Medical Nutrition Therapy Program for Pregnant Women With Diabetes

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.

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Gestational Diabetes
• Intervention / Treatment: Other: medical nutrition therapy program

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City
    • Mexico, Mexico City, Mexico, 11700
      • Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
metabolic control	every two weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
maternal nutritional status	every two weeks
fetal nutritional status	at labor
cost effectiveness	3 years

Collaborators and Investigators

• Sponsor: 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 Perinatologia Isidro Espinosa de los Reyes

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (ACTUAL): June 1, 2007
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: March 11, 2009
• First Submitted That Met QC Criteria: March 11, 2009
• First Posted (ESTIMATE): March 12, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 12, 2009
• Last Update Submitted That Met QC Criteria: March 11, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: nutritional status; metabolic control; gestational diabetes; glucose monitoring; cost effectiveness; medical nutrition therapy program
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 212250-02091