An interventional study of Self-hypnosis and CDE training in Obesity, Diabetes Mellitus, Type 2 and Weight Reduction, sponsored by Levenson, David I., M.D.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-13.
Sponsored by Levenson, David I., M.D. · Not applicable, Interventional, and Treatment
Randomized study evaluating self-hypnosis versus certified diabetes educator training for weight loss in type 2 diabetics.
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.
6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 74 is close to the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →Levenson, David I., M.D. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Self-hypnosis
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.
Behavioral: CDE training
Self-hypnosis
standard CDE training for an obese diabetic
Change in weight (BMI)
Comparison of subject's weight (BMI) from screening visit to last study visit.
Time frame: one year
Waist circumference
change in waist circumference from screening visit to last study date
Time frame: One year
hemoglobin A1c
change in Hgb A1c from screening to last study visit
Time frame: one year
fasting glucose
change in fasting glucose from screening visit to last study visit
Time frame: 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.
Time frame: one year
Compliance
Assess whether self-reported adherence with the treatment (self-hypnosis or CDE) influenced degree of weight loss
Time frame: 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.
Time frame: one year
Degree of weight loss in obese versus overweight
Determine if starting BMI influenced degree of weight loss.
Time frame: one year
No study locations are listed for this record.
Plan to share: Undecided — If the need arises we are happy to share data (blinded)
No publications or documents are linked to this record.
The record gives a start of Jul 2013, a primary completion of Apr 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Levenson, David I., M.D.