Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Obesity
  • Overweight
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 69 years
Gender
Both males and females

Description

Veterans shoulder a disproportionate burden of obesity and its co-morbidities, including diabetes, hypertension, and hyperlipidemia. Modest weight loss in obese patients through diet and exercise improves health and prevents chronic disease, but primary care providers (PCPs) often fail to adequately...

Veterans shoulder a disproportionate burden of obesity and its co-morbidities, including diabetes, hypertension, and hyperlipidemia. Modest weight loss in obese patients through diet and exercise improves health and prevents chronic disease, but primary care providers (PCPs) often fail to adequately counsel patients about their weight due to lack of time and training. Thus, tools and brief interventions are needed to support providers' behavior change counseling. The VA currently offers the MOVE! program to treat overweight and obese patients, but only 9% of eligible patients attend. At the same time, Veterans on average see their PCPs 3.6 times per year, which supports the importance of developing primary care (PC)-based interventions. The United States Preventive Services Task force (USPSTF) recommends the use of the 5As framework (Assess, Advise, Agree, Assist, Arrange) for counseling patients about weight. Interactive behavior change technologies utilizing expert system software programs are an innovative way to facilitate 5As counseling to promote behavior change in primary care. These programs perform computerized risk, lifestyle, and theory- based, behavioral assessment to provide computer-generated, tailored advice to patients. They also can provide information to healthcare teams. The MOVE!11 software is an expert system program for VA patients referred to MOVE!, but is not currently used in primary care by Patient-Aligned Care Teams (PACT). Collaborative goal setting can be used to achieve behavior change in this intervention. This construct, a critical component of several behavior change theories and models and corresponding to "agree" in the 5As model, has been widely recommended for health promotion in primary care. The investigators' formative work (MIRB #01333) using key informant interviews with PACT teamlets and MOVE! staff and focus groups with Veterans demonstrated that goal setting is feasible and acceptable to patients and PACT teamlets and provided insight on barriers to goal setting, and ways to facilitate goal-setting conversations. During the development phase of this project, the investigators developed a primary care-based intervention called MOVE! Toward Your Goals (MTG) to facilitate weight management within primary care and increase adoption of intensive VA programs such as MOVE!. The PAL intervention uses the MTG software tool (that the investigators developed) delivered on tablets to facilitate 5As-based weight management counseling with a health coach and healthcare team to promote goal-setting, behavior change, and weight loss in the primary care setting. The Veteran also receives follow up with 10-12 health coaching calls over 1 year. As part of a clustered randomized control trial, the investigators will randomize 17 PACT teams to either Enhanced Usual Care or the PAL Intervention, recruiting 520 subjects. STUDY OBJECTIVES Test the impact of the PAL intervention on weight change and behavioral/clinical outcomes Identify predictors of weight loss in Veterans participating in the intervention group related to goal setting processes and intervention components Determine the impact of the PAL intervention on PACT obesity-related counseling practices and attitudes

Tracking Information

NCT #
NCT03163264
Collaborators
Not Provided
Investigators
Principal Investigator: Melanie R. Jay, MD MS Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY