OverweightWWONCT01888172
Weight Watchers Online
A study testing Weight Watchers Online Program, Philips ActiveLink and Eating and Activity Newsletter in people with Overweight and Obesity, run by The Miriam Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to conduct a randomized controlled trial to compare the weight losses produced by the Weight Watchers Online program (WWO) and WWO plus the Philips ActiveLink physical activity system, over a 1-year period, compared to a control group. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Weight Watchers Online Program, Philips ActiveLink and Eating and Activity Newsletter
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to Jun 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 27 and 40 kg/m2
- All ethnic groups will be recruited
- English speaking
- Have access to the Internet via a computer, and basic computer skills
Who cannot join
- Report health problems that make weight loss or unsupervised exercise unsafe or unreasonable
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
- Are currently pregnant or breastfeeding, or intend to become pregnant in the next 12 months
- Are planning to move outside of the state within the next 12 months
- Report any cognitive or physical limitations that preclude use of a personal computer
- Have participated in a study conducted by the WCDRC or UT in the past 2 years
Show all 12Show fewer
- Have followed a commercial weight-loss program within the previous 6 months or who are currently following a commercial weight loss program
- Weight loss of ≥ 5% of initial body weight in the last 6 months
- History of clinically diagnosed eating disorder excluding Binge Eating Disorder.
- Previous surgical procedure for weight loss
- Currently taking weight loss medication
- Treatment of cancer within the last 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Tennessee
Knoxville, Tennessee, 37996
Miriam Hospital Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903
About this study
The purpose of this study is to conduct a randomized controlled trial to compare the weight losses produced by the Weight Watchers Online program (WWO) and WWO plus the Philips ActiveLink physical activity system, over a 1-year period, compared to a control group.
- Conditions
- Overweight, Obesity
- Being tested
- Weight Watchers Online Program, Philips ActiveLink, Eating and Activity Newsletter
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Watchers Online ProgramBehavioural
Access to the Weight Watchers Online program available via the Internet on personal computers, tablet computers, and smartphones.
Philips ActiveLinkDevice
Provision of a key-chain sized physical activity monitor that interfaces with the Weight Watchers website to promote exercise and give feedback on progress towards exercise goals.
Eating and Activity NewsletterBehavioural
General information on healthy eating and physical activity habits and the medical consequences of overweight/obesity and weight loss.
| Study group | Role | What they receive |
|---|---|---|
| Weight Watchers Online | Experimental | Not described Receives: Behavioral: Weight Watchers Online Program |
| Weight Watchers Online + ActiveLink | Experimental | Not described Receives: Behavioral: Weight Watchers Online Program; Device: Philips ActiveLink |
| Internet Delivered Eating and Activity Program | Active comparator | Not described Receives: Behavioral: Eating and Activity Newsletter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight, measured in kilograms
Measured: 3, 6, 9, and 12 months after randomizaiton
Secondary outcomes (2)
Engagement with the electronic intervention system
The frequency with with participants interact with the Weight Watchers Online and control group websites.
Measured: 3, 6, 9, and 12 months after randomization
Blood pressure
Measured: 3, 6, 9, and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2015
- Study completionJun 2015
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.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- WW International Inc, University of Tennessee
- Responsible party
- Principal investigator, John Graham Thomas, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888172
- Sponsor's protocol ID
- WeightWatchersOnline
- Acronym
- WWO
- Status last verified
- Sep 2015
- First submitted
- 24 Jun 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Thomas JG, Raynor HA, Bond DS, Luke AK, Cardoso CC, Foster GD, Wing RR. Weight loss in Weight Watchers Online with and without an activity tracking device compared to control: A randomized trial. Obesity (Silver Spring). 2017 Jun;25(6):1014-1021. doi: 10.1002/oby.21846. Epub 2017 Apr 24.
PubMed 28437597
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Watchers Online
- ClinicalTrials.gov ID
- NCT01888172
- Acronym / sponsor ID
- WWO / WeightWatchersOnline
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- WW International Inc, University of Tennessee
- Study start
- May 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Jun 2013 (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 this study is to conduct a randomized controlled trial to compare the weight losses produced by the Weight Watchers Online program (WWO) and WWO plus the Philips ActiveLink physical activity system, over a 1-year period, compared to a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weight Watchers Online | Experimental | Behavioral: Weight Watchers Online Program |
| Weight Watchers Online + ActiveLink | Experimental | Behavioral: Weight Watchers Online Program, Device: Philips ActiveLink |
| Internet Delivered Eating and Activity Program | Active comparator | Behavioral: Eating and Activity Newsletter |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) between 27 and 40 kg/m2
- All ethnic groups will be recruited
- English speaking
- Have access to the Internet via a computer, and basic computer skills
Key exclusion criteria (12 listed)
- Report health problems that make weight loss or unsupervised exercise unsafe or unreasonable
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
- Are currently pregnant or breastfeeding, or intend to become pregnant in the next 12 months
- Are planning to move outside of the state within the next 12 months
- Report any cognitive or physical limitations that preclude use of a personal computer
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 |
|---|---|---|
| Weight Watchers Online ProgramAccess to the Weight Watchers Online program available via the Internet on personal computers, tablet computers, and smartphones. | Behavioural | Weight Watchers Online, Weight Watchers Online + ActiveLink |
| Philips ActiveLinkProvision of a key-chain sized physical activity monitor that interfaces with the Weight Watchers website to promote exercise and give feedback on progress towards exercise goals. | Device | Weight Watchers Online + ActiveLink |
| Eating and Activity NewsletterGeneral information on healthy eating and physical activity habits and the medical consequences of overweight/obesity and weight loss. | Behavioural | Internet Delivered Eating and Activity Program |
Primary outcome
Change in body weight, measured in kilograms
Time frame: 3, 6, 9, and 12 months after randomizaiton
2 secondary outcomes
Engagement with the electronic intervention system
Time frame: 3, 6, 9, and 12 months after randomization
Blood pressure
Time frame: 3, 6, 9, and 12 months after randomization
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 23 Sep 2015.
- Derived from this study: PubMed 28437597Thomas JG, Raynor HA, Bond DS, Luke AK, Cardoso CC, Foster GD, Wing RR. Weight loss in Weight Watchers Online with and without an activity tracking device compared to control: A randomized trial. Obesity (Silver Spring). 2017 Jun;25(6):1014-1021. doi: 10.1002/oby.21846. Epub 2017 Apr 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Watchers Online Program, Philips ActiveLink and Eating and Activity Newsletter in people with Overweight and Obesity, run by The Miriam Hospital at 2 sites 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 12 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 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in body weight, measured in kilograms (time frame: 3, 6, 9, and 12 months after randomizaiton). 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 NCT01888172, 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 23 Sep 2015.