The Peer Assisted Lifestyle Intervention
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The PAL intervention uses a new software tool delivered on tablets to facilitate 5As-based
      weight management counseling with a health coach and the VA PACT healthcare team to promote
      goal-setting, behavior change, and weight loss in the primary care (PC) setting. The PAL
      intervention also includes 10-12 health-coaching calls to the patient over 12 months.

      As part of a cluster-randomized controlled study, the investigators will randomize 17 PACT
      teams at the Brooklyn VA to receive either the PAL Intervention or an Enhanced Usual Care
      control. The primary aim of the study is to explore differences in feasibility,
      acceptability, and intermediate, behavioral, and weight loss outcomes at 6 and 12 months of
      520 patients recruited from the randomized PACTs.

      Objective:

      1) Explore the feasibility and impact of this intervention on intermediate, behavioral, and
      weight loss outcomes at 6 and 12 months post-intervention when compared to enhanced usual
      care.
    

Detailed 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 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
    

Intervention name(s): Peer Assisted Lifestyle; Enhanced Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.; Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Other intervention name(s): PAL arm; EUC arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: obesity; weight loss; weight gain; weight management; primary care; health coach