Journaling and Weight Loss - Full Text View

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00884195

Purpose

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.

Condition	Intervention	Phase
Obesity	Behavioral: Gratitude Journaling Behavioral: Neutral Journaling	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Journaling and Weight Loss

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

Weight loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Class attendance [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	January 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Gratitude Journaling	Behavioral: Gratitude Journaling Participants will be asked to write down 5 things every day for which they are grateful.
2: Placebo Comparator Neutral Journaling	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.

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884195

Contacts

Contact: Sharon Myers, BSN, MS	916-734-8407	sharon.myers@ucdmc.ucdavis.edu
Contact: Debbie Lucus, MS, RD	916-734-6473	debbie.lucus@ucdmc.ucdavis.edu

Locations

United States, California
University of California, Davis, Medical Center	Recruiting
Sacramento, California, United States, 95817
Principal Investigator: CT Kappagoda, MD, PhD

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

CT Kappagoda, MD, PhD

University of California, Davis

More Information

No publications provided

Responsible Party:	University of California Davis ( CT Kappagoda )
Study ID Numbers:	200816667-1
Study First Received:	April 17, 2009
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00884195 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

Obesity

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on August 24, 2009