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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769585
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: May 8, 2016
• Last updated: May 12, 2016
• Start date: July 2013
• Est. completion date: April 2015

Study information

• Verified date: May 2016
• Source: Levenson, David I., M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Weight Loss
• Weight Reduction

Intervention

Behavioral:
• Self-hypnosis
Self-hypnosis
• CDE training
standard CDE training for an obese diabetic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Levenson, David I., M.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight (BMI)	Comparison of subject's weight (BMI) from screening visit to last study visit.	one year	No
Secondary	Waist circumference	change in waist circumference from screening visit to last study date	One year	No
Secondary	hemoglobin A1c	change in Hgb A1c from screening to last study visit	one year	No
Secondary	fasting glucose	change in fasting glucose from screening visit to last study visit	one year	No
Secondary	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	No
Secondary	Compliance	Assess whether self-reported adherence with the treatment (self-hypnosis or CDE) influenced degree of weight loss	one year	No
Secondary	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	No
Secondary	Degree of weight loss in obese versus overweight	Determine if starting BMI influenced degree of weight loss.	one year	No