An interventional study of Tracking and Journaling in Overweight and Obese, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-02-04.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Treatment
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.
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 100 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.
Behavioral: Tracking · Behavioral: Journaling · Behavioral: Website · Behavioral: Enhanced Usual Care
Participants receive standard care
Behavioral: Enhanced Usual Care
Participants will record their daily weight, physical activity steps and meal replacements online
Participants will journal to two online writing prompts: one on positive focus and one on goal setting
Participants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants.
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.
Weight
Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.
Time frame: 3 months
Blood Pressure
Blood pressure will be measured by study staff using an automatic blood pressure monitor.
Time frame: 3 months
Height
Height will be measured using a portable stadiometer.
Time frame: 3 months
Sociodemographics and tobacco use
Age, gender, race, ethnicity, education, smoking status and other demographics will be measured by self-report
Time frame: 3 months
Three-factor Eating Questionnaire
Questionnaire asks participants about how their dietary restraint in specific circumstances
Time frame: 3 months
Motivation
Questionnaire asks participants to gauge their motivation to lose weight.
Time frame: 3 months
Weight Loss Habits
Questionnaire asks participants how often they use specific habits to lose weight
Time frame: 3 months
Blood Pressure Medication
Blood pressure medication names, doses and frequency measured by self-report
Time frame: 3 months
International Physical Activity Questionnaire
Questionnaire asks participants to estimate the frequency and duration of specific physical activities
Time frame: 3 months
Satisfaction Survey
Questionnaire asks participants about their satisfaction with specific aspects of the study
Time frame: 3 months
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Milton S. Hershey Medical Center