ObesityNCT01686854
Effectiveness of Cognitive Behavioral Therapy vs. Prescriptive Diet in Short and Medium-term Control of Body Weight
A study testing Cognitive Behavioral (B) and Prescriptive Diet (A) in people with Obesity, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Comparison between different treatments of obesity in the short and medium term: prescriptive diet therapy compared to to cognitive-behavioral approach in the treatment of obesity according to the method of clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Cognitive Behavioral (B) and Prescriptive Diet (A)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2007to Jan 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with severe overweight (BMI 27-29.9) or obesity of first step (BMI 30-34.9kg/h2 and obesity of second step (BMI 35-39.9 9kg/h2). Patients with dyslipidemia, hypertension, slight organ damage were eligible in the study; Exclusion Criteria:
- patients treated with anorectic, estrogen or progestin and patients with diabetes or eating disordes were excluded.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Terapia Dell'obesità: Studio Randomizzato Per la Valutazione Dell'Efficacia Della Terapia Cognitivo-comportamentale Versus Dietoterapia Prescrittiva Nel Controllo a Breve e Medio Termine Del Peso Corporeo e Del Rischio Cardiovascolare."
Comparison between different treatments of obesity in the short and medium term: prescriptive diet therapy compared to to cognitive-behavioral approach in the treatment of obesity according to the method of clinical trial.
According to the Italian guidelines on obesity, the target to reach is the weight loss of 10% compared to the initial weight, obtained in six months and maintained for the next 5 years.
The guideline considers six months as the time required to lose weight, but many patients are not able to achieve this result. Since in clinical practice many patients fail to achieve this weight loss in six months, it was decided to extend to 12 months the time to reach the target. As an intermediate goal it has been proposed to achieve a weight loss of at least 5% on respect of the basal weight in six months.
Read the detailed description
The hypotheses to be tested is that the addition of a short CBT, as it can be applied in a public outpatients, is able to improve the percentage of responders and to raise the proportion of subjects able to maintain the result over time.
- Conditions
- Obesity
- Being tested
- Cognitive Behavioral (B), Prescriptive Diet (A)
- Keywords
- cognitive-behavioral approach, obesity treatment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral (B)Behavioural
a 12 months training program in small groups (max 10 persons) about problem solving strategies. Each 90 minute lesson will be given by clinicians, psicologist, dieticians, according cognitive behavioural approach and strategies.
Prescriptive Diet (A)Other
prescribed diet, with a reduction of 500 Kcal for overweight-1° degree obese, and of 800-1000 Kcal for 2° degree obese patients respect caloric requirement, in compliance with Italian guidelines (INRAN 2003).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral (B) | Experimental | a 12 months training program in small groups (max 10 persons) about problem solving strategies. Each 90 minute lesson will be given by clinicians, psicologist, dieticians, according cognitive behavioural approach and strategies. Receives: Behavioral: Cognitive Behavioral (B) |
| Prescriptive Diet (A) | Active comparator | prescribed diet, with a reduction of 500 Kcal for overweight-1° degree obese, and of 800-1000 Kcal for 2° degree obese patients respect caloric requirement, in compliance with Italian guidelines (INRAN 2003). Receives: Other: Prescriptive Diet (A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight reduction by 10% compared to the initial weight to over 12 months achievement of weight loss corresponding to 10% of the initial weight
body weight reduction by 10% compared to the initial weight to over 12 months achievement of weight loss corresponding to 10% of the initial weight in 12 months.
It will be considered responder to therapy who reach such a result in 12 months
Measured: 12 months
Secondary outcomes (3)
body weight reduction by 5% compared to the initial weight
subjects will be considered responder to therapy if they reach such a result in 6 months , even if according Italian guidelines this will be considered failure
Measured: 6 months
cardiovascular risk
cardiovascular risk according definition of Italian "Istituto Superiore di Sanità"
Measured: 6, 12, 24 months
Attrition in the two groups
Measured: 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startMar 2007
- Primary completionJan 2012
- Study completionJan 2013 (estimated)
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.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Muggia, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Chiara Muggia, MD, Principal investigator, Clinica Medica 2a
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686854
- Sponsor's protocol ID
- PSMCM01
- Status last verified
- Sep 2012
- First submitted
- 29 May 2012
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Terapia Dell'obesità: Studio Randomizzato Per la Valutazione Dell'Efficacia Della Terapia Cognitivo-comportamentale Versus Dietoterapia Prescrittiva Nel Controllo a Breve e Medio Termine Del Peso Corporeo e Del Rischio Cardiovascolare."
- ClinicalTrials.gov ID
- NCT01686854
- Acronym / sponsor ID
- PSMCM01
- Conditions
- Obesity
- Keywords
- cognitive-behavioral approach, obesity treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2013 (estimated)
- First posted
- 18 Sep 2012 (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.
Comparison between different treatments of obesity in the short and medium term: prescriptive diet therapy compared to to cognitive-behavioral approach in the treatment of obesity according to the method of clinical trial.
According to the Italian guidelines on obesity, the target to reach is the weight loss of 10% compared to the initial weight, obtained in six months and maintained for the next 5 years.
The guideline considers six months as the time required to lose weight, but many patients are not able to achieve this result. Since in clinical practice many patients fail to achieve this weight loss in six months, it was decided to extend to 12 months the time to reach the target. As an intermediate goal it has been proposed to achieve a weight loss of at least 5% on respect of the basal weight in six months.
Detailed description
The hypotheses to be tested is that the addition of a short CBT, as it can be applied in a public outpatients, is able to improve the percentage of responders and to raise the proportion of subjects able to maintain the result over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral (B) | Experimental | Behavioral: Cognitive Behavioral (B)a 12 months training program in small groups (max 10 persons) about problem solving strategies. Each 90 minute lesson will be given by clinicians, psicologist, dieticians, according cognitive behavioural approach and strategies. |
| Prescriptive Diet (A) | Active comparator | Other: Prescriptive Diet (A)prescribed diet, with a reduction of 500 Kcal for overweight-1° degree obese, and of 800-1000 Kcal for 2° degree obese patients respect caloric requirement, in compliance with Italian guidelines (INRAN 2003). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with severe overweight (BMI 27-29.9) or obesity of first step (BMI 30-34.9kg/h2 and obesity of second step (BMI 35-39.9 9kg/h2). Patients with dyslipidemia, hypertension, slight organ damage were eligible in the study; Exclusion Criteria:
- patients treated with anorectic, estrogen or progestin and patients with diabetes or eating disordes were excluded.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cognitive Behavioral (B)a 12 months training program in small groups (max 10 persons) about problem solving strategies. Each 90 minute lesson will be given by clinicians, psicologist, dieticians, according cognitive behavioural approach and strategies. | Behavioural | Cognitive Behavioral (B) |
| Prescriptive Diet (A)prescribed diet, with a reduction of 500 Kcal for overweight-1° degree obese, and of 800-1000 Kcal for 2° degree obese patients respect caloric requirement, in compliance with Italian guidelines (INRAN 2003). | Other | Prescriptive Diet (A) |
Primary outcome
body weight reduction by 10% compared to the initial weight to over 12 months achievement of weight loss corresponding to 10% of the initial weight
Time frame: 12 months
body weight reduction by 10% compared to the initial weight to over 12 months achievement of weight loss corresponding to 10% of the initial weight in 12 months. It will be considered responder to therapy who reach such a result in 12 months
3 secondary outcomes
body weight reduction by 5% compared to the initial weight
Time frame: 6 months
cardiovascular risk
Time frame: 6, 12, 24 months
Attrition in the two groups
Time frame: 6, 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
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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.
Chiara Muggia, MD principal investigator
Clinica Medica 2a
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral (B) and Prescriptive Diet (A) in people with Obesity, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 2 inclusion and 0 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 18 Sep 2012. 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 Italy. 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?
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?
body weight reduction by 10% compared to the initial weight to over 12 months achievement of weight loss corresponding to 10% of the initial weight (time frame: 12 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 18 Sep 2012.