Impact of a Nutritional Intervention Program for Weight Control During Pregnancy

Study Overview
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Brief Summary
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This is a randomized clinical trial for evaluate the impact of a nutritional intervention in the weight control of pregnant women according to the nutritional status, and consequently, the reduction of pregnancy complications. The sample of this study will be composed by 318 pregnant women in the pre-natal care unit of the Health Center in Viamão city / Rio Grande do Sul, including women between the 10th and 25th weeks of gestation, aged up to 35 years old. The eligible pregnant women will be invited by the fieldworks to participated in the trial after be informed about the overall aims of the study. These women willing to participate will be randomly allocated to either the intervention or control group. The intervention group received specific guidelines about feeding practices appropriate to each nutritional status. Data on pregnant women will be collected through a questionnaire in both groups, and to assess the food intake, three 24-hour food recall will be applied in the interventional group and two recall in the control group, in initial and final gestational period. In all appointments pregnant women of the two groups will be weight and classified according to Body Mass Index of pre-gestational (BMI). The dietary advices will be elaborated by the author of the project and nutrition graduation students of Federal University of Health Science of Porto Alegre.

Official Title
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Impact of a Nutritional Intervention Program for Weight Control During Pregnancy

Conditions
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Pregnancy Complications, Weight Gain

Intervention / Treatment
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* Behavioral: Dietary Advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between the 10th and 25th weeks of gestation To concern in the prenatal care group in basic health unit Exclusion Criteria: Pregnant with diseases that require specific treatment at the onset enrollment (HIV, diabetes, hypertension and anemia) Women 36 years or older.

Ages Eligible for Study
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Maximum Age: 35 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: I, Intervention<br> | Behavioral: Dietary Advice<br>* The specific dietary advices according to nutritional status. Main advices: reduction of fat and sugar intake, increase of total energy, dairy intake of vegetables and fruits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequated weight gain during pregnancy. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prematurity, low birth weight and pregnancy complications. |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Prenatal Care, Weight, Nutritional Status