ObesityNCT00200304
Evaluation of a SlimFast Internet Behavioral Weight Loss Program
A study testing Internet weight loss with SlimFast and human counseling, Internet weight loss with SlimFast and computer counseling and Internet weight loss program with SlimFast in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The Internet has been used effectively in behavioral weight loss programs. Most of these programs have involved a therapist who provides email counseling. The purpose of this study was to determine whether a computer-assisted weight loss program could be developed (that would use pre-programmed computer generated… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Internet weight loss with SlimFast and human counseling, Internet weight loss with SlimFast and computer counseling and Internet weight loss program with SlimFast
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Jan 2003
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight or obese
Who cannot join
- heart disease
- stroke
- cancer
- diabetes
- orthopedic problems
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of a SlimFast Internet Behavioral Weight Loss Program
The Internet has been used effectively in behavioral weight loss programs. Most of these programs have involved a therapist who provides email counseling. The purpose of this study was to determine whether a computer-assisted weight loss program could be developed (that would use pre-programmed computer generated messages rather than human generated messages) and whether this program would be as effective as the therapist-assisted weight loss program.
Read the detailed description
Specific Aims Over 50% of Americans are overweight. These individuals are at increased risk of morbidity and mortality. Weight losses of 5-10% of body weight have been shown to lower these risks. The majority of individuals who lose weight do so on their own, without the help of formal programs. Developing ways to improve weight loss in such individuals is a major public health challenge. We believe that the Internet holds tremendous promise for reaching large numbers of overweight individuals and assisting them in their weight loss efforts. Our previous research has shown that a structured behavioral weight loss program offered via the Internet, with regular feedback from a therapist, can produce average weight losses of 9 lbs. at 6 months. The purpose of this project is to compare the weight losses achieved at 6 months using 3 different types of Internet programs, all of which are used in combination with SlimFast as the dietary component.Subject PopulationTwo hundred twenty-five overweight individuals will be recruited, aged 20-65 with a BMI of 27-40 who want to lose weight using SlimFast. Participants must be willing to attend an initial orientation and weigh-in session and follow-up weigh-in sessions and agree that they will not begin a second weight loss program within the next 12 months. Interested participants will be required to have access to a computer with Internet connection from their home or their workplace.Methods/DesignParticipants will be randomly assigned to one of three conditions: 1) SlimFast + Current SlimFast Website; 2) SlimFast + Current SlimFast Website + Computer-Generated E-mail feedback; or 3) SlimFast + Current SlimFast Website + Therapist-Assisted E-mail feedback. All 3 groups will be placed on a calorie-restricted diet (1200-1500 kcal/day) that utilizes SlimFast for 2 meals per day and a healthy evening meal. They will be encouraged to increase their exercise to 1000 kcal/week based on walking. Group 1 will receive all other input from the SlimFast website. Group 2 will receive weekly computer-generated feedback based on diet, physical activity and weight loss information. Group 3 will receive weekly e-mail messages from a trained therapist that will provide feedback based on diet, physical activity and weight loss information.Data AnalysisAll participants will be weighed at baseline, 3 months, and 6 months to document the weight changes they experience. The primary analysis will compare weight change from baseline to 6 months for the 3 conditions. An intent-to-treat analysis will be used, where dropouts are considered to have regained back to baseline weight. Secondary analyses will examine baseline predictors of weight loss and the association between use of the various Internet components and outcome.
- Conditions
- Obesity
- Being tested
- Internet weight loss with SlimFast and human counseling, Internet weight loss with SlimFast and computer counseling, Internet weight loss program with SlimFast
- Keywords
- Obesity, Weight loss, Internet
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet weight loss with SlimFast and human counselingBehavioural
Internet weight loss with SlimFast and computer counselingBehavioural
Internet weight loss program with SlimFastBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss at 6 months
Secondary outcomes (1)
Frequency of use of the Internet website
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2001
- Primary completionJan 2003
- Study completionJan 2003
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 ObesityStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Single blind
- Enrolment
- 225 participants
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Rena R Wing, Ph.D., Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200304
- Sponsor's protocol ID
- 2083-00
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 24 Apr 2013
- Results posted
- No
Publications
Tate DF, Jackvony EH, Wing RR. A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Arch Intern Med. 2006 Aug 14-28;166(15):1620-5. doi: 10.1001/archinte.166.15.1620.
PubMed 16908795
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a SlimFast Internet Behavioral Weight Loss Program
- ClinicalTrials.gov ID
- NCT00200304
- Acronym / sponsor ID
- 2083-00
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss, Internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 20 Sep 2005 (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 Internet has been used effectively in behavioral weight loss programs. Most of these programs have involved a therapist who provides email counseling. The purpose of this study was to determine whether a computer-assisted weight loss program could be developed (that would use pre-programmed computer generated messages rather than human generated messages) and whether this program would be as effective as the therapist-assisted weight loss program.
Detailed description
Specific Aims Over 50% of Americans are overweight. These individuals are at increased risk of morbidity and mortality. Weight losses of 5-10% of body weight have been shown to lower these risks. The majority of individuals who lose weight do so on their own, without the help of formal programs. Developing ways to improve weight loss in such individuals is a major public health challenge. We believe that the Internet holds tremendous promise for reaching large numbers of overweight individuals and assisting them in their weight loss efforts. Our previous research has shown that a structured behavioral weight loss program offered via the Internet, with regular feedback from a therapist, can produce average weight losses of 9 lbs. at 6 months. The purpose of this project is to compare the weight losses achieved at 6 months using 3 different types of Internet programs, all of which are used in combination with SlimFast as the dietary component.Subject PopulationTwo hundred twenty-five overweight individuals will be recruited, aged 20-65 with a BMI of 27-40 who want to lose weight using SlimFast. Participants must be willing to attend an initial orientation and weigh-in session and follow-up weigh-in sessions and agree that they will not begin a second weight loss program within the next 12 months. Interested participants will be required to have access to a computer with Internet connection from their home or their workplace.Methods/DesignParticipants will be randomly assigned to one of three conditions: 1) SlimFast + Current SlimFast Website; 2) SlimFast + Current SlimFast Website + Computer-Generated E-mail feedback; or 3) SlimFast + Current SlimFast Website + Therapist-Assisted E-mail feedback. All 3 groups will be placed on a calorie-restricted diet (1200-1500 kcal/day) that utilizes SlimFast for 2 meals per day and a healthy evening meal. They will be encouraged to increase their exercise to 1000 kcal/week based on walking. Group 1 will receive all other input from the SlimFast website. Group 2 will receive weekly computer-generated feedback based on diet, physical activity and weight loss information. Group 3 will receive weekly e-mail messages from a trained therapist that will provide feedback based on diet, physical activity and weight loss information.Data AnalysisAll participants will be weighed at baseline, 3 months, and 6 months to document the weight changes they experience. The primary analysis will compare weight change from baseline to 6 months for the 3 conditions. An intent-to-treat analysis will be used, where dropouts are considered to have regained back to baseline weight. Secondary analyses will examine baseline predictors of weight loss and the association between use of the various Internet components and outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Overweight or obese
Key exclusion criteria (6 listed)
- heart disease
- stroke
- cancer
- diabetes
- orthopedic problems
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 |
|---|---|---|
| Internet weight loss with SlimFast and human counseling | Behavioural | – |
| Internet weight loss with SlimFast and computer counseling | Behavioural | – |
| Internet weight loss program with SlimFast | Behavioural | – |
Primary outcome
Weight loss at 6 months
1 secondary outcome
Frequency of use of the Internet website
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 24 Apr 2013.
- Results publication: PubMed 16908795Tate DF, Jackvony EH, Wing RR. A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Arch Intern Med. 2006 Aug 14-28;166(15):1620-5. doi: 10.1001/archinte.166.15.1620.
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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.
Rena R Wing, Ph.D. principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet weight loss with SlimFast and human counseling, Internet weight loss with SlimFast and computer counseling and Internet weight loss program with SlimFast in people with Obesity, run by The Miriam Hospital 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 1 inclusion and 6 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 24 Apr 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 loss at 6 months. 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 NCT00200304, 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 24 Apr 2013.