The Peer Assisted Lifestyle Intervention (PAL)

February 9, 2022 updated by: VA Office of Research and Development

Testing the Efficacy of a Technology-assisted Intervention to Improve Weight Management of Obese Patients Within Patient Aligned Care Teams at the VA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

281

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAL Intervention

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)
Behavioral: Peer Assisted Lifestyle
Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.
Other Names:
  • PAL arm
Active Comparator: Enhanced Usual Care (EUC)
Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity
Behavioral: Enhanced Usual Care
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 Names:
  • EUC arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Weight Loss
Time Frame: 6 and 12 months
Mann-Whitney tests for continuous outcomes (e.g., weight loss)
6 and 12 months
Difference in achievement of 5% weight loss
Time Frame: 12 months
Fisher's exact tests for categorical outcomes will be used to compare the two intervention arms at 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in HB A1C
Time Frame: 6 and 12 month
Fasting blood tests will be used to determine if patients experience changes in HB A1C level.
6 and 12 month
Changes in waist circumference
Time Frame: 6 and 12 months
Will be used to determine whether patients had changes in waist circumference.
6 and 12 months
Changes in Physical Activity
Time Frame: 6 and 12 months
Measure duration and intensity using the Paffenbarger questionnaire items and accelerometers. The ActiGraph Link (GT9X) accelerometer, worn on the wrist, will be used to objectively measure PA for 7 days at Baseline, and at 6 and 12 months.
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

May 19, 2017

First Submitted That Met QC Criteria

May 19, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 15-378
  • 01607 (Other Grant/Funding Number: Veterans Administration)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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