N/A
Completed N=301
The Peer Assisted Lifestyle Intervention
Source: ClinicalTrials.gov NCT03163264 ↗Enrolled (actual)
301
Serious AEs
11.0%
Results posted
Nov 2024
Primary outcomePrimary: Mean Weight Change in Kg — -2.51; -0.79 kilograms (kg) — p=0.050
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Weight Change in Kg |
-2.51; -0.79 | 0.050 |
| PRIMARY Mean Percent Weight Change From Baseline to 12 Months |
-2.32; -0.69 | 0.069 |
| SECONDARY Achievement of 5% Weight Loss |
26; 15 | 0.073 |
| SECONDARY Changes in HB A1C |
— | — |
| SECONDARY Changes in Waist Circumference |
-1.82; -1.40 | 0.378 |
| SECONDARY Changes in Physical Activity |
— | — |
| SECONDARY Moderate to Vigorous Physical Activity Difference (Minutes) |
13.32; 46.15 | 0.648 |
| SECONDARY Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week |
29; 49 | 0.53 |
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
Data sourced from ClinicalTrials.gov (NCT03163264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.