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Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics

Primary Purpose

Obesity, Diabetes Mellitus, Type 2, Weight Reduction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-hypnosis
CDE training
Sponsored by
Levenson, David I., M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Diabetes Mellitus, Type 2, weight reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Self-hypnosis

    CDE training

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in weight (BMI)
    Comparison of subject's weight (BMI) from screening visit to last study visit.

    Secondary Outcome Measures

    Waist circumference
    change in waist circumference from screening visit to last study date
    hemoglobin A1c
    change in Hgb A1c from screening to last study visit
    fasting glucose
    change in fasting glucose from screening visit to last study visit
    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.
    Compliance
    Assess whether self-reported adherence with the treatment (self-hypnosis or CDE) influenced degree of weight loss
    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.
    Degree of weight loss in obese versus overweight
    Determine if starting BMI influenced degree of weight loss.

    Full Information

    First Posted
    May 8, 2016
    Last Updated
    May 12, 2016
    Sponsor
    Levenson, David I., M.D.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02769585
    Brief Title
    Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics
    Official Title
    Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Levenson, David I., M.D.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Diabetes Mellitus, Type 2, Weight Reduction
    Keywords
    Obesity, Diabetes Mellitus, Type 2, weight reduction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    74 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Self-hypnosis
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    CDE training
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Behavioral
    Intervention Name(s)
    Self-hypnosis
    Intervention Description
    Self-hypnosis
    Intervention Type
    Behavioral
    Intervention Name(s)
    CDE training
    Intervention Description
    standard CDE training for an obese diabetic
    Primary Outcome Measure Information:
    Title
    Change in weight (BMI)
    Description
    Comparison of subject's weight (BMI) from screening visit to last study visit.
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Waist circumference
    Description
    change in waist circumference from screening visit to last study date
    Time Frame
    One year
    Title
    hemoglobin A1c
    Description
    change in Hgb A1c from screening to last study visit
    Time Frame
    one year
    Title
    fasting glucose
    Description
    change in fasting glucose from screening visit to last study visit
    Time Frame
    one year
    Title
    High versus low imagery
    Description
    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
    Title
    Compliance
    Description
    Assess whether self-reported adherence with the treatment (self-hypnosis or CDE) influenced degree of weight loss
    Time Frame
    one year
    Title
    Reproducibility of IPQ
    Description
    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
    Title
    Degree of weight loss in obese versus overweight
    Description
    Determine if starting BMI influenced degree of weight loss.
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David I Levenson, MD
    Organizational Affiliation
    East Coast Medical Associates
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    If the need arises we are happy to share data (blinded)

    Learn more about this trial

    Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics

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