Effects of Journaling on Weight Loss
Primary Purpose
Overweight, Obese
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tracking
Journaling
Website
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Weight loss, Web-based, Journaling, Body Mass Index between 27 and 45
Eligibility Criteria
Inclusion Criteria:
- 21 to 65 years old
- Body mass index between 27 and 45
- E-mail and Internet access
- Able to read, write, and understand English
Exclusion Criteria:
- Weight loss of more than 5% of current body weight in previous 6 months
- Participated in weight loss research in previous 6 months
- Current use of weight loss medication or program
- History of or scheduled weight loss surgery
- Heart, liver, or kidney failure
- Been told by doctor of heart trouble
- Frequent pains in heart and chest
- Often feel faint or have spells of severe dizziness
- Bone or joint problem that has been or might be aggravated by exercise
- Physical reason for not following activity program
- History of sever cognitive impairment or major psychiatric illness
- Pregnant in previous 6 months, currently or planning to become pregnant in next 3 months
- Moving in next 6 months
Sites / Locations
- Penn State Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tracking + Journaling + Website
Enhanced Usual Care
Arm Description
In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.
Participants receive standard care
Outcomes
Primary Outcome Measures
Weight
Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.
Secondary Outcome Measures
Blood Pressure
Blood pressure will be measured by study staff using an automatic blood pressure monitor.
Height
Height will be measured using a portable stadiometer.
Full Information
NCT ID
NCT01660685
First Posted
August 1, 2012
Last Updated
January 31, 2013
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01660685
Brief Title
Effects of Journaling on Weight Loss
Official Title
Effects of Journaling on Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized controlled trial with enhanced usual care treatment control. The aim is to determine the effects of journaling and use of resource website on weight loss. There will be two groups of 55 participants each. The intervention condition will be asked to record daily weight, physical activity steps taken and pre-portioned food items and to complete two daily journaling activities. Participants will also receive weekly tracing data, a weekly blog from the principal investigator and have access to a weight control website. The control group will not have access to the tracking, journaling or website for three months. Investigators hypothesize that a website paired with tracking and journaling will be more effective in helping participants lose weight.
Detailed Description
Participants will call study line given on recruitment materials and be screened over the phone.
Baseline visit:
Individuals who meet the screening criteria will be invited to a one-hour training session about the website and diet plan book. During the training, a coordinator will review the consent form with the participants and ask if they have any questions. The coordinator will take consented individuals' height, weight and blood pressure measurements. Participants will be given a pedometer to use during physical activities and a meal replacement book to use as a resource.
After baseline visit:
All participants will complete surveys online (Demographics, Three-Factor Eating Questionnaire, Motivation, Weight Loss Habits, Medication log, International Physical Activity Questionnaire) and be randomized into one of two groups. The intervention group will be asked to record their weight, physical activity steps, pre-portioned food items and journal entries on a daily basis. The control group will be sent an email informing them they will have access to the tracking, journals and website in three months.
Intervention Group:
Participants will receive daily emails with links to record their weight, physical activity steps and pre-portioned food items; participants will also complete a journaling response to two writing prompts. The emails will contain links to the website to be used as a resource. Every week, participants will enter whether they have an appointment with primary care provider in the next week. Participants will also receive weekly blogs from the principal investigator; participants can opt out of receiving the blog emails at any time. Coordinators will review the database weekly. If a participant has lost ten pounds, they will be emailed to call their doctor since weight loss can affect blood pressure and medication needs. If a participant has an upcoming primary care provider appointment, they will be emailed to print out their tracking graphs (weight, steps taken, meal replacements). Coordinators will also monitor journal responses; coordinators will contact participants who wrote useful entries to ask if the participant's responses can be shared with other participants. Shared posts will be anonymous; only the age of the individual will be given.
Month one and two visits:
Participants from both groups will be asked to come to Hershey Medical Center to have their height, weight and blood pressure measured.
Month three visit:
Participants from both groups will be asked to come to Hershey Medical Center to have their height, weight and blood pressure measured. Prior to their visit, participants will be asked to complete a series of surveys online (Three-Factor Eating Questionnaire, Motivation, Weight Loss Habits, Medication log, International Physical Activity Questionnaire, Satisfaction). Participants in the control group will be given a booklet containing the writing prompts, tracking and website address to complete on their own if they so choose.
Participants will be asked if they would like to come back for an optional video interview. The interview will consist of six questions about their experience with the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese
Keywords
Weight loss, Web-based, Journaling, Body Mass Index between 27 and 45
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tracking + Journaling + Website
Arm Type
Experimental
Arm Description
In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
Participants receive standard care
Intervention Type
Behavioral
Intervention Name(s)
Tracking
Intervention Description
Participants will record their daily weight, physical activity steps and meal replacements online
Intervention Type
Behavioral
Intervention Name(s)
Journaling
Intervention Description
Participants will journal to two online writing prompts: one on positive focus and one on goal setting
Intervention Type
Behavioral
Intervention Name(s)
Website
Intervention Description
Participants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
Participants will receive standard care of monthly height, weight and blood pressure measurements. Participants will also receive a pedometer and a diet plan book on pre-portioned items.
Primary Outcome Measure Information:
Title
Weight
Description
Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Blood pressure will be measured by study staff using an automatic blood pressure monitor.
Time Frame
3 months
Title
Height
Description
Height will be measured using a portable stadiometer.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Sociodemographics and tobacco use
Description
Age, gender, race, ethnicity, education, smoking status and other demographics will be measured by self-report
Time Frame
3 months
Title
Three-factor Eating Questionnaire
Description
Questionnaire asks participants about how their dietary restraint in specific circumstances
Time Frame
3 months
Title
Motivation
Description
Questionnaire asks participants to gauge their motivation to lose weight.
Time Frame
3 months
Title
Weight Loss Habits
Description
Questionnaire asks participants how often they use specific habits to lose weight
Time Frame
3 months
Title
Blood Pressure Medication
Description
Blood pressure medication names, doses and frequency measured by self-report
Time Frame
3 months
Title
International Physical Activity Questionnaire
Description
Questionnaire asks participants to estimate the frequency and duration of specific physical activities
Time Frame
3 months
Title
Satisfaction Survey
Description
Questionnaire asks participants about their satisfaction with specific aspects of the study
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
21 to 65 years old
Body mass index between 27 and 45
E-mail and Internet access
Able to read, write, and understand English
Exclusion Criteria:
Weight loss of more than 5% of current body weight in previous 6 months
Participated in weight loss research in previous 6 months
Current use of weight loss medication or program
History of or scheduled weight loss surgery
Heart, liver, or kidney failure
Been told by doctor of heart trouble
Frequent pains in heart and chest
Often feel faint or have spells of severe dizziness
Bone or joint problem that has been or might be aggravated by exercise
Physical reason for not following activity program
History of sever cognitive impairment or major psychiatric illness
Pregnant in previous 6 months, currently or planning to become pregnant in next 3 months
Moving in next 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Sciamanna, MD, MPH
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Journaling on Weight Loss
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