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

January 13, 2016 updated by: Kathleen McTigue, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VLM-S
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.
Behavioral: VLM-S
Online program for weight loss - standard
Experimental: VLM-M
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.
Behavioral: VLM-M
Online program for weight loss - modulated
Active Comparator: OGR
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.
Behavioral: OGR
Online program for weight loss - resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight (Kg)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
% obtaining >7% weight loss
Time Frame: 1 year
1 year
Change in BMI (kg/m2)
Time Frame: 1 year
1 year
Change in waist circumference
Time Frame: 1 year
1 year
Change in steps per day
Time Frame: 1 year
1 year
Change in health-related quality of life as measured by the RAND-36 PCS or MCS
Time Frame: 1 year
1 year
Change in total score on IWQol-Lite
Time Frame: 1 year
1 year
% with >70 meter increase on 6-minute walk
Time Frame: 1 year
1 year
Change in blood pressure (mm Hg)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Kathleen M McTigue, MD, MS, MPH, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 7, 2010

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R18HS018155 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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