Clinical trial NCT02769585: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes Mellitus, Type 2
Weight Reduction
Keywords: Obesity
Diabetes Mellitus, Type 2
weight reduction
Lead sponsor: Levenson, David I., M.D.
Sponsor class: INDIV
First posted: 2016-05-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in weight (BMI)
timeFrame: one year
Secondary outcomes:
measure: Waist circumference
timeFrame: One year
measure: hemoglobin A1c
timeFrame: one year
measure: fasting glucose
timeFrame: one year
measure: High versus low imagery
timeFrame: one year
measure: Compliance
timeFrame: one year
measure: Reproducibility of IPQ
timeFrame: one year
measure: Degree of weight loss in obese versus overweight
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: East Coast Medical Associates
name: David I Levenson, MD
role: PRINCIPAL_INVESTIGATOR
References: