A Phase 2/3 interventional study of VLM-S and VLM-M in Obesity, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-01-14.
Sponsored by University of Pittsburgh · Phase 2/3, Interventional, and Treatment
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.
This study's enrollment of 360 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Online program for weight loss - standard
Online program for weight loss - modulated
Online program for weight loss - resources
Change in body weight (Kg)
Time frame: 1 year
% obtaining >7% weight loss
Time frame: 1 year
Change in BMI (kg/m2)
Time frame: 1 year
Change in waist circumference
Time frame: 1 year
Change in steps per day
Time frame: 1 year
Change in health-related quality of life as measured by the RAND-36 PCS or MCS
Time frame: 1 year
Change in total score on IWQol-Lite
Time frame: 1 year
% with >70 meter increase on 6-minute walk
Time frame: 1 year
Change in blood pressure (mm Hg)
Time frame: 1 year
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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