Efficacy of Self-hypnosis for Weight Loss in Type 2 Diabetics
1 other identifier
interventional
74
0 countries
N/A
Brief Summary
Randomized study evaluating self-hypnosis versus certified diabetes educator training for weight loss in type 2 diabetics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jul 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 8, 2016
CompletedFirst Posted
Study publicly available on registry
May 11, 2016
CompletedMay 13, 2016
May 1, 2016
1.8 years
May 8, 2016
May 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in weight (BMI)
Comparison of subject's weight (BMI) from screening visit to last study visit.
one year
Secondary Outcomes (7)
Waist circumference
One year
hemoglobin A1c
one year
fasting glucose
one year
High versus low imagery
one year
Compliance
one year
- +2 more secondary outcomes
Study Arms (2)
Self-hypnosis
EXPERIMENTALSubjects 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.
CDE training
ACTIVE COMPARATORSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Type 2 Diabetes
- BMI greater than 25
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David I Levenson, MD
East Coast Medical Associates
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
May 8, 2016
First Posted
May 11, 2016
Study Start
July 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 13, 2016
Record last verified: 2016-05