Impact of a Nutritional Intervention Program for Weight Control During Pregnancy

Pregnancy Complications Clinical Trial

Official title:

Impact of a Nutritional Intervention Program for Weight Control During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634530
• Other study ID #: vitolo4
• Status: Completed
• Phase: N/A
• First received: March 10, 2008
• Last updated: February 3, 2009
• Start date: September 2007
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: January 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Body Weight
• Pregnancy Complications
• Weight Gain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Brazil	Health Center	Viamão	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequated weight gain during pregnancy.		one year	No
Secondary	Prematurity, low birth weight and pregnancy complications.		one year	No