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

NCT00969488 | Completed DMC

• 1 other identifier: Pensa Rio - UERJ/FAPERJ
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight

Keywords

matern diet; obese; postpartum; body weight change; Women with overweight

Outcome Measures

Primary Outcomes (1)

• Body weight change

  6 months

Study Arms (2)

high protein diet group

EXPERIMENTAL

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

normal protein diet group

ACTIVE COMPARATOR

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

Interventions

High protein diet OTHER

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).

Also known as: High protein diet group, Normal protein diet group

high protein diet group; normal protein diet group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Chronic illnesses (thyroid disease)

Sponsors & Collaborators

• Rio de Janeiro State University: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator

Study Sites (1)

Hospital Municipal Leonel de Moura Brizola

Mesquita, Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Overweight; Obesity; Body Weight Changes

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Rosely Sichieri, Phd

  Rio de Janeiro State University

  PRINCIPAL INVESTIGATOR

• Maria B Castro, Phd

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: July 1, 2011
• Last Updated: July 20, 2011

Record last verified: 2009-08

Locations

BR (1)