Journaling and Weight Loss

NCT ID: NCT00884195

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-12-31

Brief 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.

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

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Gratitude Journaling

Group Type: EXPERIMENTAL

Gratitude Journaling

Intervention Type: BEHAVIORAL

Participants will be asked to write down 5 things every day for which they are grateful.

2

Neutral Journaling

Group Type: PLACEBO_COMPARATOR

Neutral Journaling

Intervention Type: BEHAVIORAL

Participants will be asked to write down 5 things every day that they noticed about being involved in a weight loss program.

Interventions

Gratitude Journaling

Participants will be asked to write down 5 things every day for which they are grateful.

Intervention Type: BEHAVIORAL

Neutral Journaling

Participants will be asked to write down 5 things every day that they noticed about being involved in a weight loss program.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CT Kappagoda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis Medical Center

Sacramento, California, United States

Countries

United States

Other Identifiers

200816667

Identifier Type: -

Identifier Source: org_study_id