ObesityNCT01023126
Obesity and Psychotherapy as an Alternative to Treatment
A study testing Group Psychotherapy in people with Obesity and Therapy, run by Feevale at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 62 yearsHealthy volunteers can take part
- What is being tested?
- Group Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- May 2007to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI >= 30 kg/m2
Who cannot join
- Age less than 25 or more than 62
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro Universirário Feevale
Novo Hamburgo, Rio Grande do Sul, 93510-250
About this study
Official title: Poor Patients Adherence to Exercise and Group Therapy as an Approach to Obesity Treatment
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.
Read the 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.
- Being tested
- Group Psychotherapy
- Keywords
- Obesity, Exercise, Psychotherapy
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group PsychotherapyBehavioural
Group psychotherapy once a week, under a psychiatrist supervision
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Group Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loose
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startMay 2007
- Primary completionAug 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feevale
- Sponsor type
- University, hospital or other
- Investigators
- Cesar L Reichert, PhD MD, Principal investigator, Centro Universitário Feevale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023126
- Sponsor's protocol ID
- 972833
- Status last verified
- Dec 2009
- First submitted
- 1 Dec 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poor Patients Adherence to Exercise and Group Therapy as an Approach to Obesity Treatment
- ClinicalTrials.gov ID
- NCT01023126
- Acronym / sponsor ID
- 972833
- Keywords
- Obesity, Exercise, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- FeevaleUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EO | No intervention | –Exercise three times a week, one under supervision and two freely chosen by the participant |
| EGT | Experimental | Behavioral: Group PsychotherapyExercise three times a week, one under supervision and two freely chosen by the participant |
Who may qualify
- Ages
- 25 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI >= 30 kg/m2
Key exclusion criteria (1 listed)
- Age less than 25 or more than 62
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group PsychotherapyGroup psychotherapy once a week, under a psychiatrist supervision | Behavioural | EGT |
Primary outcome
Weight loose
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2009.
- Centro Universitário Feevale webpageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cesar L Reichert, PhD MD principal investigator
Centro Universitário Feevale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Psychotherapy in people with Obesity and Therapy, run by Feevale at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loose (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2009.