Clinical Trials Directory

Trials / Completed

CompletedNCT01660685

Effects of Journaling on Weight Loss

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Milton S. Hershey Medical Center · Academic / Other
Sex
All
Age
21 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTrackingParticipants will record their daily weight, physical activity steps and meal replacements online
BEHAVIORALJournalingParticipants will journal to two online writing prompts: one on positive focus and one on goal setting
BEHAVIORALWebsiteParticipants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants.
BEHAVIORALEnhanced Usual CareParticipants 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.

Timeline

Start date
2012-08-01
Primary completion
2013-01-01
Completion
2013-01-01
First posted
2012-08-09
Last updated
2013-02-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01660685. Inclusion in this directory is not an endorsement.

Effects of Journaling on Weight Loss (NCT01660685) · Clinical Trials Directory