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

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

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Sponsors and Collaborators

Levenson, David I., M.D.

Investigators

• Principal Investigator: David I Levenson, MD; East Coast Medical Associates

More Information

• 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
• 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:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Body Weight; Weight Loss; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes