ObesityNCT02769585
Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics
A study testing Self-hypnosis and CDE training in people with Obesity and Diabetes Mellitus, Type 2, run by Levenson, David I., M.D..
Trial summary
Randomized study evaluating self-hypnosis versus certified diabetes educator training for weight loss in type 2 diabetics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2, Weight Reduction
- What is being tested?
- Self-hypnosis and CDE training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Apr 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 2 Diabetes
- BMI greater than 25
Who cannot join
- pregnant women of of childbearing age
- currently taking weight loss medications
- enrolled in another clinical trial
- currently taking medications for depression or anxiety
- currently taking Prednisone >7.5 mg day
About this study
Randomized study evaluating self-hypnosis versus certified diabetes educator training for weight loss in type 2 diabetics.
Read the detailed description
Study Subjects: Approximately 74 type II diabetics will be randomized. Key inclusion criteria: overweight (BMI≥25), motivated to lose weight, and are at least 18 years of age.
Key exclusion criteria: pregnant women or women of childbearing age, currently taking medications for weight loss, enrolled in another clinical trial, or planning on having bariatric surgery. Any patient who is taking medication prescribed by a physician for depression, anxiety, or any other psychiatric disorder will be excluded. Patients on glucocorticoids in excess of Prednisone 7.5 mg or equivalent will also be excluded.
Study Design: All patients who pass screening will be administered the IPQ Test®[6]. This test stratifies patients on how they use their imagination, an important factor necessary to reach their goals. This is predictive of their potential to "persist" toward agreed upon goals. Patients will be divided into groups as follows: (Raw score 49-96 = high responders; Raw score 0-48 = Low responders).
Ultimately, subjects will be divided into four groups: The assignment of "high" versus "low" responders will be based on the results of the IPQ® test. Subjects will then be randomly assigned to intervention versus control in a 1:1 fashion. Optimally, there should be equal numbers in each group; however, the group sizes may be unequal depending on the relative proportions of high versus low responders. The four groups will be as follows:
Group I (high responders) will receive self-hypnosis using the GIFT™ (Goal Image Focusing Technique)[7] as the main means of autosuggestion and self/group motivation to lose weight.
Group II (low responders) will receive self-hypnosis (without the GIFT™ system) and self/group motivation to lose weight.
Group III (high responders) will receive standard nutrition, diet, and exercise counseling by a CDE (Certified Diabetes Educator) to serve as a control group for Group I.
Group IV (low responders) will receive standard nutrition, diet, and exercise counseling by a CDE (Certified Diabetes Educator) to serve as a control for group II.
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Weight Reduction
- Being tested
- Self-hypnosis, CDE training
- Keywords
- Obesity, Diabetes Mellitus, Type 2, weight reduction
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-hypnosisBehavioural
Self-hypnosis
CDE trainingBehavioural
standard CDE training for an obese diabetic
| Study group | Role | What they receive |
|---|---|---|
| Self-hypnosis | Experimental | Subjects underwent two group sessions one week apart with a certified hypnotherapist to teach them the process of self-hypnosis for the purpose of attaining weight loss. Subjects were asked to perform self-hypnosis once or twice a day for the duration of the one year trial. Receives: Behavioral: Self-hypnosis |
| CDE training | Active comparator | Subjects underwent two group sessions one week apart with a certified diabetes educator to teach them re: diet and nutrition specifically as regards to a diabetic striving to lose weight. Subjects were asked to remain compliant with dietary restrictions for the duration of the one year trial. Receives: Behavioral: CDE training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight (BMI)
Comparison of subject's weight (BMI) from screening visit to last study visit.
Measured: one year
Secondary outcomes (7)
Waist circumference
change in waist circumference from screening visit to last study date
Measured: One year
hemoglobin A1c
change in Hgb A1c from screening to last study visit
Measured: one year
fasting glucose
change in fasting glucose from screening visit to last study visit
Measured: one year
High versus low imagery
Comparison of subjects who scored high (>=48) or low (<= 47) on the IPQ questionnaire which was administered at the screening visit to all subjects. IPQ test can be found here Harte, Richard and Coller, Alan R. The Harte Coller IPQ® Inventory, Experimental Form E, New York/ The Harte Center for Hypnosis, 1986.
Measured: one year
Compliance
Assess whether self-reported adherence with the treatment (self-hypnosis or CDE) influenced degree of weight loss
Measured: one year
Reproducibility of IPQ
Compare results of IPQ test administered at screening with identical test administered at final study visit one year later. To assess how many subjects changed categorization between high (>=48) or low (<=47) responders. Information on IPQ can be found here: Harte, Richard and Coller, Alan R. The Harte Coller IPQ® Inventory, Experimental Form E, New York/ The Harte Center for Hypnosis, 1986.
Measured: one year
Degree of weight loss in obese versus overweight
Determine if starting BMI influenced degree of weight loss.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJul 2013
- Primary completionApr 2015
- Study completionApr 2015
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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Levenson, David I., M.D.
- Responsible party
- Principal investigator, David I. Levenson, MD, Levenson, David I., M.D.
- Investigators
- David I Levenson, MD, Principal investigator, East Coast Medical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769585
- Sponsor's protocol ID
- 1
- Status last verified
- May 2016
- First submitted
- 8 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: If the need arises we are happy to share data (blinded)
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics
- ClinicalTrials.gov ID
- NCT02769585
- Acronym / sponsor ID
- 1
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Weight Reduction
- Keywords
- Obesity, Diabetes Mellitus, Type 2, weight reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Levenson, David I., M.D.
- Study start
- Jul 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 May 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.
Randomized study evaluating self-hypnosis versus certified diabetes educator training for weight loss in type 2 diabetics.
Detailed description
Study Subjects: Approximately 74 type II diabetics will be randomized. Key inclusion criteria: overweight (BMI≥25), motivated to lose weight, and are at least 18 years of age.
Key exclusion criteria: pregnant women or women of childbearing age, currently taking medications for weight loss, enrolled in another clinical trial, or planning on having bariatric surgery. Any patient who is taking medication prescribed by a physician for depression, anxiety, or any other psychiatric disorder will be excluded. Patients on glucocorticoids in excess of Prednisone 7.5 mg or equivalent will also be excluded.
Study Design: All patients who pass screening will be administered the IPQ Test®[6]. This test stratifies patients on how they use their imagination, an important factor necessary to reach their goals. This is predictive of their potential to "persist" toward agreed upon goals. Patients will be divided into groups as follows: (Raw score 49-96 = high responders; Raw score 0-48 = Low responders).
Ultimately, subjects will be divided into four groups: The assignment of "high" versus "low" responders will be based on the results of the IPQ® test. Subjects will then be randomly assigned to intervention versus control in a 1:1 fashion. Optimally, there should be equal numbers in each group; however, the group sizes may be unequal depending on the relative proportions of high versus low responders. The four groups will be as follows:
Group I (high responders) will receive self-hypnosis using the GIFT™ (Goal Image Focusing Technique)[7] as the main means of autosuggestion and self/group motivation to lose weight.
Group II (low responders) will receive self-hypnosis (without the GIFT™ system) and self/group motivation to lose weight.
Group III (high responders) will receive standard nutrition, diet, and exercise counseling by a CDE (Certified Diabetes Educator) to serve as a control group for Group I.
Group IV (low responders) will receive standard nutrition, diet, and exercise counseling by a CDE (Certified Diabetes Educator) to serve as a control for group II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-hypnosis | Experimental | Behavioral: Self-hypnosisSubjects underwent two group sessions one week apart with a certified hypnotherapist to teach them the process of self-hypnosis for the purpose of attaining weight loss. Subjects were asked to perform self-hypnosis once or twice a day for the duration of the one year trial. |
| CDE training | Active comparator | Behavioral: CDE trainingSubjects underwent two group sessions one week apart with a certified diabetes educator to teach them re: diet and nutrition specifically as regards to a diabetic striving to lose weight. Subjects were asked to remain compliant with dietary restrictions for the duration of the one year trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Type 2 Diabetes
- BMI greater than 25
Key exclusion criteria (5 listed)
- pregnant women of of childbearing age
- currently taking weight loss medications
- enrolled in another clinical trial
- currently taking medications for depression or anxiety
- currently taking Prednisone >7.5 mg day
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-hypnosisSelf-hypnosis | Behavioural | Self-hypnosis |
| CDE trainingstandard CDE training for an obese diabetic | Behavioural | CDE training |
Primary outcome
Change in weight (BMI)
Time frame: one year
Comparison of subject's weight (BMI) from screening visit to last study visit.
7 secondary outcomes
Waist circumference
Time frame: One year
hemoglobin A1c
Time frame: one year
fasting glucose
Time frame: one year
High versus low imagery
Time frame: one year
Compliance
Time frame: one year
Reproducibility of IPQ
Time frame: one year
Degree of weight loss in obese versus overweight
Time frame: one year
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 13 May 2016.
- Individual participant dataSharing planned: Undecided. If the need arises we are happy to share data (blinded)
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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.
David I Levenson, MD principal investigator
East Coast Medical Associates
Questions about this trial
What is this clinical trial studying?
A study testing Self-hypnosis and CDE training in people with Obesity and Diabetes Mellitus, Type 2, run by Levenson, David I., M.D..
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 5 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in weight (BMI) (time frame: one year). 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 13 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.