Impact of a Nutritional Intervention Program for Weight Control During Pregnancy

NCT00634530 | Completed

• 1 other identifier: vitolo4
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Complications; Weight Gain

Keywords

Pregnancy; Prenatal Care; Weight; Nutritional Status

Outcome Measures

Primary Outcomes (1)

• Adequated weight gain during pregnancy.

  one year

Secondary Outcomes (1)

• Prematurity, low birth weight and pregnancy complications.

  one year

Study Arms (1)

I, Intervention

OTHER

Behavioral: Dietary Advice

Interventions

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.

I, Intervention

Eligibility Criteria

• Age: Up to 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women between the 10th and 25th weeks of gestation
• To concern in the prenatal care group in basic health unit

You may not qualify if:

• Pregnant with diseases that require specific treatment at the onset enrollment (HIV, diabetes, hypertension and anemia)
• Women 36 years or older.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Health Center

Viamão, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Pregnancy Complications; Weight Gain; Body Weight

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Márcia R Vitolo, Doctor

  Federal University of Health Sciences of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 13, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: January 1, 2009
• Last Updated: February 4, 2009

Record last verified: 2009-02

Locations

BR (1)