Clinical trial NCT03163264: The Peer Assisted Lifestyle Intervention
Official title: Testing the Efficacy of a Technology-assisted Intervention to Improve Weight Management of Obese Patients Within Patient Aligned Care Teams at the VA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: obesity
weight loss
weight gain
weight management
primary care
health coach
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-05-23
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The PAL intervention uses a new software tool delivered on tablets to facilitate 5As-based weight management counseling with a peer 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 primary care providers 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 primary care providers.

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 primary care providers 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 obesity-related counseling practices and attitudes

Eligibility criteria: Inclusion Criteria:

* Age 18-69 (this age range represents MOVE! eligibility)
* BMI of 30kg/m2 or a BMI of 25kg/m2 with obesity-associated condition
* Under the care of PCP with at least 1 prior visit with the provider in the past 24 months
* Access to a telephone
* Able to travel to Brooklyn VA for in-person evaluations at baseline, 6, and 12 months

Exclusion Criteria:

* Non-Veterans
* A documented current history of active psychosis, active bipolar disorder, or other cognitive issues via ICD-10 codes
* Undergoing insulin-therapy for diabetes
* Self-reported inability to read at a 5th grade level due to literacy level or vision problems
* Has attended more than 4 MOVE! sessions in the past year
* Pregnancy
* PCP stating that Veteran should not participate

Primary outcomes:
measure: Mean Weight Change in Kg
timeFrame: 12 months
measure: Mean Percent Weight Change From Baseline to 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Achievement of 5% Weight Loss
timeFrame: 6 months
measure: Achievement of 5% Weight Loss
timeFrame: 12 months
measure: Changes in HB A1C
timeFrame: 6 and 12 months
measure: Changes in Waist Circumference
timeFrame: 6 months
measure: Changes in Waist Circumference
timeFrame: 12 months
measure: Changes in Physical Activity
timeFrame: 6 and 12 months
measure: Moderate to Vigorous Physical Activity Difference (Minutes)
timeFrame: 6 months
measure: Moderate to Vigorous Physical Activity Difference (Minutes)
timeFrame: 12 months
measure: Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week
timeFrame: 6 months
measure: Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
state: New York
Study officials:
affiliation: Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
name: Melanie R. Jay, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wittleder S, Smith S, Wang B, Beasley JM, Orstad SL, Sweat V, Squires A, Wong L, Fang Y, Doebrich P, Gutnick D, Tenner C, Sherman SE, Jay M. Peer-Assisted Lifestyle (PAL) intervention: a protocol of a cluster-randomised controlled trial of a health-coaching intervention delivered by veteran peers to improve obesity treatment in primary care. BMJ Open. 2021 Feb 26;11(2):e043013. doi: 10.1136/bmjopen-2020-043013.