The Effect of a High Protein Diet on Body Weight Change and Body Composition During Post-partum: Randomized Clinical Trial Study

SUBJECTS AND METHODS

1. STUDY DESIGN AND SUBJECTS This randomized clinical trial study examined the efficacy of two weight loss diets with different intake of protein by kg of body weight in postpartum women that had at Hospital Leonel de Moura Brizola do Município de Mesquita, situated at Rio de Janeiro State. Inclusion criterion were women with body mass index (BMI) ≥ 26 kg/m2, age between 18 and 45 years, without chronic illnesses (thyroid disease).
2. COLLECTION OF DATA:

2.1- Collection: Maternity. The women with BMI ≥ 26 kg/m2 are invited to participate in the study at the maternity until 3 days after child birth. The women that chose to participate will be scheduled to come in for their first visit approximately one month after the birth of their child. The visits will occur in the Hospital Municipal Leonel de Moura Brizola and the evaluations of body composition by DXA will take place at the University of the Rio de Janeiro State. The room at the University prepared for the visits will provide comfort for the mothers and their babies. The place picked for the participants of this study is the hospital at which the sponsor works and because it consists of low income women with high risk of obesity post partum.

In this occasion, dietary intake, antropometrics and socio-demographic measures were been taken. The women will answer their clinical history, foodnutrient intake of the last six months prior to the birth of their child, breastfeeding, their social-demographics status, and life style (education, civil state, age, work, living conditions, race, smoking, and consumption of alcohol). The participant's race will be determined by skin color given by the participants themselves as well as the interviewer. Body weight and composition and height will be measured using an electronic scale (Tanita, Model BWB-627A) stadiometer (Holtain Limited, Crymych, United Kingdom), respectively.

2.2- First month of postpartum: cohort baseline. At this moment, the women will receive information about the study, the procedures that will take place, the objectives of the study, and will sign the terms of consent. Only the women that show up to this visit will form the cohort for the randomized diet. The participants of the study will be allocated randomly into a control and experimental group. After the allocation, the women will receive a program to lose weight as will be discussed in section 3- Intervention.