ObesityPhase 2/3NCT00284167
Efficacy of a Web-based Tailored Weight Management Program
A Phase 2/3 study testing tailored web-based weight management intervention in people with Obesity, run by Robert Wood Johnson Foundation at 1 site in United States.
Trial summary
The primary objective of this study is to assess the benefit of using online, tailored behavioral weight management materials (Balance), in combination with nutritional materials (Balance and Nourish), in conjunction with a goal setting tool (Balance and Achieve), or a combination of all three (Balance, Nourish and… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- tailored web-based weight management intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,848 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jul 2006
- Phase
- Phase 2/3
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years of age
- Current KP or GHC member
- BMI greater than or equal to 30 or BMI greater than or equal to 25 and have one of the following chronic illnesses: diabetes, coronary artery disease, depression, or asthma, or arthritis.
- Agree to be contacted via computerized questionnaire at 3, 12 and 18 months post-enrollment
- Regular access to the Internet and a functioning e-mail address
Who cannot join
- Current use of pharmacologic, behavioral or surgical treatment for weight loss
- Currently pregnant or planning pregnancy
- Inability to read English.
- Presence of Congestive Heart Failure
- KP Ohio region members who participated in the original THeME study
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Care Management Institute
Walnut Creek, California, 94596
About this study
Official title: Efficacy of a Web-based Tailored Weight Management Program With and Without Tailored Nutrition and Goal Setting Support
The primary objective of this study is to assess the benefit of using online, tailored behavioral weight management materials (Balance), in combination with nutritional materials (Balance and Nourish), in conjunction with a goal setting tool (Balance and Achieve), or a combination of all three (Balance, Nourish and Achieve). This objective will be evaluated by measuring weight loss rates as reported by study participants at 3, 12, and 18 months post-enrollment. The hypothesis is that adding additional materials will increase the effect of the intervention over just using Balance alone.
Read the detailed description
This will be a randomized control, web-based trial for weight management with four treatment arms. Participants will be assigned to receive tailored materials from either: 1) the Balance program, 2) the Balance and Nourish programs, 3) the Balance and Achieve programs, or 4) the Balance, Nourish and Achieve programs. Participants will be recruited directly through their health care organization. In order to participate, participants must visit the website to confirm their eligibility, e.g. valid e-mail address. Those who wish to participate will provide consent on the Web, and then will be presented with an online questionnaire. These questions will provide baseline data for each participant and will be the basis for the tailoring of the Balance materials each participant will receive. Within 24 hours of submitting the completed questionnaire, participants will be informed by e-mail that their tailored Balance plan is available on the website. They will receive follow-up materials by e-mail during the six-week period after they enroll. Participants who have been assigned to additional programs will be sent e-mails with links to the relevant programs. At 3, 12 and 18 months, all participants will be assessed via an online survey. The assessment will include weight management parameters, psychosocial outcomes, and program utilization. This data will be self-reported.
STUDY POPULATION The study sample will be drawn from members of three integrated delivery systems: Kaiser Permanente Colorado (KPCO), Kaiser Permanente Ohio (KPOH), and Group Health Cooperative (GHC) of Puget Sound. In order to participate, participants must access and enroll in the study on the Web. A total of 1,848 participants will be enrolled within a six-month period, with approximately 450 participants in each treatment arm. By 18-month follow-up, we assume successful data collection from at least 65 percent of the enrollees, or 1200 participants, 300 in each treatment group. The study is open to those who meet the inclusion and exclusion criteria.
- Conditions
- Obesity
- Being tested
- tailored web-based weight management intervention
- Keywords
- tailored, web-based, weight management, obesity, efficacy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tailored web-based weight management interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to assess weight reduction at 3, 12, and 18 months post intervention.
Secondary outcomes (12)
• To assess psychosocial outcomes including motivation and self-efficacy.
• To assess the degree to which participants perceive their support materials have been tailored for them.
• To assess lifestyle changes including physical activity and nutrition
• To examine relative effectiveness of web-based programs given age, gender, preferred language, ethnicity, and utilization patterns.
• To examine percent of weight loss goal attainment.
• To examine participation rates by the BMI strata stated above.
• To assess the perceived helpfulness of the behavioral support materials with the participants' weight loss attempts.
• To assess the overall satisfaction with the programs.
• To assess participant satisfaction with Kaiser Permanente or GHC.
• To assess changes in self-reported health status.
• To assess changes in self-reported medical outpatient utilization.
• To assess self-reported work productivity (days missed from work or school).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startSep 2003
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 1,848 participants
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Investigators
- Kevin J Wildenhaus, Ph.D., Principal investigator, HealthMedia, Inc.Russ Glasgow, Ph.D., Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284167
- Sponsor's protocol ID
- 49147
- Status last verified
- Jul 2011
- First submitted
- 24 Jan 2006
- Last updated
- 27 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Web-based Tailored Weight Management Program With and Without Tailored Nutrition and Goal Setting Support
- ClinicalTrials.gov ID
- NCT00284167
- Acronym / sponsor ID
- 49147
- Conditions
- Obesity
- Keywords
- tailored, web-based, weight management, obesity, efficacy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,848 participants
- Lead sponsor
- Robert Wood Johnson FoundationUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- Sep 2003
- Study completion
- Jul 2006 (actual)
- First posted
- 31 Jan 2006 (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 primary objective of this study is to assess the benefit of using online, tailored behavioral weight management materials (Balance), in combination with nutritional materials (Balance and Nourish), in conjunction with a goal setting tool (Balance and Achieve), or a combination of all three (Balance, Nourish and Achieve). This objective will be evaluated by measuring weight loss rates as reported by study participants at 3, 12, and 18 months post-enrollment. The hypothesis is that adding additional materials will increase the effect of the intervention over just using Balance alone.
Detailed description
This will be a randomized control, web-based trial for weight management with four treatment arms. Participants will be assigned to receive tailored materials from either: 1) the Balance program, 2) the Balance and Nourish programs, 3) the Balance and Achieve programs, or 4) the Balance, Nourish and Achieve programs. Participants will be recruited directly through their health care organization. In order to participate, participants must visit the website to confirm their eligibility, e.g. valid e-mail address. Those who wish to participate will provide consent on the Web, and then will be presented with an online questionnaire. These questions will provide baseline data for each participant and will be the basis for the tailoring of the Balance materials each participant will receive. Within 24 hours of submitting the completed questionnaire, participants will be informed by e-mail that their tailored Balance plan is available on the website. They will receive follow-up materials by e-mail during the six-week period after they enroll. Participants who have been assigned to additional programs will be sent e-mails with links to the relevant programs. At 3, 12 and 18 months, all participants will be assessed via an online survey. The assessment will include weight management parameters, psychosocial outcomes, and program utilization. This data will be self-reported.
STUDY POPULATION The study sample will be drawn from members of three integrated delivery systems: Kaiser Permanente Colorado (KPCO), Kaiser Permanente Ohio (KPOH), and Group Health Cooperative (GHC) of Puget Sound. In order to participate, participants must access and enroll in the study on the Web. A total of 1,848 participants will be enrolled within a six-month period, with approximately 450 participants in each treatment arm. By 18-month follow-up, we assume successful data collection from at least 65 percent of the enrollees, or 1200 participants, 300 in each treatment group. The study is open to those who meet the inclusion and exclusion criteria.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-75 years of age
- Current KP or GHC member
- BMI greater than or equal to 30 or BMI greater than or equal to 25 and have one of the following chronic illnesses: diabetes, coronary artery disease, depression, or asthma, or arthritis.
- Agree to be contacted via computerized questionnaire at 3, 12 and 18 months post-enrollment
- Regular access to the Internet and a functioning e-mail address
Key exclusion criteria (5 listed)
- Current use of pharmacologic, behavioral or surgical treatment for weight loss
- Currently pregnant or planning pregnancy
- Inability to read English.
- Presence of Congestive Heart Failure
- KP Ohio region members who participated in the original THeME study
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 |
|---|---|---|
| tailored web-based weight management intervention | Behavioural | – |
Primary outcome
The primary objective of this study is to assess weight reduction at 3, 12, and 18 months post intervention.
12 secondary outcomes
• To assess psychosocial outcomes including motivation and self-efficacy.
• To assess the degree to which participants perceive their support materials have been tailored for them.
• To assess lifestyle changes including physical activity and nutrition
• To examine relative effectiveness of web-based programs given age, gender, preferred language, ethnicity, and utilization patterns.
• To examine percent of weight loss goal attainment.
• To examine participation rates by the BMI strata stated above.
• To assess the perceived helpfulness of the behavioral support materials with the participants' weight loss attempts.
• To assess the overall satisfaction with the programs.
• To assess participant satisfaction with Kaiser Permanente or GHC.
• To assess changes in self-reported health status.
• To assess changes in self-reported medical outpatient utilization.
• To assess self-reported work productivity (days missed from work or school).
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 27 Jul 2011.
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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.
Kevin J Wildenhaus, Ph.D. principal investigator
HealthMedia, Inc.
Russ Glasgow, Ph.D. principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing tailored web-based weight management intervention in people with Obesity, run by Robert Wood Johnson Foundation 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 5 inclusion and 5 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 27 Jul 2011. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary objective of this study is to assess weight reduction at 3, 12, and 18 months post intervention.. 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 27 Jul 2011; AzTrials last refreshed its copy on 30 Oct 2026.