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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-09-30

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.

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

VLM-S

Intervention Type BEHAVIORAL

Online program for weight loss - standard

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.

Group Type EXPERIMENTAL

VLM-M

Intervention Type BEHAVIORAL

Online program for weight loss - modulated

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.

Group Type ACTIVE_COMPARATOR

OGR

Intervention Type BEHAVIORAL

Online program for weight loss - resources

Interventions

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VLM-S

Online program for weight loss - standard

Intervention Type BEHAVIORAL

VLM-M

Online program for weight loss - modulated

Intervention Type BEHAVIORAL

OGR

Online program for weight loss - resources

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No