The Peer Assisted Lifestyle Intervention

NCT03163264 | Completed Results DMC

• 2 other identifiers: IIR 15-37801607
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Keywords

obesity; weight loss; weight gain; weight management; primary care; health coach

Outcome Measures

Primary Outcomes (2)

• Mean Weight Change in Kg

  Weight change in kg at 12 months

  12 months

• Mean Percent Weight Change From Baseline to 12 Months

  Mann-Whitney tests for continuous outcomes (e.g., weight change)

  12 months

Secondary Outcomes (10)

• Achievement of 5% Weight Loss

  6 months

• Achievement of 5% Weight Loss

  12 months

• Changes in HB A1C

  6 and 12 months

• Changes in Waist Circumference

  6 months

• Changes in Waist Circumference

  12 months

Study Arms (2)

PAL Intervention

EXPERIMENTAL

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

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity

Behavioral: Enhanced Usual Care

Interventions

Peer Assisted Lifestyle BEHAVIORAL

Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.

Also known as: PAL arm

PAL Intervention

Enhanced Usual Care BEHAVIORAL

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.

Also known as: EUC arm

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010, United States

Location

Related Publications (2)

• 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.

  PMID: 33637544 RESULT

• Wittleder S, Wong L, Ruan AM, Illenberger N, Nicholson A, Portelli D, Cansler R, Tenner CT, Sherman SE, Aguilar AD, Sweat V, Orstad SL, Vandyousefi S, Fronshtein M, Smith S, Dixon A, Goldstein MG, Raffa SD, Wylie-Rosett J, Jay M. Peer Coaching to Support Weight Management in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529136. doi: 10.1001/jamanetworkopen.2025.29136.

  PMID: 40892413 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Weight Gain

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Limitations and Caveats

The COVID-19 pandemic was a limitation that impacted recruitment and decreased our power to see significant differences.

Results Point of Contact

• Title: Dr. Melanie Jay
• Organization: VA New York Harbor Manhattan

melanie.jay@va.gov

212-686-7500

Study Officials

• Melanie R. Jay, MD MS

  Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 23, 2017
• Study Start: January 8, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 19, 2024
• Results First Posted: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)