Medical Nutrition Therapy Program for Pregnant Women With Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Gestational Diabetes, Type 2 Diabetes

Intervention / Treatment
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* Other: medical nutrition therapy program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 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.<br>|
| Experimental: 2<br>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<br>* 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.<br>|
| No Intervention: 3<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic control |  | every two weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes, medical nutrition therapy program, glucose monitoring, metabolic control, nutritional status, cost effectiveness