Obesity and Psychotherapy as an Alternative to Treatment | NCT01023126

Studies
Obesity and Psychotherapy as an Alternative to Treatment

NCT01023126

Sponsor

Feevale

Status

Completed

Last Update Posted

Dec 2, 2009Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Obesity
Therapy

Interventions

Group Psychotherapy

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Aug 2007Actual

Completion Date

Sep 2009Actual

First Submitted Date

Dec 1, 2009

First Submission Date that Met QC Criteria

Dec 1, 2009

First Posted Date

Dec 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2009

Last Update Posted Date

Dec 2, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Adherence to obesity treatment programs has been a limiting factor to good results in loosing weight. This study aimed to verify if obese subjects submitted to a physical exercise program and group psychotherapy would have a greater adherence, than obese people exercising only.

Detailed Description

The sample was forty people, both genders, mean age: 42,2 ± 10,7 years old. Physical exercise consisted of walking and stretching three times a week, during 50 minutes, with intensity verified by the Borg Scale, during three months. One of the days were supervised by the authors while two were freely chosen by the participant, without supervision. The verified variables were: total body mass, height, body mass index, physical activity level, caloric expenditure, waist circumference and fat percentile. Half of the sample participated of group psychotherapy once weekly.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EO	No Intervention	Exercise three times a week, one under supervision and two freely chosen by the participant
EGT	Experimental	Exercise three times a week, one under supervision and two freely chosen by the participant	Behavioral: Group Psychotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group Psychotherapy	Behavioral	Group psychotherapy once a week, under a psychiatrist supervision	EGT

Measure	Description	Time Frame
Weight loose		three months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI >= 30 kg/m2

Exclusion Criteria:

Age less than 25 or more than 62

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

62 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cesar L Reichert, PhD MD	Centro Universitário Feevale	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Universirário Feevale		Novo Hamburgo	Rio Grande do Sul	93510-250	Brazil

Label	URL
Centro Universitário Feevale webpage	View source

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D009043	Motor Activity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011615	Psychotherapy, Group

Ancestor Terms

ID	Term
D012960	Socioenvironmental Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided