Clinical trial NCT01044147: Online Counseling to Enable Lifestyle-focused Obesity Treatment in Primary Care
Official title: Online Counseling to Enable Lifestyle-focused Obesity Treatment in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Keywords: Obesity
Internet
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2010-01-07
Enrollment: 360
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight (Kg)
timeFrame: 1 year
Secondary outcomes:
measure: % obtaining >7% weight loss
timeFrame: 1 year
measure: Change in BMI (kg/m2)
timeFrame: 1 year
measure: Change in waist circumference
timeFrame: 1 year
measure: Change in steps per day
timeFrame: 1 year
measure: Change in health-related quality of life as measured by the RAND-36 PCS or MCS
timeFrame: 1 year
measure: Change in total score on IWQol-Lite
timeFrame: 1 year
measure: % with >70 meter increase on 6-minute walk
timeFrame: 1 year
measure: Change in blood pressure (mm Hg)
timeFrame: 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kathleen M McTigue, MD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.