Health and Wellness in Obesity

NCT ID: NCT02102061

Last Updated: 2016-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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multidisciplinary intervention

Group Type EXPERIMENTAL

multidisciplinary intervention

Intervention Type OTHER

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".

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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multidisciplinary intervention

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".

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade de Campinas

UNKNOWN

Sponsor Role collaborator

Universidad Nacional de Buenos Aires

UNKNOWN

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Gualano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno Gualano, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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School of Physical Education and Sport - USP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rosângela Osório

Role: CONTACT

551130912121

Facility Contacts

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Rosângela Osório

Role: primary

551130912121

References

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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.

Reference Type DERIVED
PMID: 30940423 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29214922 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26579524 (View on PubMed)

Other Identifiers

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Health and Wellness in Obesity

Identifier Type: -

Identifier Source: org_study_id

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