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Completed

NCT Number: NCT00634530

Impact of a Nutritional Intervention Program for Weight Control During Pregnancy

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.

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Key information

Age range

Up to 35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Health Center

Viamão, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Advice

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.

Primary outcomes

  1. Adequated weight gain during pregnancy.

    Time frame: one year

Secondary outcomes

  1. Prematurity, low birth weight and pregnancy complications.

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Mar 13, 2008
Registry last updated
Feb 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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