Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02769585|
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : May 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obesity Diabetes Mellitus, Type 2 Weight Reduction||Behavioral: Self-hypnosis Behavioral: CDE training||Not Applicable|
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®. 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) 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
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.
Active Comparator: CDE training
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
standard CDE training for an obese diabetic
- Change in weight (BMI) [ Time Frame: one year ]Comparison of subject's weight (BMI) from screening visit to last study visit.
- Waist circumference [ Time Frame: One year ]change in waist circumference from screening visit to last study date
- hemoglobin A1c [ Time Frame: one year ]change in Hgb A1c from screening to last study visit
- fasting glucose [ Time Frame: one year ]change in fasting glucose from screening visit to last study visit
- High versus low imagery [ Time Frame: one year ]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.
- Compliance [ Time Frame: one year ]Assess whether self-reported adherence with the treatment (self-hypnosis or CDE) influenced degree of weight loss
- Reproducibility of IPQ [ Time Frame: one year ]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.
- Degree of weight loss in obese versus overweight [ Time Frame: one year ]Determine if starting BMI influenced degree of weight loss.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769585
|Principal Investigator:||David I Levenson, MD||East Coast Medical Associates|