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

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT01044147
Collaborator
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
360
1
3
29
12.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: VLM-S
  • Behavioral: VLM-M
  • Behavioral: OGR
Phase 2/Phase 3

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

Study Type:
Interventional
Actual Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Online Counseling to Enable Lifestyle-focused Obesity Treatment in Primary Care
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in body weight (Kg) [1 year]

Secondary Outcome Measures

  1. % obtaining >7% weight loss [1 year]

  2. Change in BMI (kg/m2) [1 year]

  3. Change in waist circumference [1 year]

  4. Change in steps per day [1 year]

  5. Change in health-related quality of life as measured by the RAND-36 PCS or MCS [1 year]

  6. Change in total score on IWQol-Lite [1 year]

  7. % with >70 meter increase on 6-minute walk [1 year]

  8. Change in blood pressure (mm Hg) [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kathleen McTigue, Assitant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01044147
Other Study ID Numbers:
  • 1R18HS018155
First Posted:
Jan 7, 2010
Last Update Posted:
Jan 14, 2016
Last Verified:
Jan 1, 2016
Keywords provided by Kathleen McTigue, Assitant Professor, University of Pittsburgh
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2016