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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: VLM-S
* Behavioral: VLM-M
* Behavioral: OGR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VLM-S<br>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. | Behavioral: VLM-S<br>* Online program for weight loss - standard<br>|
| Experimental: VLM-M<br>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. | Behavioral: VLM-M<br>* Online program for weight loss - modulated<br>|
| Active Comparator: OGR<br>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. | Behavioral: OGR<br>* Online program for weight loss - resources<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight (Kg) |  | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Internet