The Peer Assisted Lifestyle Intervention

Not Applicable

Completed

Conditions: Overweight
Obesity

Interventions: Behavioral: Peer Assisted Lifestyle
Behavioral: Enhanced Usual Care

Registration Number: NCT03163264

Lead Sponsor: VA Office of Research and Development

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 301

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAL Intervention	Peer Assisted Lifestyle	Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider)
Enhanced Usual Care (EUC)	Enhanced Usual Care	Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity

Primary Outcome Measures

Name	Time	Method
Mean Weight Change in Kg	12 months	Weight change in kg at 12 months
Mean Percent Weight Change From Baseline to 12 Months	12 months	Mann-Whitney tests for continuous outcomes (e.g., weight change)

Secondary Outcome Measures

Name	Time	Method
Achievement of 5% Weight Loss	12 months	Percent of people in each arm attaining \> or = to 5% weight loss
Changes in HB A1C	6 and 12 months	The investigators will extract HB A1C data from the electronic health record. Due to COVID, participants did not have their regular in-person doctor's appointments to test/collect their HB A1C. Due to a large amount of missing HB A1C data, data was not collected/extracted from the electronic health record and therefore changed in HB A1C was not analyzed.
Changes in Waist Circumference	12 months	To determine whether patients had changes in waist circumference. Adjusted changes between baseline and 12 Months. Mean (SD) of adjusted outcomes in each treatment arm are provided.
Changes in Physical Activity	6 and 12 months	Measure duration and intensity using accelerometers. The ActiGraph Link (GT9X) accelerometer, worn on the wrist, was used to objectively measure PA for 7 days at Baseline, and at 6 and 12 months.
Moderate to Vigorous Physical Activity Difference (Minutes)	12 months	Measure duration using the Paffenbarger questionnaire items. Difference in adjusted mean behavioral outcome between the treatment arms. Adjusted mean difference (95% Confidence Interval) \[p-value\] between the treatment arms (PAL - EUC) for each behavioral outcome at 12 (primary) months of follow-up.
Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week	12 months	Adjusted mean percent of people achieving behavioral outcome in each treatment arms. Measured duration using IPAQ questionnaire items.