- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00884195
Journaling and Weight Loss
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects who are referred to the Preventive Cardiology Program for weight management will be enrolled in the study after obtaining informed consent.
Subjects are enrolled into the program in groups of 10 to 12 every 6 weeks. Alternate groups will be will assigned to the two types of journaling. Each group will be given specific instructions related to the form of journaling assigned. These instructions will be in addition to the usual care prescribed in the Lifesteps® program. In the intervention group, patients will be introduced to gratitude journaling at the beginning of the 12 week class series and asked to journal each day. They will turn in their gratitude journal weekly. At the beginning of each weekly class, five minutes will be spent discussing the journaling.
The control groups will not receive the information on gratitude journaling, but instead will be asked to complete a neutral journal in which they will journal in a general manner regarding their experiences participating in the Lifesteps® weight management program. These will also be collected weekly. At the beginning of class, five minutes will be spent discussing the journaling.
There will be one consent form for the two groups. The instruction (either gratitude journaling or neutral journaling) that will be given to the subjects will reflect the group to which they have been randomized. Both types of journals will be reviewed initially, at mid-point and final by the psychologist (Robert Emmons) to verify the quality of reporting.
Routine tests- Weekly weights
Study Tests:
Pre/post depression: Beck Depression Inventory II; Pre/post Locus of Control: Multidimensional Health Locus of Control Scale; Pre/post SF 36 Quality of Life Questionnaire; Pre/post Gratitude Questionnaire
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- University of California, Davis Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI>25
- >18 years of age
Exclusion Criteria:
- Severe psychiatric diagnosis which in the opinion of the PI would compromise participation in the study.
- Addiction to alcohol and drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Gratitude Journaling
|
Participants will be asked to write down 5 things every day for which they are grateful.
|
|
Placebo Comparator: 2
Neutral Journaling
|
Participants will be asked to write down 5 things every day that they noticed about being involved in a weight loss program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weight loss
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of Life
Time Frame: 3 months
|
3 months
|
|
Class attendance
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: CT Kappagoda, MD, PhD, University of California, Davis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200816667
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