The Peer Assisted Lifestyle Intervention
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 69 |
| Updated: | 1/6/2019 |
| Start Date: | January 8, 2018 |
| End Date: | December 31, 2020 |
| Contact: | Melanie R Jay, MD MS |
| Email: | Melanie.Jay@va.gov |
| Phone: | (212) 686-7500 |
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.
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.
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
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
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
- Has lost greater than 10% of body weight in last year
- Pregnancy
- PCP stating that Veteran should not participate
We found this trial at
1
site
New York, New York 10010
Principal Investigator: Melanie R. Jay, MD MS
Phone: 212-686-7500
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