ObesityPhase 2/3OCELOT-PCNCT01044147
Online Counseling to Enable Lifestyle-focused Obesity Treatment in Primary Care
A Phase 2/3 study testing VLM-S, VLM-M and OGR in people with Obesity, run by University of Pittsburgh at 1 site in United States.
Trial summary
With over half of the US population currently overweight and 31% of adults now obese, the primary care setting may represent an important source of weight-loss support, in the interest of cardiovascular prevention. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- VLM-S, VLM-M and OGR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 2012
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese (BMI > 30kg/meters squared)
- Age 21-75
- Receives primary care at a participating primary care clinic in the Pittsburgh, PA area
Who cannot join
- Primary care physician determination that moderate physical activity is not safe or appropriate for the patient
- Pregnancy
- Planned pregnancy in the next 2 years
- Current breast-feeding
- Bariatric surgery in the past 2 years
- Planned bariatric surgery in the next 2 years
Show all 15Show fewer
- Edematous state that interferes with body weight assessment
- Health condition that is likely to influence body weight
- Heart attack within the past 3 months
- Regular use of prescription medication that is likely to influence body weight
- participation during the past year in either of the pilot programs for this study
- perceived lack of basic computer or Internet skills
- Inability to learn adequately from English language audio-recorded materials
- Lack of access to a scale
- Inability to attend an Orientation session
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
With over half of the US population currently overweight and 31% of adults now obese, the primary care setting may represent an important source of weight-loss support, in the interest of cardiovascular prevention. Yet, although the US Preventive Services task force recommends that physicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults, the recommendation has not been widely implemented. The Internet may help overcome many of the barriers that have prevented intensive obesity counseling in the clinical setting. The aim of this study is to examine whether Internet-based interventions for developing healthier lifestyles can improve preventive health care in a cost-effective manner.
Read the detailed description
The study, Online counseling to enable lifestyle-focused obesity treatment in primary care, aims to translate an evidence-based lifestyle intervention into the primary care setting, using information technology to enable clinical lifestyle counseling. While the US Preventive Services Task Force (USPSTF) recommends that clinicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults, multiple barriers to intensive lifestyle counseling exist and the recommendation has not been widely implemented. By requiring physician referral, augmenting the health care team's access to behavioral expertise, and encouraging physician feedback to participating patients, we aim to integrate lifestyle issues into routine preventive medicine. We will examine change in weight, waist circumference, physical activity, quality of life, and will calculate intervention cost-effectiveness. We will ensure sustainability by using recruitment and adherence strategies that can be replicated in routine practice, and counseling staff who are representative of the educators employed in primary care practice. If an online strategy is effective, the extensive network of the University of Pittsburgh Medical Center Health System provides excellent infrastructure for supporting dissemination in the region. As such, this study may facilitate wide-spread adoption of current evidence-based preventive medicine guidelines recommending incorporation of intensive lifestyle interventions into primary care practice.
- Conditions
- Obesity
- Being tested
- VLM-S, VLM-M, OGR
- Keywords
- Obesity, Internet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLM-SBehavioural
Online program for weight loss - standard
VLM-MBehavioural
Online program for weight loss - modulated
OGRBehavioural
Online program for weight loss - resources
| Study group | Role | What they receive |
|---|---|---|
| VLM-S | Experimental | Participants in this arm receive "standard" lifestyle coaching, which is delivered on a specified schedule. They will also receive online information about evidence-based lifestyle goals and links to reputable resources for helping to achieve a healthy lifestyle. Receives: Behavioral: VLM-S |
| VLM-M | Experimental | Participants in this arm receive "modulated" lifestyle coaching, where coaching frequency may be adjusted according to whether the participant is meeting program goals for program use and targeted behaviors. They will also receive online information about evidence-based lifestyle goals and links to reputable resources for helping to achieve a healthy lifestyle. Receives: Behavioral: VLM-M |
| OGR | Active comparator | Participants in this arm will receive online information about evidence-based lifestyle goals and links to reputable resources for helping to achieve a healthy lifestyle, but not personalized lifestyle coaching. Receives: Behavioral: OGR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight (Kg)
Measured: 1 year
Secondary outcomes (8)
% obtaining >7% weight loss
Measured: 1 year
Change in BMI (kg/m2)
Measured: 1 year
Change in waist circumference
Measured: 1 year
Change in steps per day
Measured: 1 year
Change in health-related quality of life as measured by the RAND-36 PCS or MCS
Measured: 1 year
Change in total score on IWQol-Lite
Measured: 1 year
% with >70 meter increase on 6-minute walk
Measured: 1 year
Change in blood pressure (mm Hg)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionSep 2012
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.
- More trials run by University of PittsburghThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Kathleen McTigue, University of Pittsburgh
- Investigators
- Kathleen M McTigue, MD, MS, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044147
- Sponsor's protocol ID
- 1R18HS018155
- Acronym
- OCELOT-PC
- Status last verified
- Jan 2016
- First submitted
- 5 Jan 2010
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
PubMed 12453955
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Counseling to Enable Lifestyle-focused Obesity Treatment in Primary Care
- ClinicalTrials.gov ID
- NCT01044147
- Acronym / sponsor ID
- OCELOT-PC / 1R18HS018155
- Conditions
- Obesity
- Keywords
- Obesity, Internet
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 Jan 2010 (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.
With over half of the US population currently overweight and 31% of adults now obese, the primary care setting may represent an important source of weight-loss support, in the interest of cardiovascular prevention. Yet, although the US Preventive Services task force recommends that physicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults, the recommendation has not been widely implemented. The Internet may help overcome many of the barriers that have prevented intensive obesity counseling in the clinical setting. The aim of this study is to examine whether Internet-based interventions for developing healthier lifestyles can improve preventive health care in a cost-effective manner.
Detailed description
The study, Online counseling to enable lifestyle-focused obesity treatment in primary care, aims to translate an evidence-based lifestyle intervention into the primary care setting, using information technology to enable clinical lifestyle counseling. While the US Preventive Services Task Force (USPSTF) recommends that clinicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults, multiple barriers to intensive lifestyle counseling exist and the recommendation has not been widely implemented. By requiring physician referral, augmenting the health care team's access to behavioral expertise, and encouraging physician feedback to participating patients, we aim to integrate lifestyle issues into routine preventive medicine. We will examine change in weight, waist circumference, physical activity, quality of life, and will calculate intervention cost-effectiveness. We will ensure sustainability by using recruitment and adherence strategies that can be replicated in routine practice, and counseling staff who are representative of the educators employed in primary care practice. If an online strategy is effective, the extensive network of the University of Pittsburgh Medical Center Health System provides excellent infrastructure for supporting dissemination in the region. As such, this study may facilitate wide-spread adoption of current evidence-based preventive medicine guidelines recommending incorporation of intensive lifestyle interventions into primary care practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VLM-S | Experimental | Behavioral: VLM-SParticipants in this arm receive "standard" lifestyle coaching, which is delivered on a specified schedule. They will also receive online information about evidence-based lifestyle goals and links to reputable resources for helping to achieve a healthy lifestyle. |
| VLM-M | Experimental | Behavioral: VLM-MParticipants in this arm receive "modulated" lifestyle coaching, where coaching frequency may be adjusted according to whether the participant is meeting program goals for program use and targeted behaviors. They will also receive online information about evidence-based lifestyle goals and links to reputable resources for helping to achieve a healthy lifestyle. |
| OGR | Active comparator | Behavioral: OGRParticipants in this arm will receive online information about evidence-based lifestyle goals and links to reputable resources for helping to achieve a healthy lifestyle, but not personalized lifestyle coaching. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Obese (BMI > 30kg/meters squared)
- Age 21-75
- Receives primary care at a participating primary care clinic in the Pittsburgh, PA area
Key exclusion criteria (15 listed)
- Primary care physician determination that moderate physical activity is not safe or appropriate for the patient
- Pregnancy
- Planned pregnancy in the next 2 years
- Current breast-feeding
- Bariatric surgery in the past 2 years
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 |
|---|---|---|
| VLM-SOnline program for weight loss - standard | Behavioural | VLM-S |
| VLM-MOnline program for weight loss - modulated | Behavioural | VLM-M |
| OGROnline program for weight loss - resources | Behavioural | OGR |
Primary outcome
Change in body weight (Kg)
Time frame: 1 year
8 secondary outcomes
% obtaining >7% weight loss
Time frame: 1 year
Change in BMI (kg/m2)
Time frame: 1 year
Change in waist circumference
Time frame: 1 year
Change in steps per day
Time frame: 1 year
Change in health-related quality of life as measured by the RAND-36 PCS or MCS
Time frame: 1 year
Change in total score on IWQol-Lite
Time frame: 1 year
% with >70 meter increase on 6-minute walk
Time frame: 1 year
Change in blood pressure (mm Hg)
Time frame: 1 year
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 14 Jan 2016.
- Background: PubMed 12453955Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
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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.
Kathleen M McTigue, MD, MS, MPH principal investigator
University of Pittsburgh
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 VLM-S, VLM-M and OGR in people with Obesity, run by University of Pittsburgh 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 3 inclusion and 15 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 14 Jan 2016. 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?
Change in body weight (Kg) (time frame: 1 year). 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 NCT01044147, 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 14 Jan 2016.