Effects of Journaling on Weight Loss

Overweight Clinical Trial

Official title:

Effects of Journaling on Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660685
• Other study ID #: 39952EP
• Status: Completed
• Phase: N/A
• First received: August 1, 2012
• Last updated: January 31, 2013
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obese
• Overweight
• Weight Loss

Intervention

Behavioral:
• Tracking
Participants will record their daily weight, physical activity steps and meal replacements online
• Journaling
Participants will journal to two online writing prompts: one on positive focus and one on goal setting
• Website
Participants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants.
• Enhanced Usual Care
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.

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographics and tobacco use	Age, gender, race, ethnicity, education, smoking status and other demographics will be measured by self-report	3 months	No
Other	Three-factor Eating Questionnaire	Questionnaire asks participants about how their dietary restraint in specific circumstances	3 months	No
Other	Motivation	Questionnaire asks participants to gauge their motivation to lose weight.	3 months	No
Other	Weight Loss Habits	Questionnaire asks participants how often they use specific habits to lose weight	3 months	No
Other	Blood Pressure Medication	Blood pressure medication names, doses and frequency measured by self-report	3 months	No
Other	International Physical Activity Questionnaire	Questionnaire asks participants to estimate the frequency and duration of specific physical activities	3 months	No
Other	Satisfaction Survey	Questionnaire asks participants about their satisfaction with specific aspects of the study	3 months	No
Primary	Weight	Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.	3 months	No
Secondary	Blood Pressure	Blood pressure will be measured by study staff using an automatic blood pressure monitor.	3 months	No
Secondary	Height	Height will be measured using a portable stadiometer.	3 months	No