The Peer Asssisted Lifestyle Intervention

ID: NCT03163264
Status: Recruiting
Phase: N/A
Start Date: January 08, 2018
First Submitted: May 19, 2017
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: VA Office of Research and Development
Location: United States
Conditions: Obesity, Overweight
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Study Description

Brief Summary

The MTG intervention uses a new MTG 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 MTG intervention also includes 10-15 health-coaching calls to the patient over 12 months.

As part of a cluster-randomized controlled study, the investigators will randomize 10 PACT teams at the Brooklyn VA to receive either the MTG 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 3, 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 3, 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 MTG intervention uses a new 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 10 PACT teams to either Enhanced Usual Care or the MTG Intervention, recruiting 520 subjects.

STUDY OBJECTIVES

- Test the impact of the MTG 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 MTG intervention on PACT obesity-related counseling practices and attitudes
Condition or disease Intervention/treatment Phase

Obesity

Overweight

Behavioral: Peer Assisted Lifestyle
Other Names
PAL arm
Behavioral: Enhanced Usual Care
Other Names
EUC arm
N/A

Tracking Information

First Submitted DateMay 19, 2017
Last Update Posted DateFebruary 23, 2018
Actual Start DateJanuary 08, 2018
Anticipated Completion DateDecember 31, 2020
Actual Primary Completion DateJune 30, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Mean Weight Loss [Time Frame: 6 and 12 months]

    Mann-Whitney tests for continuous outcomes (e.g., weight loss)

  • Difference in achievement of 5% weight loss [Time Frame: 12 months]

    Fisher's exact tests for categorical outcomes will be used to compare the two intervention arms at 12 months

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Changes in HB A1C [Time Frame: 6 and 12 month]

    Fasting blood tests will be used to determine if patients experience changes in HB A1C level.

  • Changes in waist circumference [Time Frame: 6 and 12 months]

    Will be used to determine whether patients had changes in waist circumference.

  • Changes in Physical Activity [Time Frame: 6 and 12 months]

    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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleThe Peer Asssisted Lifestyle Intervention
Official TitleTesting the Efficacy of a Technology-assisted Intervention to Improve Weight Management of Obese Patients Within Patient Aligned Care Teams at the VA
Brief Summary

The MTG intervention uses a new MTG 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 MTG intervention also includes 10-15 health-coaching calls to the patient over 12 months.

As part of a cluster-randomized controlled study, the investigators will randomize 10 PACT teams at the Brooklyn VA to receive either the MTG 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 3, 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 3, 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 MTG intervention uses a new 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 10 PACT teams to either Enhanced Usual Care or the MTG Intervention, recruiting 520 subjects.

STUDY OBJECTIVES

- Test the impact of the MTG 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 MTG intervention on PACT obesity-related counseling practices and attitudes

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
520
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Supportive Care
Conditions
Obesity
Overweight
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
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.

Other Names
PAL arm
Behavioral: 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.

Other Names
EUC arm
Study Groups/Cohorts
PAL Intervention
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)

Enhanced Usual Care (EUC)
Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity

Study Arms
Active Comparator Enhanced Usual Care (EUC)
Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity
Behavioral : 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.

Experimental PAL Intervention
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)
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.

Arm Intervention/Treatment
Active Comparator Enhanced Usual Care (EUC)
Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity
Behavioral : Enhanced Usual Care
Experimental PAL Intervention
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)
Behavioral : Peer Assisted Lifestyle

Recruitment Information

Recruitment Status:Recruiting
Enrollment520
Completion DateDecember 31, 2020
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 12 months
- Access to a telephone
- Able to travel to Brooklyn VA for in-person evaluations at baseline, 3, 6, 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 participated in MOVE! in the past year or has lost greater than 10% of body weight
- Pregnancy
- PCP stating that Veteran should not participate
GenderAll
Age18 Years to 69 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03163264
Other Study ID Numbers
IIR 15-378
01607
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
VA Office of Research and Development
Collaborators
Not Available
Investigators
Principal Investigator
Melanie R. Jay, MD MS
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY