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.
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 primary care providers 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 obesity-related counseling practices and attitudes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
301
Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.
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.
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, United States
Mean Weight Change in Kg
Weight change in kg at 12 months
Time frame: 12 months
Mean Percent Weight Change From Baseline to 12 Months
Mann-Whitney tests for continuous outcomes (e.g., weight change)
Time frame: 12 months
Achievement of 5% Weight Loss
Percent of people in each arm attaining \> or = to 5% weight loss
Time frame: 6 months
Achievement of 5% Weight Loss
Percent of people in each arm attaining \> or = to 5% weight loss
Time frame: 12 months
Changes in HB A1C
The investigators will extract HB A1C data from the electronic health record. Due to COVID, participants did not have their regular in-person doctor's appointments to test/collect their HB A1C. Due to a large amount of missing HB A1C data, data was not collected/extracted from the electronic health record and therefore changed in HB A1C was not analyzed.
Time frame: 6 and 12 months
Changes in Waist Circumference
To determine whether patients had changes in waist circumference. Adjusted changes between baseline and 6 Months. Mean (SD) of adjusted outcomes in each treatment arm are provided.
Time frame: 6 months
Changes in Waist Circumference
To determine whether patients had changes in waist circumference. Adjusted changes between baseline and 12 Months. Mean (SD) of adjusted outcomes in each treatment arm are provided.
Time frame: 12 months
Changes in Physical Activity
Measure duration and intensity using accelerometers. The ActiGraph Link (GT9X) accelerometer, worn on the wrist, was used to objectively measure PA for 7 days at Baseline, and at 6 and 12 months.
Time frame: 6 and 12 months
Moderate to Vigorous Physical Activity Difference (Minutes)
Measure duration using the Paffenbarger questionnaire items. Difference in adjusted mean behavioral outcome between the treatment arms. Adjusted mean difference (95% Confidence Interval) \[p-value\] between the treatment arms (PAL - EUC) for each behavioral outcome at 6 months of follow-up.
Time frame: 6 months
Moderate to Vigorous Physical Activity Difference (Minutes)
Measure duration using the Paffenbarger questionnaire items. Difference in adjusted mean behavioral outcome between the treatment arms. Adjusted mean difference (95% Confidence Interval) \[p-value\] between the treatment arms (PAL - EUC) for each behavioral outcome at 12 (primary) months of follow-up.
Time frame: 12 months
Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week
Adjusted mean percent of people achieving behavioral outcome in each treatment arms. Measured duration using IPAQ questionnaire items.
Time frame: 6 months
Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week
Adjusted mean percent of people achieving behavioral outcome in each treatment arms. Measured duration using IPAQ questionnaire items.
Time frame: 12 months
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