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

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

Detailed Description
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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.

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

Conditions
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Obesity, Diabetes Mellitus, Type 2, Weight Reduction

Intervention / Treatment
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* Behavioral: Self-hypnosis
* Behavioral: CDE training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-hypnosis<br>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<br>* Self-hypnosis<br>|
| Active Comparator: CDE training<br>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<br>* standard CDE training for an obese diabetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight (BMI) | Comparison of subject's weight (BMI) from screening visit to last study visit. | one year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Diabetes Mellitus, Type 2, weight reduction