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The Peer Assisted Lifestyle Intervention

NCT03163264 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2024-11-19

Study results available
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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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Melanie R. Jay, MD MS · Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163264 on ClinicalTrials.gov