OverweightNCT00709501
Disseminating Effective Habits for Long-Term Weight Loss
A study testing Disseminating Effective Habits for Long-term Weight Loss and Achieve Together website in people with Overweight and Obesity, run by Penn State University at 1 site in United States.
Trial summary
The purpose of the study is to determine whether using a web-based weight loss website can help overweight individuals lose weight. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Disseminating Effective Habits for Long-term Weight Loss and Achieve Together 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
- Jul 2009to Dec 2010
- 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
- Age 21-65
- BMI 27-40 kg/m2
- Fluently speaks and reads English
- Access to the Internet at home or at work
- Valid email address
- Access to a scale for weekly weigh-ins
Show all 9Show fewer
- Agree not to seek additional weight loss treatment
- Agree to come back regardless of amount of weight lost
- Participant in NCT00377208
Who cannot join
- Current, planned, or previous pregnancy within 12 months
- Planned or past weight loss surgery
- Recent weight loss of >= 15 lbs in the past 6 months
- History of:
- Myocardial infarction
- Stroke
Show all 14Show fewer
- Type 1 and Type 2 diabetes
- Unstable angina
- Congestive heart failure
- Inability to exercise due to severe arthritis or other musculoskeletal problems
- Cancer (except non-melanoma skin cancer)
- Evidence of severe cognitive impairment or major psychiatric illness
- Plans to move in the next 6 months
- Answering yes to any question on the Physical Activity Readiness Questionnaire (PAR-Q)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine General Clinical Research Center
Hershey, Pennsylvania, 17033
About this study
The purpose of the study is to determine whether using a web-based weight loss website can help overweight individuals lose weight.
Read the detailed description
Overweight and obesity are serious threats to public health. Over the last 20 years, the percentage of overweight and obese Americans, as well as the rate of diabetes, have grown tremendously (Cowie, Rust et al. 2006).
Few individuals are successful at long-term weight loss. Long-term weight loss is an elusive, yet sought after goal for many Americans (2000). Fewer than 5% of adults are successful in maintaining a 20 pound weight loss for at least 2 years (Klem, Wing et al. 1997). While medications can be effective, they produce only small amounts of weight loss, carry a significant cost and appear to be effective only while being taken (2000). Surgery is an effective option, though the procedure has tremendous costs and potential complications (2000). This points to the need for innovative and effective treatments that helps individuals over the longer-term.
Some, but not all, web-based treatments for weight loss have been shown to be effective. A recent study by Tate and colleagues showed that individuals who received counseling emails from a human or automated emails from a computer lost more weight than individuals who received neither(7.3 kg lost v. 4.9 kg and 2.6 kg, respectively) (Tate, Jackvony et al. 2006) (Tate, Jackvony et al. 2003). The feedback in the emails was based on diet and physical activity information that the individuals entered online. Dr. Harvey-Berino and colleagues has shown that social support delivered via the Internet can help weight loss efforts to the same degree as in person support (Harvey-Berino, Pintauro et al. 2004). Other studies have been mixed in their effects (Williamson, Walden et al. 2006) (Gold, Burke et al. 2007) (Wing, Tate et al. 2006), though there has generally been an effect from human feedback delivered via a computer. Other than the recent study by Tate and colleagues, no fully automated website has been effective at producing weight loss. It is our belief that fully automated systems are needed to meet the needs, in a cost-effective manner, of the 80 million overweight Americans who will need life-long help in losing weight and in maintaining their weight loss.
During an earlier phase of the study, 50 in-depth interviews were conducted with individuals who have been successful at losing weight and keeping it off. These individuals were asked specifically about which habits they use to maintain their weight loss, how these habits are implemented and how barriers to using these habits are overcome. These interviews were transcribed and the data entered into a website, to be used as part of the intervention to be tested in this clinical trial.
- Conditions
- Overweight, Obesity
- Being tested
- Disseminating Effective Habits for Long-term Weight Loss, Achieve Together website
- Keywords
- weight loss, obesity, overweight
- 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.
Disseminating Effective Habits for Long-term Weight LossBehavioural
Comparison of weight change among those participants in the weight loss intervention (immediate access to the weight loss website) and those participants in the control group (delayed access to the weight loss website).
Achieve Together websiteBehavioural
access to the Achieve Together website immediately (Arm 1) or delayed (Arm 2)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants in the intervention condition are encouraged to access the Achieve Together website at least once each week. During each login, the following activities will occur:
1. Users will enter their weight and height, how well their plan for a healthy weight has been going, and clarify their goal weight.
2. Users will answer questions about each habit they are using to lose weight
3. Users will receive automated feedback about each habit and will be encouraged to change or delete habits that are being used but not helpful, more consistently use habits that are helpful but not used being used and to continue to use habits that are helpful and being used consistently.
4. Users are encouraged to search for habits that have helped people of similar age and gender to themselves. Receives: Behavioral: Disseminating Effective Habits for Long-term Weight Loss; Behavioral: Achieve Together website |
| 2 | No intervention | Participants in the control condition will have to wait 12 weeks before accessing the Achieve Together website. These participants will be a given a log where they can document weekly weight measurements (this part did not happen). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Weight will be measured using a calibrated, digital scale
Measured: 3 months
Blood Pressure Control
Measured: 3-Months
Secondary outcomes (3)
Physical Activity, using the International Physical Activity Questionnaire
Results are still being analyzed
Measured: 3 months
Block 2005 FFQ for assessment of diet and physical activity
Measured: 3 Months
IWQOL-Lite, a validated, 31-item, self-report measure of obesity-specific
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 posted3 Jul 2008 (estimated)
- Study startJul 2009
- Primary completionFeb 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher N. Sciamanna, Penn State University
- Investigators
- Christopher N Sciamanna, M.D., MPH, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709501
- Sponsor's protocol ID
- 28160
- Status last verified
- Oct 2015
- First submitted
- 1 Jul 2008
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kraschnewski JL, Stuckey HL, Rovniak LS, Lehman EB, Reddy M, Poger JM, Kephart DK, Coups EJ, Sciamanna CN. Efficacy of a weight-loss website based on positive deviance. A randomized trial. Am J Prev Med. 2011 Dec;41(6):610-4. doi: 10.1016/j.amepre.2011.08.012.
PubMed 22099238
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disseminating Effective Habits for Long-Term Weight Loss
- ClinicalTrials.gov ID
- NCT00709501
- Acronym / sponsor ID
- 28160
- Conditions
- Overweight, Obesity
- Keywords
- weight loss, obesity, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Jul 2008 (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.
The purpose of the study is to determine whether using a web-based weight loss website can help overweight individuals lose weight.
Detailed description
Overweight and obesity are serious threats to public health. Over the last 20 years, the percentage of overweight and obese Americans, as well as the rate of diabetes, have grown tremendously (Cowie, Rust et al. 2006).
Few individuals are successful at long-term weight loss. Long-term weight loss is an elusive, yet sought after goal for many Americans (2000). Fewer than 5% of adults are successful in maintaining a 20 pound weight loss for at least 2 years (Klem, Wing et al. 1997). While medications can be effective, they produce only small amounts of weight loss, carry a significant cost and appear to be effective only while being taken (2000). Surgery is an effective option, though the procedure has tremendous costs and potential complications (2000). This points to the need for innovative and effective treatments that helps individuals over the longer-term.
Some, but not all, web-based treatments for weight loss have been shown to be effective. A recent study by Tate and colleagues showed that individuals who received counseling emails from a human or automated emails from a computer lost more weight than individuals who received neither(7.3 kg lost v. 4.9 kg and 2.6 kg, respectively) (Tate, Jackvony et al. 2006) (Tate, Jackvony et al. 2003). The feedback in the emails was based on diet and physical activity information that the individuals entered online. Dr. Harvey-Berino and colleagues has shown that social support delivered via the Internet can help weight loss efforts to the same degree as in person support (Harvey-Berino, Pintauro et al. 2004). Other studies have been mixed in their effects (Williamson, Walden et al. 2006) (Gold, Burke et al. 2007) (Wing, Tate et al. 2006), though there has generally been an effect from human feedback delivered via a computer. Other than the recent study by Tate and colleagues, no fully automated website has been effective at producing weight loss. It is our belief that fully automated systems are needed to meet the needs, in a cost-effective manner, of the 80 million overweight Americans who will need life-long help in losing weight and in maintaining their weight loss.
During an earlier phase of the study, 50 in-depth interviews were conducted with individuals who have been successful at losing weight and keeping it off. These individuals were asked specifically about which habits they use to maintain their weight loss, how these habits are implemented and how barriers to using these habits are overcome. These interviews were transcribed and the data entered into a website, to be used as part of the intervention to be tested in this clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Disseminating Effective Habits for Long-term Weight Loss, Behavioral: Achieve Together websiteParticipants in the intervention condition are encouraged to access the Achieve Together website at least once each week. During each login, the following activities will occur: 1. Users will enter their weight and height, how well their plan for a healthy weight has been going, and clarify their goal weight. 2. Users will answer questions about each habit they are using to lose weight 3. Users will receive automated feedback about each habit and will be encouraged to change or delete habits that are being used but not helpful, more consistently use habits that are helpful but not used being used and to continue to use habits that are helpful and being used consistently. 4. Users are encouraged to search for habits that have helped people of similar age and gender to themselves. |
| 2 | No intervention | –Participants in the control condition will have to wait 12 weeks before accessing the Achieve Together website. These participants will be a given a log where they can document weekly weight measurements (this part did not happen). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 21-65
- BMI 27-40 kg/m2
- Fluently speaks and reads English
- Access to the Internet at home or at work
- Valid email address
Key exclusion criteria (14 listed)
- Current, planned, or previous pregnancy within 12 months
- Planned or past weight loss surgery
- Recent weight loss of >= 15 lbs in the past 6 months
- History of:
- Evidence of severe cognitive impairment or major psychiatric illness
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 |
|---|---|---|
| Disseminating Effective Habits for Long-term Weight LossComparison of weight change among those participants in the weight loss intervention (immediate access to the weight loss website) and those participants in the control group (delayed access to the weight loss website). | Behavioural | 1 |
| Achieve Together websiteaccess to the Achieve Together website immediately (Arm 1) or delayed (Arm 2) | Behavioural | 1 |
Primary outcome
Body weight
Time frame: 3 months
Weight will be measured using a calibrated, digital scale
Blood Pressure Control
Time frame: 3-Months
3 secondary outcomes
Physical Activity, using the International Physical Activity Questionnaire
Time frame: 3 months
Block 2005 FFQ for assessment of diet and physical activity
Time frame: 3 Months
IWQOL-Lite, a validated, 31-item, self-report measure of obesity-specific
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 21 Oct 2015.
- Derived from this study: PubMed 22099238Kraschnewski JL, Stuckey HL, Rovniak LS, Lehman EB, Reddy M, Poger JM, Kephart DK, Coups EJ, Sciamanna CN. Efficacy of a weight-loss website based on positive deviance. A randomized trial. Am J Prev Med. 2011 Dec;41(6):610-4. doi: 10.1016/j.amepre.2011.08.012.
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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 N Sciamanna, M.D., MPH principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disseminating Effective Habits for Long-term Weight Loss and Achieve Together website in people with Overweight and Obesity, run by Penn State University 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 9 inclusion and 14 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 21 Oct 2015. 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?
Body weight (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00709501, which also lists 1 linked publication.
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 21 Oct 2015.