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 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|
- Adequated weight gain during pregnancy. [ Time Frame: one year ] [ Designated as safety issue: No ]
- Prematurity, low birth weight and pregnancy complications. [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634530
|Viamão, Rio Grande do Sul, Brazil|
|Principal Investigator:||Márcia R Vitolo, Doctor||Federal University of Health Sciences of Porto Alegre|