Impact of a Nutritional Intervention Program for Weight Control During Pregnancy
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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 |
- 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 ]
| 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 |
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| Brazil | |
| Health Center | |
| Viamão, Rio Grande do Sul, Brazil | |
| 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 May 16, 2013