The Peer Assisted Lifestyle Intervention

Obesity Clinical Trial

— PAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163264
• Other study ID #: IIR 15-378
• Secondary ID: 01607
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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-coachi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Weight Loss	Mann-Whitney tests for continuous outcomes (e.g., weight loss)	6 and 12 months
Primary	Difference in achievement of 5% weight loss	Fisher's exact tests for categorical outcomes will be used to compare the two intervention arms at 12 months	12 months
Secondary	Changes in HB A1C	Fasting blood tests will be used to determine if patients experience changes in HB A1C level.	6 and 12 month
Secondary	Changes in waist circumference	Will be used to determine whether patients had changes in waist circumference.	6 and 12 months
Secondary	Changes in Physical Activity	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