ObesityPhase 3NCT02978105
Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Obesity. A Randomized Controlled Trial
A Phase 3 study testing self-conditioning techniques in people with Obesity, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The investigators hypothesized that hypnosis is an alternative technique that could be applied to help patients with obesity to lose weight. The possibility that a self-conditioning technique (self-hypnosis) added to traditional approach (diet, exercise and behavioral recommendations) will be effective in determining… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- self-conditioning techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2015to Sep 2017
- Phase
- Phase 3
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give written informed consent
- BMI between 35 and 50 kg/m2
- Age 20-70 years
Who cannot join
- Current or previous mental disorders and/or on any psychotropic drug
- Insulin treatment
- Candidates for bariatric surgery
- Current (or discontinued for less than 6 months) treatment with anti-obesity drugs
- Patients at risk of heart failure, edema, ascites (heart diseases, chronic liver diseases, nephrotic syndrome, renal failure)
- Patients with untreated or uncompensated thyroid diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Severe Obesity. A Randomized Controlled Trial
The investigators hypothesized that hypnosis is an alternative technique that could be applied to help patients with obesity to lose weight.
The possibility that a self-conditioning technique (self-hypnosis) added to traditional approach (diet, exercise and behavioral recommendations) will be effective in determining weight loss with respect to the traditional approach in subjects with a body mass index (BMI) between 35 and 50 kg/m2 will be studied.
Read the detailed description
Obesity is a serious health concern. Most lifestyle interventions fail over time; indeed, overeating often involves loss of control and compulsive behaviors.
Hypnosis could increase the ability to control emotional impulses. Self-conditioning techniques borrowed from hypnosis (self-hypnosis) increase self-control and self-management of emotions. Recent hypnosis techniques with a rapid-induction phase allow the trained patients to go into self-hypnosis in a few minutes and to repeat the experience in complete autonomy, employing a short time of the day only.
- Conditions
- Obesity
- Being tested
- self-conditioning techniques, standard care (diet, exercise and behavioral therapy)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-conditioning techniquesOther
Self-hypnosis to increase self-control before meals and every food compulsion episode
standard care (diet, exercise and behavioral therapy)Other
dietary recommendations, exercise recommendations, and behavioral recommendations
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | self-conditioning techniques plus standard care Receives: Other: self-conditioning techniques; Other: standard care (diet, exercise and behavioral therapy) |
| Control | Active comparator | Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations Receives: Other: standard care (diet, exercise and behavioral therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 12 months after randomization
Secondary outcomes (4)
Change in body fat percentage
Dual Energy X-Ray Absorptiometry (DEXA)
Measured: 12 months after randomization
Change in fasting glucose
Measured: 12 months after randomization
Change in insulin circulating values
Measured: 12 months after randomization
Change in quality of life
EuroQol (EQ)-5D [Index and Visual Analog Scale (VAS)
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startFeb 2015
- Primary completionJul 2017
- Study completionSep 2017
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Bo, University of Turin, Italy
- Investigators
- Simona Bo, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978105
- Sponsor's protocol ID
- sbo2015
- Status last verified
- Jan 2018
- First submitted
- 26 Nov 2016
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bo S, Rahimi F, Goitre I, Properzi B, Ponzo V, Regaldo G, Boschetti S, Fadda M, Ciccone G, Abbate Daga G, Mengozzi G, Evangelista A, De Francesco A, Belcastro S, Broglio F. Effects of Self-Conditioning Techniques (Self-Hypnosis) in Promoting Weight Loss in Patients with Severe Obesity: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Sep;26(9):1422-1429. doi: 10.1002/oby.22262.
PubMed 30226009
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Self-conditioning Techniques in Promoting Weight Loss in Patients With Severe Obesity. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02978105
- Acronym / sponsor ID
- sbo2015
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Nov 2016 (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 investigators hypothesized that hypnosis is an alternative technique that could be applied to help patients with obesity to lose weight.
The possibility that a self-conditioning technique (self-hypnosis) added to traditional approach (diet, exercise and behavioral recommendations) will be effective in determining weight loss with respect to the traditional approach in subjects with a body mass index (BMI) between 35 and 50 kg/m2 will be studied.
Detailed description
Obesity is a serious health concern. Most lifestyle interventions fail over time; indeed, overeating often involves loss of control and compulsive behaviors.
Hypnosis could increase the ability to control emotional impulses. Self-conditioning techniques borrowed from hypnosis (self-hypnosis) increase self-control and self-management of emotions. Recent hypnosis techniques with a rapid-induction phase allow the trained patients to go into self-hypnosis in a few minutes and to repeat the experience in complete autonomy, employing a short time of the day only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: self-conditioning techniques, Other: standard care (diet, exercise and behavioral therapy)self-conditioning techniques plus standard care |
| Control | Active comparator | Other: standard care (diet, exercise and behavioral therapy)Standard care: dietary recommendations, exercise recommendations, and behavioral recommendations |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to give written informed consent
- BMI between 35 and 50 kg/m2
- Age 20-70 years
Key exclusion criteria (6 listed)
- Current or previous mental disorders and/or on any psychotropic drug
- Insulin treatment
- Candidates for bariatric surgery
- Current (or discontinued for less than 6 months) treatment with anti-obesity drugs
- Patients at risk of heart failure, edema, ascites (heart diseases, chronic liver diseases, nephrotic syndrome, renal failure)
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 |
|---|---|---|
| self-conditioning techniquesSelf-hypnosis to increase self-control before meals and every food compulsion episode | Other | Experimental |
| standard care (diet, exercise and behavioral therapy)dietary recommendations, exercise recommendations, and behavioral recommendations | Other | Control, Experimental |
Primary outcome
weight loss
Time frame: 12 months after randomization
4 secondary outcomes
Change in body fat percentage
Time frame: 12 months after randomization
Change in fasting glucose
Time frame: 12 months after randomization
Change in insulin circulating values
Time frame: 12 months after randomization
Change in quality of life
Time frame: 12 months after randomization
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 24 Jan 2018.
- Derived from this study: PubMed 30226009Bo S, Rahimi F, Goitre I, Properzi B, Ponzo V, Regaldo G, Boschetti S, Fadda M, Ciccone G, Abbate Daga G, Mengozzi G, Evangelista A, De Francesco A, Belcastro S, Broglio F. Effects of Self-Conditioning Techniques (Self-Hypnosis) in Promoting Weight Loss in Patients with Severe Obesity: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Sep;26(9):1422-1429. doi: 10.1002/oby.22262.
- Individual participant dataSharing planned: No
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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.
Simona Bo, MD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing self-conditioning techniques in people with Obesity, run by University of Turin, Italy 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 3 inclusion and 6 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 24 Jan 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 loss (time frame: 12 months after randomization). 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 NCT02978105, 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 24 Jan 2018.