- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03100383
Influence of Medical Nutrition Therapy and Eating Behavior on Gestational Weight Gain
Influence of Medical Nutrition Therapy and Eating Behavior on Gestational Weight Gain in Women With Diabetes
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women in puerperium with known T2DM or GDM diagnosed at the hospital.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating behavior
Time Frame: 9 months
|
The specific dimensions of eating behavior were measured through the 18-item Three-Factor Eating Questionnaire-18.
|
9 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 038/13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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