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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Complications; Weight Gain
• Intervention / Treatment: Behavioral: Dietary Advice

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Viamão, Rio Grande do Sul, Brazil
      • Health center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: I, 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Investigators: Principal Investigator: Márcia R Vitolo, Doctor, Federal University of Health Sciences of Porto Alegre

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: March 10, 2008
• First Submitted That Met QC Criteria: March 12, 2008
• First Posted (Estimate): March 13, 2008

Study Record Updates

• Last Update Posted (Estimate): February 4, 2009
• Last Update Submitted That Met QC Criteria: February 3, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Pregnancy; Prenatal Care; Weight; Nutritional Status
• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Weight Gain; Pregnancy Complications
• Other Study ID Numbers: vitolo4