Skip to main content
OpenTrials
Completed

NCT Number: NCT02769585

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-hypnosis

Behavioral

Self-hypnosis

CDE training

Behavioral

standard CDE training for an obese diabetic

Primary outcomes

  1. Change in weight (BMI)

    Time frame: one year

    Comparison of subject's weight (BMI) from screening visit to last study visit.

Secondary outcomes

  1. Waist circumference

    Time frame: One year

    change in waist circumference from screening visit to last study date

  2. hemoglobin A1c

    Time frame: one year

    change in Hgb A1c from screening to last study visit

  3. fasting glucose

    Time frame: one year

    change in fasting glucose from screening visit to last study visit

  4. High versus low imagery

    Time frame: one year

    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.

  5. Compliance

    Time frame: one year

    Assess whether self-reported adherence with the treatment (self-hypnosis or CDE) influenced degree of weight loss

  6. Reproducibility of IPQ

    Time frame: one year

    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.

  7. Degree of weight loss in obese versus overweight

    Time frame: one year

    Determine if starting BMI influenced degree of weight loss.

Sponsors and collaborators

Lead sponsor

Levenson, David I., M.D.

Indiv

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 11, 2016
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.