Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2012-08-31
2013-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tracking + Journaling + Website
In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries.
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.
Enhanced Usual Care
Participants receive standard care
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Body mass index between 27 and 45
* E-mail and Internet access
* Able to read, write, and understand English
Exclusion Criteria
* 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
21 Years
65 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Christopher Sciamanna, MD, MPH
Chief, Division of General Internal Medicine
Principal Investigators
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Christopher Sciamanna, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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Other Identifiers
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39952EP
Identifier Type: -
Identifier Source: org_study_id
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