Impact of a Nutritional Intervention Program for Weight Control During Pregnancy

This study has been completed.
Sponsor:
Information provided by:
Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier:
NCT00634530
First received: March 10, 2008
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention
Pregnancy Complications
Weight Gain
Behavioral: Dietary Advice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of a Nutritional Intervention Program for Weight Control During Pregnancy

Resource links provided by NLM:


Further study details as provided by Federal University of Health Science of Porto Alegre:

Primary Outcome Measures:
  • Adequated weight gain during pregnancy. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prematurity, low birth weight and pregnancy complications. [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 318
Study Start Date: September 2007
Study Completion Date: January 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634530

Locations
Brazil
Health Center
Viamão, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Investigators
Principal Investigator: Márcia R Vitolo, Doctor Federal University of Health Sciences of Porto Alegre
  More Information

No publications provided

Responsible Party: Márcia Regina Vitolo, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT00634530     History of Changes
Other Study ID Numbers: vitolo4
Study First Received: March 10, 2008
Last Updated: February 3, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Health Science of Porto Alegre:
Pregnancy
Prenatal Care
Weight
Nutritional Status

Additional relevant MeSH terms:
Pregnancy Complications
Weight Gain
Food Habits
Body Weight Changes
Body Weight
Signs and Symptoms
Habits

ClinicalTrials.gov processed this record on April 14, 2014