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

NCT ID: NCT02769585

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-04-30

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.

Conditions

Obesity; Diabetes Mellitus, Type 2; Weight Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Self-hypnosis

Intervention Type: BEHAVIORAL

Self-hypnosis

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.

Group Type: ACTIVE_COMPARATOR

CDE training

Intervention Type: BEHAVIORAL

standard CDE training for an obese diabetic

Interventions

Self-hypnosis

Self-hypnosis

Intervention Type: BEHAVIORAL

CDE training

standard CDE training for an obese diabetic

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Levenson, David I., M.D.

INDIV

Sponsor Role: lead

Responsible Party

David I. Levenson, MD

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David I Levenson, MD

Role: PRINCIPAL_INVESTIGATOR

East Coast Medical Associates

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id