Obesity, Overweight
Conditions
Keywords
obesity, weight loss, weight gain, weight management, primary care, health coach
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.
Detailed 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 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
Interventions
BEHAVIORALPeer 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.
BEHAVIORALEnhanced 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weight Change in Kg | 12 months | Weight change in kg at 12 months |
| Mean Percent Weight Change From Baseline to 12 Months | 12 months | Mann-Whitney tests for continuous outcomes (e.g., weight change) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Waist Circumference | 6 months | 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. |
| Changes in Physical Activity | 6 and 12 months | 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. |
| Achievement of 5% Weight Loss | 6 months | Percent of people in each arm attaining \> or = to 5% weight loss |
| Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week | 6 months | Adjusted mean percent of people achieving behavioral outcome in each treatment arms. Measured duration using IPAQ questionnaire items. |
| Moderate to Vigorous Physical Activity Difference (Minutes) | 6 months | 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. |
| Changes in HB A1C | 6 and 12 months | 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. |
Countries
United States
Participant flow
Recruitment details
Randomization performed at provider level. Patients recruited from provider panels randomized to each arm (PAL or EUC).
Participants by arm
| Arm | Count |
|---|---|
| PAL Intervention: Patients 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)
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. | 120 |
| Enhanced Usual Care (EUC): Patients Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity
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. | 161 |
| PAL Intervention: Providers Providers at Brooklyn VA with panel size \> 250
Providers received training on the overview of the 5As and the intervention components and practiced brief MI (using role playing) to support Veterans' weight management goals and address barriers to change. | 10 |
| Enhanced Usual Care (EUC): Providers Providers at Brooklyn VA with panel size \> 250
Providers did not receive additional training. | 10 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 17 | 20 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 13 | 3 | 4 | 2 |
Baseline characteristics
| Characteristic | Enhanced Usual Care (EUC): Patients | Total | PAL Intervention: Patients | Enhanced Usual Care (EUC): Providers | PAL Intervention: Providers |
|---|---|---|---|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 11.6 | 50.6 years STANDARD_DEVIATION 11.5 | 51.6 years STANDARD_DEVIATION 11.3 | — | — |
| Body Mass Index | 33.3 kg/m^2 STANDARD_DEVIATION 4.7 | 33.4 kg/m^2 STANDARD_DEVIATION 5.1 | 33.5 kg/m^2 STANDARD_DEVIATION 5.6 | — | — |
| Diastolic blood pressure | 77.8 mmHg STANDARD_DEVIATION 10.5 | 78.5 mmHg STANDARD_DEVIATION 19.9 | 79.3 mmHg STANDARD_DEVIATION 28 | — | — |
| Height | 173.8 centimeters STANDARD_DEVIATION 8.5 | 172.8 centimeters STANDARD_DEVIATION 8.8 | 171.5 centimeters STANDARD_DEVIATION 8.9 | — | — |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 5 Participants | 2 Participants | — | — |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants | — | — |
| Race (NIH/OMB) Black or African American | 97 Participants | 160 Participants | 63 Participants | — | — |
| Race (NIH/OMB) More than one race | 5 Participants | 11 Participants | 6 Participants | — | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants | 35 Participants | 18 Participants | — | — |
| Race (NIH/OMB) White | 36 Participants | 64 Participants | 28 Participants | — | — |
| Region of Enrollment United States | 161 participants | 281 participants | 120 participants | — | — |
| Sex: Female, Male Female | 29 Participants | 71 Participants | 31 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 132 Participants | 230 Participants | 89 Participants | 4 Participants | 5 Participants |
| Systolic blood pressure | 126.9 mmHg STANDARD_DEVIATION 41.9 | 125.6 mmHg STANDARD_DEVIATION 33.1 | 123.8 mmHg STANDARD_DEVIATION 14.4 | — | — |
| Waist Circumference | 42.7 inches (in) STANDARD_DEVIATION 4.7 | 42.8 inches (in) STANDARD_DEVIATION 5.4 | 42.9 inches (in) STANDARD_DEVIATION 6.2 | — | — |
| Weight | 100.8 kg STANDARD_DEVIATION 16.3 | 100.0 kg STANDARD_DEVIATION 18.2 | 98.9 kg STANDARD_DEVIATION 20.4 | — | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 2 / 161 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 36 / 120 | 51 / 161 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 14 / 120 | 17 / 161 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Mean Percent Weight Change From Baseline to 12 Months
Mann-Whitney tests for continuous outcomes (e.g., weight change)
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PAL Intervention | Mean Percent Weight Change From Baseline to 12 Months | -2.32 percent change | Standard Deviation 0.75 |
| Enhanced Usual Care (EUC) | Mean Percent Weight Change From Baseline to 12 Months | -0.69 percent change | Standard Deviation 0.47 |
p-value: 0.06995% CI: [-0.13, 3.39]Mixed Models Analysis
p-value: 0.02895% CI: [0.21, 3.76]Wilcoxon (Mann-Whitney)
Primary
Mean Weight Change in Kg
Weight change in kg at 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PAL Intervention | Mean Weight Change in Kg | -2.51 kilograms (kg) | Standard Deviation 0.73 |
| Enhanced Usual Care (EUC) | Mean Weight Change in Kg | -0.79 kilograms (kg) | Standard Deviation 0.48 |
p-value: 0.0595% CI: [0, 3.45]Mixed Models Analysis
p-value: 0.05Wilcoxon (Mann-Whitney)
Secondary
Achievement of 5% Weight Loss
Percent of people in each arm attaining \> or = to 5% weight loss
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAL Intervention | Achievement of 5% Weight Loss | 17 Percent of people |
| Enhanced Usual Care (EUC) | Achievement of 5% Weight Loss | 6 Percent of people |
p-value: 0.03395% CI: [0.92, 21.45]Mixed Models Analysis
Secondary
Achievement of 5% Weight Loss
Percent of people in each arm attaining \> or = to 5% weight loss
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAL Intervention | Achievement of 5% Weight Loss | 26 Percent of people |
| Enhanced Usual Care (EUC) | Achievement of 5% Weight Loss | 15 Percent of people |
p-value: 0.07395% CI: [-1.05, 23.2]Mixed Models Analysis
Secondary
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
Population: Data were not collected.
Secondary
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
Population: The investigators planned to use accelerometers, given out at each study visit, to measure physical activity for 7 days at baseline, 6 month, and 12 months. However, due to COVID-19, the investigators were unable to give out accelerometers at each visit to collect this data. Therefore, data collection was not completed and outcome will not be reported.
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PAL Intervention | Changes in Waist Circumference | -1.82 inches (in) | Standard Deviation 0.37 |
| Enhanced Usual Care (EUC) | Changes in Waist Circumference | -1.40 inches (in) | Standard Deviation 0.29 |
p-value: 0.37895% CI: [-0.52, 1.37]Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PAL Intervention | Changes in Waist Circumference | -1.44 inches (in) | Standard Deviation 0.31 |
| Enhanced Usual Care (EUC) | Changes in Waist Circumference | -0.72 inches (in) | Standard Deviation 0.23 |
p-value: 0.06595% CI: [-0.05, 1.48]Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PAL Intervention | Moderate to Vigorous Physical Activity Difference (Minutes) | 93.43 minutes | Standard Deviation 57.88 |
| Enhanced Usual Care (EUC) | Moderate to Vigorous Physical Activity Difference (Minutes) | 101.78 minutes | Standard Deviation 43.96 |
p-value: 0.91195% CI: [-138.25, 154.95]Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PAL Intervention | Moderate to Vigorous Physical Activity Difference (Minutes) | 13.32 minutes | Standard Deviation 53.77 |
| Enhanced Usual Care (EUC) | Moderate to Vigorous Physical Activity Difference (Minutes) | 46.15 minutes | Standard Deviation 45.34 |
p-value: 0.64895% CI: [-108.15, 173.81]Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAL Intervention | Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week | 70 percent of people |
| Enhanced Usual Care (EUC) | Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week | 80 percent of people |
p-value: 0.73695% CI: [-49.73, 70.37]Mixed Models Analysis
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAL Intervention | Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week | 29 percent of people |
| Enhanced Usual Care (EUC) | Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week | 49 percent of people |
p-value: 0.5395% CI: [-41.09, 79.8]Mixed Models Analysis