NCT02102061

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

4 years

First QC Date

March 28, 2014

Last Update Submit

May 2, 2016

Conditions

ObesityOverweight

Keywords

overweightexercisenutritionphilosophy

Outcome Measures

Primary Outcomes (1)

  • quality of life

    will be assessed by quantitative and qualitative research methods

    12 months

Secondary Outcomes (3)

  • physical capacity

    12 months

  • body composition

    12 months

  • food pattern and intake

    12 months

Study Arms (2)

multidisciplinary intervention

EXPERIMENTAL
Other: multidisciplinary intervention

control

NO INTERVENTION

Interventions

multidisciplinary interventionOTHER

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".

multidisciplinary intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physical Education and Sport - USP

São Paulo, São Paulo, 05508030, Brazil

RECRUITING

Related Publications (3)

  • 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.

    PMID: 30940423DERIVED

  • 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.

    PMID: 29214922DERIVED

  • 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.

    PMID: 26579524DERIVED

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Bruno Gualano, Professor

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosângela Osório

CONTACT

551130912121roosorio@usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 2, 2014

Study Start

January 1, 2013

Primary Completion

January 1, 2017

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

BR(1)