OverweightNCT01660685
Effects of Journaling on Weight Loss
A study testing Tracking, Journaling and Website in people with Overweight and Obese, run by Milton S. Hershey Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- Tracking, Journaling and Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 to 65 years old
- Body mass index between 27 and 45
- E-mail and Internet access
- Able to read, write, and understand English
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the 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
- Overweight, Obese
- Being tested
- Tracking, Journaling, Website, Enhanced Usual Care
- Keywords
- Weight loss, Web-based, Journaling, Body Mass Index between 27 and 45
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrackingBehavioural
Participants will record their daily weight, physical activity steps and meal replacements online
JournalingBehavioural
Participants will journal to two online writing prompts: one on positive focus and one on goal setting
WebsiteBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tracking + Journaling + Website | Experimental | In addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries. Receives: Behavioral: Tracking; Behavioral: Journaling; Behavioral: Website; Behavioral: Enhanced Usual Care |
| Enhanced Usual Care | Active comparator | Participants receive standard care Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.
Measured: 3 months
Secondary outcomes (2)
Blood Pressure
Blood pressure will be measured by study staff using an automatic blood pressure monitor.
Measured: 3 months
Height
Height will be measured using a portable stadiometer.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
- Investigators
- Christopher Sciamanna, MD, MPH, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660685
- Sponsor's protocol ID
- 39952EP
- Status last verified
- Jan 2013
- First submitted
- 1 Aug 2012
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Journaling on Weight Loss
- ClinicalTrials.gov ID
- NCT01660685
- Acronym / sponsor ID
- 39952EP
- Conditions
- Overweight, Obese
- Keywords
- Weight loss, Web-based, Journaling, Body Mass Index between 27 and 45
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tracking + Journaling + Website | Experimental | Behavioral: Tracking, Behavioral: Journaling, Behavioral: Website, Behavioral: Enhanced Usual CareIn addition to standard care, participants will complete daily tracking and journaling and receive weekly feedback based on their individual entries. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareParticipants receive standard care |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 21 to 65 years old
- Body mass index between 27 and 45
- E-mail and Internet access
- Able to read, write, and understand English
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrackingParticipants will record their daily weight, physical activity steps and meal replacements online | Behavioural | Tracking + Journaling + Website |
| JournalingParticipants will journal to two online writing prompts: one on positive focus and one on goal setting | Behavioural | Tracking + Journaling + Website |
| WebsiteParticipants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants. | Behavioural | Tracking + Journaling + Website |
| Enhanced 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. | Behavioural | Enhanced Usual Care, Tracking + Journaling + Website |
Primary outcome
Weight
Time frame: 3 months
Weight will be measured by study staff using a Tanita BWB 800S Digital Scale.
2 secondary outcomes
Blood Pressure
Time frame: 3 months
Height
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Sciamanna, MD, MPH principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracking, Journaling and Website in people with Overweight and Obese, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.