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Trial record 1 of 1460 for:    nutrition AND (woman OR women OR female)
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Medical Nutrition Therapy Program for Pregnant Women With Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00860613
First Posted: March 12, 2009
Last Update Posted: March 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
  Purpose
No dietary strategies have been designed and proved for Mexican pregnant women with diabetes. This is a randomized clinical trial of pregnant women with pregestational type 2 diabetes and gestational diabetes that were followed every two weeks until labor to assess the impact of the MNT program on metabolic control, maternal and fetal nutritional status and cost effectiveness. Participants were randomly assigned to one of three medical nutrition therapy (MNT) groups: the MNT 1 group (n=38) received usual medical treatment, counseling from a nutritionist and diabetes educator, using carbohydrate counting (40-45% of carbohydrates)with an intensive educational component; MNT2 group (n=50) had the same treatment, but included only low-moderate glycemic index foods; and NO-MNT group (n=45) received the current hospital treatment. All women will receive a glucose meter so they do self glucose monitoring (pre and postprandial) 2 times a weeks 6 times a day. Weight gain, dietary consumption and glucose concentrations will be evaluated every two weeks. Fetal outcomes (weight, length and presence of complications)will be measured at labor.

Condition Intervention
Gestational Diabetes Type 2 Diabetes Other: medical nutrition therapy program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Medical Nutrition Therapy Program for Pregnant Women With Diabetes: Evaluation of Two Different Dietary Strategies on Metabolic Control, Maternal and Fetal Nutritional Status and Cost Effectiveness.

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:

Primary Outcome Measures:
  • metabolic control [ Time Frame: every two weeks ]

Secondary Outcome Measures:
  • maternal nutritional status [ Time Frame: every two weeks ]
  • fetal nutritional status [ Time Frame: at labor ]
  • cost effectiveness [ Time Frame: 3 years ]

Enrollment: 162
Study Start Date: February 2004
Study Completion Date: December 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
women in this group received usual medical treatment and counseling from a nutritionist and diabetes educator. They received a specific diet using carbohydrate counting (40-45% of carbohydrates)and a moderate energy restriction. Weight gain, adequacy of diet, results of the self glucose monitoring, and ketonuria were evaluated every two weeks. They also received education on diabetes, diet and glucose monitoring.
Other: medical nutrition therapy program
the dietary guidelines were based on the Nutrition Practice guidelines for gestational diabetes developed by the American Dietetic Association. Dietary strategies were based on carbohydrate counting and/or restriction of high glycemic index foods. Even carbohydrate distribution throughout the day was emphasized.
Experimental: 2
Women in this group received usual medical treatment and counseling from a nutritionist and diabetes educator. The diet they received was based on carbohydrate counting (40-45% of carbohydrates), but recommended only low-moderate glycemic index foods. Weight gain, adequacy of diet, results of the self glucose monitoring, and ketonuria were evaluated every two weeks. They also received education on diabetes, diet and glucose monitoring.
Other: medical nutrition therapy program
the dietary guidelines were based on the Nutrition Practice guidelines for gestational diabetes developed by the American Dietetic Association. Dietary strategies were based on carbohydrate counting and/or restriction of high glycemic index foods. Even carbohydrate distribution throughout the day was emphasized.
No Intervention: 3
women in this group received the current hospital treatment. They did not receive any intervention except for the self glucose monitoring that they did every two weeks. Weight gain and the results of the self glucose monitoring, were evaluated every two weeks.

  Eligibility

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant women with gestational diabetes (Freinkle´s classification: type A2 and B1) or pregestational type 2 diabetes.
  • less than 30 weeks of gestation
  • women who plan to attend their pregnancy at the institution (INPerIER)

Exclusion Criteria:

  • women with type 1 pregestational diabetes or gestational diabetes type A1.
  • women with multiple pregnancies
  • women with renal or hepatic disease
  • women who could not follow the dietary recommendations within the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860613


Locations
Mexico
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Mexico, Mexico City, Mexico, 11700
Sponsors and Collaborators
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Investigators
Study Chair: Felipe Vadillo-Ortega, M.D, PhD Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Principal Investigator: Otilia Perichart-Perera, M.S, RD Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Study Chair: Margie Balas-Nakash, B.S Instituto Nacional de Perinatología Isidro Espionosa de los Reyes
Study Chair: Adalberto Parra-Covarrubias, M.D Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Study Chair: Ameyalli Rodriguez-Cano, B.S Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
  More Information

Responsible Party: Otilia Perichart Perera, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
ClinicalTrials.gov Identifier: NCT00860613     History of Changes
Other Study ID Numbers: 212250-02091
First Submitted: March 11, 2009
First Posted: March 12, 2009
Last Update Posted: March 12, 2009
Last Verified: March 2009

Keywords provided by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:
gestational diabetes
medical nutrition therapy program
glucose monitoring
metabolic control
nutritional status
cost effectiveness

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications