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OpenTrials
Completed

NCT Number: NCT01044147

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

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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VLM-S

Behavioral

Online program for weight loss - standard

VLM-M

Behavioral

Online program for weight loss - modulated

OGR

Behavioral

Online program for weight loss - resources

Primary outcomes

  1. Change in body weight (Kg)

    Time frame: 1 year

Secondary outcomes

  1. % obtaining >7% weight loss

    Time frame: 1 year

  2. Change in BMI (kg/m2)

    Time frame: 1 year

  3. Change in waist circumference

    Time frame: 1 year

  4. Change in steps per day

    Time frame: 1 year

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

    Time frame: 1 year

  6. Change in total score on IWQol-Lite

    Time frame: 1 year

  7. % with >70 meter increase on 6-minute walk

    Time frame: 1 year

  8. Change in blood pressure (mm Hg)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Acronym: OCELOT-PC

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jan 7, 2010
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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