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Health and Wellness in Obesity

Primary Purpose

Obesity, Overweight

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

multidisciplinary intervention

About this trial

This is an interventional health services research trial for Obesity focused on measuring overweight, exercise, nutrition, philosophy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

School of Physical Education and Sport - USPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

multidisciplinary intervention

control

Arm Description

Outcomes

Primary Outcome Measures

quality of life

will be assessed by quantitative and qualitative research methods

Secondary Outcome Measures

physical capacity

will be assessed by an incremental maximal test

body composition

food pattern and intake

will be assessed by quantitative and qualitative research methods

Full Information

NCT ID

NCT02102061

First Posted

March 28, 2014

Last Updated

May 2, 2016

Sponsor

University of Sao Paulo

Collaborators

Universidade de Campinas, Universidad Nacional de Buenos Aires, Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02102061

Brief Title

Health and Wellness in Obesity

Official Title

Health and Wellness in Obesity: Exploring the Efficacy of a New Multidisciplinary Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

Collaborators

Universidade de Campinas, Universidad Nacional de Buenos Aires, Federal University of São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight

Keywords

overweight, exercise, nutrition, philosophy

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

multidisciplinary intervention

Arm Type

Experimental

Arm Title

control

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

multidisciplinary intervention

Intervention Description

a health- and quality of life-oriented program comprising exercise, nutrition advices, and philosophy meetings, without a focus on weight loss, following the philosophical principles from "Health at Every Size".

Primary Outcome Measure Information:

Title

quality of life

Description

will be assessed by quantitative and qualitative research methods

Time Frame

12 months

Secondary Outcome Measure Information:

Title

physical capacity

Description

will be assessed by an incremental maximal test

Time Frame

12 months

Title

body composition

Time Frame

12 months

Title

food pattern and intake

Description

will be assessed by quantitative and qualitative research methods

Time Frame

12 months

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rosângela Osório

Phone

551130912121

roosorio@usp.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruno Gualano, Professor

Organizational Affiliation

University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Physical Education and Sport - USP

City

Sao Paulo

ZIP/Postal Code

05508030

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rosângela Osório

Phone

551130912121

roosorio@usp.br

First Name & Middle Initial & Last Name & Degree

Bruno Gualano, Professor

12. IPD Sharing Statement

Citations:

PubMed Identifier

30940423

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.

Results Reference

derived

PubMed Identifier

29214922

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.

Results Reference

derived

PubMed Identifier

26579524

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.

Results Reference

derived

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Health and Wellness in Obesity

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