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Trial record 2 of 4 for:    self hypnosis and weight loss

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.

Tracking Information
First Submitted Date  ICMJE May 8, 2016
First Posted Date  ICMJE May 11, 2016
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE July 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2016)
Change in weight (BMI) [ Time Frame: one year ]
Comparison of subject's weight (BMI) from screening visit to last study visit.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics
Official Title  ICMJE Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Diabetes Mellitus, Type 2
  • Weight Reduction
Intervention  ICMJE
  • Behavioral: Self-hypnosis
    Self-hypnosis
  • Behavioral: CDE training
    standard CDE training for an obese diabetic
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: 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.
    Intervention: Behavioral: CDE training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2016)
74
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02769585
Other Study ID Numbers  ICMJE 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: If the need arises we are happy to share data (blinded)
Responsible Party David I. Levenson, MD, Levenson, David I., M.D.
Study Sponsor  ICMJE Levenson, David I., M.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David I Levenson, MD East Coast Medical Associates
PRS Account Levenson, David I., M.D.
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP