Health and Wellness in Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02102061
• Other study ID #: Health and Wellness in Obesity
• Status: Recruiting
• Phase: N/A
• First received: March 28, 2014
• Last updated: May 2, 2016
• Start date: January 2013

Study information

• Verified date: May 2016
• Source: University of Sao Paulo
• Contact: Rosângela Osório
• Phone: 551130912121
• Email: roosorio[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• 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".

Locations

Country	Name	City	State
Brazil	School of Physical Education and Sport - USP	Sao Paulo

Sponsors (4)

Lead Sponsor	Collaborator
University of Sao Paulo	Federal University of São Paulo, Universidad Nacional de Buenos Aires, Universidade de Campinas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life	will be assessed by quantitative and qualitative research methods	12 months	No
Secondary	physical capacity	will be assessed by an incremental maximal test	12 months	No
Secondary	body composition		12 months	No
Secondary	food pattern and intake	will be assessed by quantitative and qualitative research methods	12 months	No