Text Size

Journaling and Weight Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of California, Davis.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00884195
First received: April 17, 2009
Last updated: May 25, 2011
Last verified: May 2011
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Journaling and Weight Loss

Resource links provided by NLM:

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: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Gratitude Journaling
 Behavioral: Gratitude Journaling
Participants will be asked to write down 5 things every day for which they are grateful.
Placebo Comparator: 2
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

Locations
United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95817
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: CT Kappagoda, University of California Davis
ClinicalTrials.gov Identifier: NCT00884195     History of Changes
Other Study ID Numbers: 200816667-1
Study First Received: April 17, 2009
Last Updated: May 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Obesity

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on June 17, 2013