The Effect of a High Protein Diet on Body Weight Change During Post-partum

This study has been completed.
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by:
Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT00969488
First received: August 31, 2009
Last updated: July 19, 2011
Last verified: August 2009
  Purpose

Nearly 20% of women do not return to their pré-gestacional body weight. The purpose of this study is to investigate the effect of diet and socio-demographics factors during gestation and postpartum period to body weight change after delivery. This is a clinical trial with 180 women interviewed at 1 (baseline), 2, 3, 4, 5 and 6 months postpartum. The dietary data were obtained by employing the Food Consumption Frequency Questionnaire with reference to the first and sixth months of postpartum.


Condition Intervention
Overweight
Other: High protein diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: The Effect of a High Protein Diet on Body Weight Change and Body Composition During Post-partum: Randomized Clinical Trial Study

Resource links provided by NLM:


Further study details as provided by Rio de Janeiro State University:

Primary Outcome Measures:
  • Body weight change [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: February 2009
Study Completion Date: July 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high protein diet group

Women in high protein diet will be stimulate to consumption of high protein foods and restrict the consumption of carbohydrates in the experimental group. The women in the intervention group will be incentivized to substitute breads and pastas for high protein foods (legumes, milk and its derivatives, eggs, fish, and lean meats). The experimental groups will also receive six cans of sardine to increase the women's commitment to the study.

Both women group will receive a nutritional plan based on an 1800 kcal diet.

Other: High protein diet

INTERVENTION is to stimulate the consumption of high protein foods and restrict the consumption of carbohydrates in the experimental group.

The women in the intervention group will be incentivized to substitute breads and pastas for high protein foods (legumes, milk and its derivatives, eggs, fish, and lean meats).

Other Names:
  • High protein diet group
  • Normal protein diet group
Active Comparator: normal protein diet group
The control group will receive a diet to lose weight with norma protein intake and will receive 2kg of pasta to increase the women's commitment to the study. The nutritional plan based on an 1800 kcal diet.
Other: High protein diet

INTERVENTION is to stimulate the consumption of high protein foods and restrict the consumption of carbohydrates in the experimental group.

The women in the intervention group will be incentivized to substitute breads and pastas for high protein foods (legumes, milk and its derivatives, eggs, fish, and lean meats).

Other Names:
  • High protein diet group
  • Normal protein diet group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women with body mass index (BMI) ≥ 26 kg/m2
  • Age between 18 and 45 years

Exclusion Criteria:

  • Chronic illnesses (thyroid disease)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969488

Locations
Brazil
Hospital Municipal Leonel de Moura Brizola
Mesquita, Rio de Janeiro, Brazil
Sponsors and Collaborators
Rio de Janeiro State University
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
Principal Investigator: Rosely Sichieri, Phd Rio de Janeiro State University
Principal Investigator: Maria B Castro, Phd Universidade Federal do Rio de Janeiro
  More Information

No publications provided

Responsible Party: Rosely Sichieri, Universidade do Estado do Rio de Janeiro. Departamento de Epidemiologia
ClinicalTrials.gov Identifier: NCT00969488     History of Changes
Other Study ID Numbers: Pensa Rio - UERJ/FAPERJ
Study First Received: August 31, 2009
Last Updated: July 19, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Rio de Janeiro State University:
matern diet
obese
postpartum
body weight change
Women with overweight

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014