Impact of a Nutritional Intervention Program for Weight Control During Pregnancy
Primary Purpose
Pregnancy Complications, Weight Gain
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dietary Advice
Sponsored by
About this trial
This is an interventional health services research trial for Pregnancy Complications focused on measuring Pregnancy, Prenatal Care, Weight, Nutritional Status
Eligibility 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.
Sites / Locations
- Health Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
I, Intervention
Arm Description
Outcomes
Primary Outcome Measures
Adequated weight gain during pregnancy.
Secondary Outcome Measures
Prematurity, low birth weight and pregnancy complications.
Full Information
NCT ID
NCT00634530
First Posted
March 10, 2008
Last Updated
February 3, 2009
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT00634530
Brief Title
Impact of a Nutritional Intervention Program for Weight Control During Pregnancy
Official Title
Impact of a Nutritional Intervention Program for Weight Control During Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of Health Science of Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications, Weight Gain
Keywords
Pregnancy, Prenatal Care, Weight, Nutritional Status
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
318 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I, Intervention
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Dietary Advice
Intervention Description
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 Outcome Measure Information:
Title
Adequated weight gain during pregnancy.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Prematurity, low birth weight and pregnancy complications.
Time Frame
one year
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Márcia R Vitolo, Doctor
Organizational Affiliation
Federal University of Health Sciences of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Center
City
Viamão
State/Province
Rio Grande do Sul
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Impact of a Nutritional Intervention Program for Weight Control During Pregnancy
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