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Trial record 2 of 4 for:    self hypnosis and weight loss
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Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics

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ClinicalTrials.gov Identifier: NCT02769585
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
David I. Levenson, MD, Levenson, David I., M.D.

Study Description
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Brief Summary:
Randomized study evaluating self-hypnosis versus certified diabetes educator training for weight loss in type 2 diabetics.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Mellitus, Type 2 Weight Reduction Behavioral: Self-hypnosis Behavioral: CDE training Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Self-hypnosis
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
Self-hypnosis
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in weight (BMI) [ Time Frame: one year ]
    Comparison of subject's weight (BMI) from screening visit to last study visit.


Secondary Outcome Measures :
  1. Waist circumference [ Time Frame: One year ]
    change in waist circumference from screening visit to last study date

  2. hemoglobin A1c [ Time Frame: one year ]
    change in Hgb A1c from screening to last study visit

  3. fasting glucose [ Time Frame: one year ]
    change in fasting glucose from screening visit to last study visit

  4. 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.

  5. Compliance [ Time Frame: one year ]
    Assess whether self-reported adherence with the treatment (self-hypnosis or CDE) influenced degree of weight loss

  6. 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.

  7. Degree of weight loss in obese versus overweight [ Time Frame: one year ]
    Determine if starting BMI influenced degree of weight loss.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Type 2 Diabetes
  • BMI greater than 25

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Levenson, David I., M.D.
Investigators
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Principal Investigator: David I Levenson, MD East Coast Medical Associates
More Information
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Responsible Party: David I. Levenson, MD, PI, Levenson, David I., M.D.
ClinicalTrials.gov Identifier: NCT02769585    
Other Study ID Numbers: 1
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If the need arises we are happy to share data (blinded)
Keywords provided by David I. Levenson, MD, Levenson, David I., M.D.:
Obesity
Diabetes Mellitus, Type 2
weight reduction
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Body Weight
Weight Loss
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes