ClinicalTrials.Veeva

Menu

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

University of Pittsburgh logo

University of Pittsburgh

Status and phase

Completed
Phase 3
Phase 2

Conditions

Obesity

Treatments

Behavioral: VLM-S
Behavioral: OGR
Behavioral: VLM-M

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01044147
1R18HS018155

Details and patient eligibility

About

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.

Full 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.

Enrollment

360 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

360 participants in 3 patient groups

VLM-S
Experimental group
Description:
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.
Treatment:
Behavioral: VLM-S
VLM-M
Experimental group
Description:
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.
Treatment:
Behavioral: VLM-M
OGR
Active Comparator group
Description:
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.
Treatment:
Behavioral: OGR

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems