OverweightIMOAPNCT01202292
Group Motivational Intervention in Overweight/Obese Patients.
A study testing Behavioral (e.g., Psychotherapy, Lifestyle Counseling) in people with Overweight and Obesity, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The overall goal of IMOAP study is to assess whether the efficacy of the healthcare professionals' usual practices, together with a motivational group intervention (delivered by a nurse trained by an expert psychologist), is more effective than an isolated traditional intervention on weight loss and its maintenance in… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Behavioral (e.g., Psychotherapy, Lifestyle Counseling)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2008to Dec 2010
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight (BMI>25) and obese (BMI>30) patients of both sexes, registered in the medical history (MH) or newly diagnosed.
- Aged between 30 and 70 years
- Agreement to participate in the study
Who cannot join
- Patients with severe clinical pathology (bedridden, dementia, advanced neoplasia, etc.)
- Patients with secondary obesity (hypothyroidism, Cushing's disease, etc)
- Patients with severe sensorial disorders capable of interfering with the motivational intervention (severe, uncorrected deafness, severe visual deficit, etc).
- Patients with serious psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
ABS Florida Sud
L'Hospitalet Del Llobregat, Barcelona, 08095
Juan José Rodriguez-Cristóbal, Dr, 934471080, 21002jrc@comb.es
Juan José Rodriguez Cristóbal, Dr
About this study
Official title: Group Motivational Intervention in Overweight/Obese Patients in Primary Prevention of Cardiovascular Disease in the Primary Healthcare Area.
The overall goal of IMOAP study is to assess whether the efficacy of the healthcare professionals' usual practices, together with a motivational group intervention (delivered by a nurse trained by an expert psychologist), is more effective than an isolated traditional intervention on weight loss and its maintenance in overweight and obese patients. Furthermore, the study will evaluate whether this result has a positive impact on quality of life, changes in eating habits, and a reduction in the associated cardiovascular risk factors and overall cardiovascular risk.
Read the detailed description
The global mortality caused by cardiovascular disease increases with weight. The Framingham study showed that obesity is a cardiovascular risk factor independent of other risks such as type 2 diabetes mellitus, dyslipidemia and smoking. Moreover, the main problem in the management of weight-loss is its maintenance, if it is achieved. We have designed a study in two geographically separated groups, one of which would receive the group motivational intervention, and the other one would receive the usual follow up.
- Conditions
- Overweight, Obesity
- Being tested
- Behavioral (e.g., Psychotherapy, Lifestyle Counseling)
- Keywords
- overweight, obesity, motivational intervention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral (e.g., Psychotherapy, Lifestyle Counseling)Behavioural
Also called Control group receives the usual follow up: diet, exercise
Group motivational intervention consist in expert psychologist 32 monthly sessions (group intervention) on top of the diet plus exercise
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether a group motivational intervention, is more efficient than the latter in the treatment of overweight and obesity, for initial weight loss and essentially to achieve sustained normalisation of the weight achieved.
Measured: 26 months
Secondary outcomes (1)
Observe whether this intervention is more effective for reducing cardiovascular risk factors associated to overweight and obesity, and in the overall cardiovascular risk in these patients.
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startJan 2008
- Primary completionOct 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Investigators
- Juan José Roodriguez-Cristóbal, Dr, Principal investigator, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202292
- Sponsor's protocol ID
- PI 070087
- Acronym
- IMOAP
- Status last verified
- Sep 2010
- First submitted
- 31 May 2010
- Last updated
- 1 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rodriguez Cristobal JJ, Panisello Royo JM, Alonso-Villaverde Grote C, Perez Santos JM, Munoz Lloret A, Rodriguez Cortes F, Trave Mercade P, Benavides Marquez F, Marti de la Morena P, Gonzalez Burgillos MJ, Delclos Baulies M, Bleda Fernandez D, Quillama Torres E; IMOAP Group. Group motivational intervention in overweight/obese patients in primary prevention of cardiovascular disease in the primary healthcare area. BMC Fam Pract. 2010 Mar 18;11:23. doi: 10.1186/1471-2296-11-23.
PubMed 20298557
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Motivational Intervention in Overweight/Obese Patients in Primary Prevention of Cardiovascular Disease in the Primary Healthcare Area.
- ClinicalTrials.gov ID
- NCT01202292
- Acronym / sponsor ID
- IMOAP / PI 070087
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obesity, motivational intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 15 Sep 2010 (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.
The overall goal of IMOAP study is to assess whether the efficacy of the healthcare professionals' usual practices, together with a motivational group intervention (delivered by a nurse trained by an expert psychologist), is more effective than an isolated traditional intervention on weight loss and its maintenance in overweight and obese patients. Furthermore, the study will evaluate whether this result has a positive impact on quality of life, changes in eating habits, and a reduction in the associated cardiovascular risk factors and overall cardiovascular risk.
Detailed description
The global mortality caused by cardiovascular disease increases with weight. The Framingham study showed that obesity is a cardiovascular risk factor independent of other risks such as type 2 diabetes mellitus, dyslipidemia and smoking. Moreover, the main problem in the management of weight-loss is its maintenance, if it is achieved. We have designed a study in two geographically separated groups, one of which would receive the group motivational intervention, and the other one would receive the usual follow up.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight (BMI>25) and obese (BMI>30) patients of both sexes, registered in the medical history (MH) or newly diagnosed.
- Aged between 30 and 70 years
- Agreement to participate in the study
Key exclusion criteria (4 listed)
- Patients with severe clinical pathology (bedridden, dementia, advanced neoplasia, etc.)
- Patients with secondary obesity (hypothyroidism, Cushing's disease, etc)
- Patients with severe sensorial disorders capable of interfering with the motivational intervention (severe, uncorrected deafness, severe visual deficit, etc).
- Patients with serious psychiatric disorders
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 |
|---|---|---|
| Behavioral (e.g., Psychotherapy, Lifestyle Counseling)Also: Control group receives the usual follow up: diet, exerciseGroup motivational intervention consist in expert psychologist 32 monthly sessions (group intervention) on top of the diet plus exercise | Behavioural | Lifestyle counseling |
Primary outcome
Determine whether a group motivational intervention, is more efficient than the latter in the treatment of overweight and obesity, for initial weight loss and essentially to achieve sustained normalisation of the weight achieved.
Time frame: 26 months
1 secondary outcome
Observe whether this intervention is more effective for reducing cardiovascular risk factors associated to overweight and obesity, and in the overall cardiovascular risk in these patients.
Time frame: 26 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2010.
- Background: PubMed 20298557Rodriguez Cristobal JJ, Panisello Royo JM, Alonso-Villaverde Grote C, Perez Santos JM, Munoz Lloret A, Rodriguez Cortes F, Trave Mercade P, Benavides Marquez F, Marti de la Morena P, Gonzalez Burgillos MJ, Delclos Baulies M, Bleda Fernandez D, Quillama Torres E; IMOAP Group. Group motivational intervention in overweight/obese patients in primary prevention of cardiovascular disease in the primary healthcare area. BMC Fam Pract. 2010 Mar 18;11:23. doi: 10.1186/1471-2296-11-23.
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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.
Juan José Roodriguez-Cristóbal, Dr principal investigator
Catalan Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral (e.g., Psychotherapy, Lifestyle Counseling) in people with Overweight and Obesity, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Oct 2010. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Jose Rodriguez-Cristóbal, Dr (0034934471080, 21002jrc@comb.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether a group motivational intervention, is more efficient than the latter in the treatment of overweight and obesity, for initial weight loss and essentially to achieve sustained normalisation of the weight achieved. (time frame: 26 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01202292, which also lists 1 linked publication.
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 1 Oct 2010.