Online Counseling to Enable Lifestyle-focused Obesity Treatment in Primary Care
OCELOT-PC
1 other identifier
interventional
360
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Apr 2010
Typical duration for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2010
CompletedFirst Posted
Study publicly available on registry
January 7, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJanuary 14, 2016
January 1, 2016
1.7 years
January 5, 2010
January 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body weight (Kg)
1 year
Secondary Outcomes (8)
% obtaining >7% weight loss
1 year
Change in BMI (kg/m2)
1 year
Change in waist circumference
1 year
Change in steps per day
1 year
Change in health-related quality of life as measured by the RAND-36 PCS or MCS
1 year
- +3 more secondary outcomes
Study Arms (3)
VLM-S
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Obese (BMI \> 30kg/meters squared)
- Age 21-75
- Receives primary care at a participating primary care clinic in the Pittsburgh, PA area
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
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.
PMID: 12453955BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen M McTigue, MD, MS, MPH
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assitant Professor
Study Record Dates
First Submitted
January 5, 2010
First Posted
January 7, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2011
Study Completion
September 1, 2012
Last Updated
January 14, 2016
Record last verified: 2016-01