Obesity Clinical Trial
Official title:
Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics
Randomized study evaluating self-hypnosis versus certified diabetes educator training for weight loss in type 2 diabetics.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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