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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Behavioral: VLM-S; Behavioral: OGR; Behavioral: VLM-M

• Registration Number: NCT01044147
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-07
• Study Start: 2010-04
• Primary Completion: 2011-12
• Study Completion: 2012-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Obese (BMI > 30kg/meters squared)
• Age 21-75
• Receives primary care at a participating primary care clinic in the Pittsburgh, PA area

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VLM-S	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.
OGR	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.
VLM-M	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.

Primary Outcome Measures

Name	Time	Method
Change in body weight (Kg)	1 year

Secondary Outcome Measures

Name	Time	Method
Change in health-related quality of life as measured by the RAND-36 PCS or MCS	1 year
Change in BMI (kg/m2)	1 year
Change in total score on IWQol-Lite	1 year
Change in steps per day	1 year
% with >70 meter increase on 6-minute walk	1 year
% obtaining >7% weight loss	1 year
Change in waist circumference	1 year
Change in blood pressure (mm Hg)	1 year

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States