Clinical trial NCT02102061: Health and Wellness in Obesity
Official title: Health and Wellness in Obesity: Exploring the Efficacy of a New Multidisciplinary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Overweight
Keywords: overweight
exercise
nutrition
philosophy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Universidade de Campinas
name: Universidad Nacional de Buenos Aires
name: Federal University of São Paulo
First posted: 2014-04-02
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The present study aims to explore the effects of a novel multidisciplinary non-pharmacological intervention designed to improve health parameters and well-being in overweight and obese women. The proposed program is health- and quality of life-oriented, without a focus on weight loss, following the philosophical principles from "Health at Every Size", and may provide an alternative mode of intervention to the traditional one, which is focused on the concept of "weight loss at any cost". To evaluate the efficacy of the intervention, a mixed-method design combining both qualitative and quantitative assessments will be applied.


Eligibility criteria: Inclusion Criteria:

* overweight (BMI \> 25 kg/m²)
* without using "anti-obesity" drugs
* not engaged in other interventions to control weight

Exclusion Criteria:

* BMI \< 25 kg/m²
* under pharmacological treatment
* under any type of intervention to control weight
* inability to exercise

Primary outcomes:
measure: quality of life
timeFrame: 12 months
Secondary outcomes:
measure: physical capacity
timeFrame: 12 months
measure: body composition
timeFrame: 12 months
measure: food pattern and intake
timeFrame: 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: School of Physical Education and Sport - USP
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sabatini F, Ulian MD, Perez I, Pinto AJ, Vessoni A, Aburad L, Benatti FB, Lopes de Campos-Ferraz P, Coelho D, de Morais Sato P, Roble OJ, Unsain RF, Schuster RC, Gualano B, Scagliusi FB. Eating Pleasure in a Sample of Obese Brazilian Women: A Qualitative Report of an Interdisciplinary Intervention Based on the Health at Every Size Approach. J Acad Nutr Diet. 2019 Sep;119(9):1470-1482. doi: 10.1016/j.jand.2019.01.006. Epub 2019 Mar 30.
citation: Ulian MD, Gualano B, Benatti FB, de Campos-Ferraz PL, Coelho D, Roble OJ, Sabatini F, Perez I, Aburad L, Pinto AJ, Vessoni A, Victor JC, Lima VK, Unsain RF, de Morais Sato P, Rogero MM, Toporcov TN, Scagliusi FB. The design and rationale of an interdisciplinary, non-prescriptive, and Health at Every Size(R)-based clinical trial: The "Health and Wellness in Obesity" study. Nutr Health. 2017 Dec;23(4):261-270. doi: 10.1177/0260106017731260.
citation: Ulian MD, Benatti FB, de Campos-Ferraz PL, Roble OJ, Unsain RF, de Morais Sato P, Brito BC, Murakawa KA, Modesto BT, Aburad L, Bertuzzi R, Lancha AH Jr, Gualano B, Scagliusi FB. The Effects of a "Health at Every Size((R))"-Based Approach in Obese Women: A Pilot-Trial of the "Health and Wellness in Obesity" Study. Front Nutr. 2015 Oct 27;2:34. doi: 10.3389/fnut.2015.00034. eCollection 2015.