NCT00860613

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gestational Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-02-01
• Primary completion: 2007-06-01
• Completion: 2008-12-01
• First posted: 2009-03-12
• Last updated: 2009-03-12

Locations

1 site across 1 country: Mexico