Text Size

Online Counseling to Enable Lifestyle-focused Obesity Treatment in Primary Care (OCELOT-PC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Kathleen McTigue, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01044147
First received: January 5, 2010
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
 Behavioral: VLM-S
Behavioral: VLM-M
Behavioral: OGR
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Online Counseling to Enable Lifestyle-focused Obesity Treatment in Primary Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change in body weight (Kg) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % obtaining >7% weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in BMI (kg/m2) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in waist circumference [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in steps per day [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in health-related quality of life as measured by the RAND-36 PCS or MCS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in total score on IWQol-Lite [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • % with >70 meter increase on 6-minute walk [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in blood pressure (mm Hg) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: April 2010
Estimated Study Completion Date: September 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VLM-S Behavioral: VLM-S
Online program for weight loss - standard
Experimental: VLM-M Behavioral: VLM-M
Online program for weight loss - modulated
Active Comparator: OGR Behavioral: OGR
Online program for weight loss - resources

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese (BMI > 30kg/meters squared)
  • Age 21-75
  • Receives primary care at a participating primary care clinic in the Pittsburgh, PA area

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044147

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Kathleen M McTigue, MD, MS, MPH University of Pittsburgh
  More Information

Publications:

Responsible Party: Kathleen McTigue, Assitant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01044147     History of Changes
Other Study ID Numbers: 1R18HS018155
Study First Received: January 5, 2010
Last Updated: April 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Obesity
Internet

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013