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Journaling and Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gratitude Journaling
Neutral Journaling
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Davis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Gratitude Journaling

Neutral Journaling

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Quality of Life
Class attendance

Full Information

First Posted
April 17, 2009
Last Updated
July 6, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00884195
Brief Title
Journaling and Weight Loss
Official Title
Journaling and Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Gratitude Journaling
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Neutral Journaling
Intervention Type
Behavioral
Intervention Name(s)
Gratitude Journaling
Intervention Description
Participants will be asked to write down 5 things every day for which they are grateful.
Intervention Type
Behavioral
Intervention Name(s)
Neutral Journaling
Intervention Description
Participants will be asked to write down 5 things every day that they noticed about being involved in a weight loss program.
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
3 months
Title
Class attendance
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CT Kappagoda, MD, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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