to 30 Nov 2014
- How long will I take part?
- 9 Months
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women in puerperium with known T2DM or GDM diagnosed at the hospital were invited to participate in the study.
Who may be able to join
- Women in puerperium with known T2DM or GDM diagnosed at the hospital.
Who cannot join
- Women with a twin or other multiple pregnancy, type 1 diabetes mellitus (T1DM), or intolerance to carbohydrates, and those with additional diseases (hypertensive disorders of pregnancy, hyper- or hypothyroidism, lupus, kidney or liver disease).
About this study
Official title: Influence of Medical Nutrition Therapy and Eating Behavior on Gestational Weight Gain in Women With Diabetes
To assess the association of the number of medical nutrition therapy (MNT) consultations and eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) with GWG in women with type 2 diabetes mellitus (T2DM) and gestational diabetes mellitus (GDM).
Read the detailed description
Women in puerperium with known T2DM or GDM diagnosed at the hospital were invited to participate in the study. Gestational diabetes was diagnosed with a 75-g oral glucose tolerance test. Weight (kg) and height (m) were measured using a mechanical column scale (SECA).
The specific dimensions of eating behavior were measured through the 18-item Three-Factor Eating Questionnaire-18 (TFEQ-18).
The Medical Nutrition Therapy (MNT) was offered every 2-4 weeks. This therapy consists of providing a food plan with the following recommendations: limiting carbohydrate intake to 35-45% of total calories calculated as 30 kcal/kg based on pregestational BMI for an ideal weight .
We evaluated the effect of MNT on GWG using a multiple linear regression model
- Conditions
- Weight Gain, Eating Behavior
- Keywords
- gestational diabetes, Type2 Diabetes
- Medical subject headings
- Weight Gain, Feeding Behavior, Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational Weight Gain (GWG).
GWG was calculated by subtracting the prepregnancy weight from the weight at the end of third trimester (kg).
Measured: 9 months
Secondary outcomes (1)
Eating behavior
The specific dimensions of eating behavior were measured through the 18-item Three-Factor Eating Questionnaire-18.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Nov 2013
- Primary completion1 Jun 2014
- Study completion30 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Materno-Perinatal Hospital of the State of Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico
- Investigators
- Hugo Mendieta Zerón, PhD., Principal investigator, Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100383
- Sponsor's protocol ID
- 038/13
- Status last verified
- Mar 2017
- First submitted
- 29 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Medical Nutrition Therapy and Eating Behavior on Gestational Weight Gain in Women With Diabetes
- ClinicalTrials.gov ID
- NCT03100383
- Acronym / sponsor ID
- 038/13
- Conditions
- Weight Gain, Eating Behavior
- Keywords
- gestational diabetes, Type2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Materno-Perinatal Hospital of the State of MexicoUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 30 Nov 2014 (actual)
- First posted
- 4 Apr 2017 (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.
To assess the association of the number of medical nutrition therapy (MNT) consultations and eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) with GWG in women with type 2 diabetes mellitus (T2DM) and gestational diabetes mellitus (GDM).
Detailed description
Women in puerperium with known T2DM or GDM diagnosed at the hospital were invited to participate in the study. Gestational diabetes was diagnosed with a 75-g oral glucose tolerance test. Weight (kg) and height (m) were measured using a mechanical column scale (SECA).
The specific dimensions of eating behavior were measured through the 18-item Three-Factor Eating Questionnaire-18 (TFEQ-18).
The Medical Nutrition Therapy (MNT) was offered every 2-4 weeks. This therapy consists of providing a food plan with the following recommendations: limiting carbohydrate intake to 35-45% of total calories calculated as 30 kcal/kg based on pregestational BMI for an ideal weight .
We evaluated the effect of MNT on GWG using a multiple linear regression model
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 9 Months
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women in puerperium with known T2DM or GDM diagnosed at the hospital were invited to participate in the study.
Key inclusion criteria (1 listed)
- Women in puerperium with known T2DM or GDM diagnosed at the hospital.
Key exclusion criteria (1 listed)
- Women with a twin or other multiple pregnancy, type 1 diabetes mellitus (T1DM), or intolerance to carbohydrates, and those with additional diseases (hypertensive disorders of pregnancy, hyper- or hypothyroidism, lupus, kidney or liver disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gestational Weight Gain (GWG).
Time frame: 9 months
GWG was calculated by subtracting the prepregnancy weight from the weight at the end of third trimester (kg).
1 secondary outcome
Eating behavior
Time frame: 9 months
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 4 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Hugo Mendieta Zerón, PhD. principal investigator
Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Gain and Eating Behavior, run by Materno-Perinatal Hospital of the State of 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 1 inclusion and 1 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 (GWG). (time frame: 9 months). 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 4 Apr 2017.