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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01044147
Acronym
OCELOT-PC
Enrollment
360
Registered
2010-01-07
Start date
2010-04-30
Completion date
2012-09-30
Last updated
2016-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Internet

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.

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.

Interventions

BEHAVIORALVLM-S

Online program for weight loss - standard

BEHAVIORALVLM-M

Online program for weight loss - modulated

BEHAVIORALOGR

Online program for weight loss - resources

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Change in body weight (Kg)1 year

Secondary

MeasureTime frame
Change in BMI (kg/m2)1 year
Change in waist circumference1 year
Change in steps per day1 year
% obtaining >7% weight loss1 year
Change in total score on IWQol-Lite1 year
% with >70 meter increase on 6-minute walk1 year
Change in blood pressure (mm Hg)1 year
Change in health-related quality of life as measured by the RAND-36 PCS or MCS1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026