Journaling and Weight Loss

Obesity Clinical Trial

Official title:

Journaling and Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884195
• Other study ID #: 200816667
• Status: Completed
• Phase: Phase 1
• First received: April 17, 2009
• Last updated: July 6, 2017
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study to evaluate the effect of keeping a 'gratitude journal' on the outcome of a weight loss program. All the subjects will be enrolled in the Lifesteps weight management program. The experimental group will maintain a gratitude journal and the control group will maintain a 'neutral' journal.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Gratitude Journaling
Participants will be asked to write down 5 things every day for which they are grateful.
• Neutral Journaling
Participants will be asked to write down 5 things every day that they noticed about being involved in a weight loss program.

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		3 months
Secondary	Quality of Life		3 months
Secondary	Class attendance		3 months