Impact of a Nutritional Intervention Program for Weight Control During Pregnancy

NCT ID: NCT00634530

Last Updated: 2009-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-01-31

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.

Detailed Description

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Conditions

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Pregnancy Complications Weight Gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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I, Intervention

Group Type OTHER

Dietary Advice

Intervention Type BEHAVIORAL

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.

Interventions

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Dietary Advice

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.

Intervention Type BEHAVIORAL

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.
Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Federal University of Health Science of Porto Alegre

Principal Investigators

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Márcia R Vitolo, Doctor

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Sciences of Porto Alegre

Locations

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Health Center

Viamão, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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vitolo4

Identifier Type: -

Identifier Source: org_study_id

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