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Improving Weight Management at the VA

NCT ID: NCT02626819

Last Updated: 2018-12-21

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-03

Study Completion Date

2018-03-05

Brief Summary

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Compared to the general public, a higher percentage of Veterans are obese or overweight with a weight-related medical condition. The VA currently offers an effective weight management program called MOVE!, but the majority of eligible patients do not attend. Veterans see their primary care providers (PCPs) very frequently, making it an important place to receive information on weight management. However, PCPs often fail to discuss weight management with patients, so interventions are needed to encourage weight management counseling within the team-based care model used in primary care at the VA. Investigators used focus groups, interviews, and other research methods to develop the MOVE! Toward Your Goals (MTG) intervention. This intervention combines online tools, counseling by a health coach, and the team-based care model to deliver weight management information to patients.

Investigators will conduct a randomized controlled trial of 320 Veteran patients and their providers at two VA sites (Manhattan and Brooklyn campuses, New York Harbor Healthcare System) to study the impact of the 12-month MTG intervention when compared to Enhanced Usual Care. Veterans in the MTG intervention arm will take the MTG tool, receive personalized weight management materials, health coach counseling, and go to their scheduled primary care (PC) visit. After the initial visit, MTG-arm Veterans will receive follow up telephone coaching over 12 months. All Veterans will attend follow-up visits at 3, 6 and 12 months to assess body mass index, diet and physical activity, and goal attainment.

The objectives of this study are to: (a) test the impact of the MTG intervention on weight and behavior changes; (b) identify predictors of weight loss in Veterans who use goal setting techniques; and (c) determine the impact of the MTG intervention on primary care team obesity-related counseling practices and attitudes.

Detailed Description

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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 \[5A\]) 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.

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. Investigators did formative work using key informant interviews with several VA Patient Aligned Care Teams (PACT), 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, 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 12 health coaching calls over 1 year.

Investigators will conduct a large, multicenter (Manhattan and Brooklyn campuses, New York Harbor Healthcare System) randomized controlled trial of 320 subjects, who will be randomized to receive either Enhanced Usual Care or the MTG Intervention.

The objectives of this study are to: (a) test the impact of the MTG intervention on weight and behavior changes; (b) identify predictors of weight loss in Veterans who use goal setting techniques; and (c) determine the impact of the MTG intervention on primary care team obesity-related counseling practices and attitudes.

Conditions

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Obesity

Keywords

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Obesity Weight Management Primary Care Health Coach iPad Goal Setting 5As technology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Blinded to intervention arm

Study Groups

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Arm 1: Receiving MOVE! Toward Your Goals

Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider)

Group Type EXPERIMENTAL

MOVE! Toward Your Goals

Intervention Type BEHAVIORAL

Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members

Arm 2: Receiving Enhanced Usual Care

Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider)

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type BEHAVIORAL

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.

Interventions

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MOVE! Toward Your Goals

Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MTG arm EUC arm

Eligibility Criteria

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Inclusion Criteria

* Has not participated in MOVE! in the past year
* Age 18-69 (this age range represents MOVE! eligibility)
* BMI of 30kg/m2 or a BMI of 25 kg/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 or Manhattan VA for in-person evaluations at 3, 6, and 12 months

Exclusion Criteria

* Non-Veterans
* A documented current history of active psychosis or other cognitive issues via International Classification of Diseases (ICD-9) codes
* Diabetes diagnosis via ICD-9 code
* Primary care provider recommends that the patient should not participate
* Severe arthritis, valvular disease, cardiac arrhythmia, pregnancy, and/or other conditions (indicated by PCP) limiting moderate PA
* Self-reported inability to read at a 5th grade level due to literacy level or vision problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melanie R. Jay, MD MS

Role: PRINCIPAL_INVESTIGATOR

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Locations

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Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY

Brooklyn, New York, United States

Site Status

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Site Status

Countries

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United States

References

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Jay M, Gutnick D, Squires A, Tagliaferro B, Gerchow L, Savarimuthu S, Chintapalli S, Shedlin MG, Kalet A. In our country tortilla doesn't make us fat: cultural factors influencing lifestyle goal-setting for overweight and obese Urban, Latina patients. J Health Care Poor Underserved. 2014 Nov;25(4):1603-22. doi: 10.1353/hpu.2014.0165.

Reference Type BACKGROUND
PMID: 25418230 (View on PubMed)

Levine DM, Savarimuthu S, Squires A, Nicholson J, Jay M. Technology-assisted weight loss interventions in primary care: a systematic review. J Gen Intern Med. 2015 Jan;30(1):107-17. doi: 10.1007/s11606-014-2987-6. Epub 2014 Aug 19.

Reference Type BACKGROUND
PMID: 25134692 (View on PubMed)

Acosta A, Azzalin A, Emmons CJ, Shuster JJ, Jay M, Lo MC. Improving residents' clinical approach to obesity: impact of a multidisciplinary didactic curriculum. Postgrad Med J. 2014 Nov;90(1069):630-7. doi: 10.1136/postgradmedj-2014-132821. Epub 2014 Sep 11.

Reference Type BACKGROUND
PMID: 25214540 (View on PubMed)

Perez H, Jay MR. Good Midlife Dietary Habits May Increase Likelihood of Healthy Aging - Article Review. Journal of clinical outcomes management : JCOM. 2014 Jan 1; 21(3):105-9.

Reference Type BACKGROUND

Levine D, Jay MR. Another Win for Veggies - Article Review. Journal of clinical outcomes management : JCOM. 2014 Jan 1; 21(5):207-9.

Reference Type BACKGROUND

Mateo KF, Jay MR. Access to a Behavioral Weight Loss Website With or Without Group Sessions Increased Weight Loss in Statewide Campaign - Article Review. Journal of clinical outcomes management : JCOM. 2014 Jan 1; 21(8):345-8.

Reference Type BACKGROUND

Creighton S, Jay MR. Are Non-Nutritive Sweetened Beverages Comparable to Water in Weight Loss Trials. Journal of clinical outcomes management : JCOM. 2014 Jan 1; 21(11):490-2.

Reference Type BACKGROUND

Jay MR, Chintapalli S, Oi K, Squires A, Sherman S, Kalet A. Identifying barrier and facilitators to improving the implementation of weight management services within a patient-centered medical home. [Abstract]. Journal of general internal medicine. 2014 Apr 25; 29(Supplement 1):S115.

Reference Type BACKGROUND

Jay MR, Mateo KM, Horne M, Squires A, Kalet A, Sherman S. "In the military, your body and your life aren't your own": Unique factors influencing health behavior change in overweight and obese veterans. Journal of general internal medicine. 2014 Apr 25; 29(Supplement 1):S3.

Reference Type BACKGROUND

Perez HR, Nick MW, Mateo KM, Sherman S, Kalet A, Jay MR. "None of them apply to me": A usability study of the VA's MOVE!23 online weight management software in Latina Women. Journal of general internal medicine. 2014 Apr 23; 29(Supplement 1):S4.

Reference Type BACKGROUND

Gerchow L, Tagliaferro B, Squires A, Nicholson J, Savarimuthu SM, Gutnick D, Jay M. Latina food patterns in the United States: a qualitative metasynthesis. Nurs Res. 2014 May-Jun;63(3):182-93. doi: 10.1097/NNR.0000000000000030.

Reference Type BACKGROUND
PMID: 24785246 (View on PubMed)

Gutnick D, Reims K, Davis C, Gainforth H, Jay MR, Cole S. Brief Action Planning to Facilitate Behavior Change and Support Patient Self-Management. Journal of clinical outcomes management : JCOM. 2014 Jan 1; 21(1):17-29.

Reference Type BACKGROUND

Jay M, Chintapalli S, Squires A, Mateo KF, Sherman SE, Kalet AL. Barriers and facilitators to providing primary care-based weight management services in a patient centered medical home for Veterans: a qualitative study. BMC Fam Pract. 2015 Nov 14;16:167. doi: 10.1186/s12875-015-0383-x.

Reference Type BACKGROUND
PMID: 26572125 (View on PubMed)

Jay M, Mateo KF, Squires AP, Kalet AL, Sherman SE. Military service and other socioecological factors influencing weight and health behavior change in overweight and obese Veterans: a qualitative study to inform intervention development within primary care at the United States Veterans Health Administration. BMC Obes. 2016 Feb 1;3:5. doi: 10.1186/s40608-016-0087-3. eCollection 2015.

Reference Type BACKGROUND
PMID: 26855786 (View on PubMed)

Rogers ES, Sherman SE, Malaspina D, Jay M. Prevalence and Predictors of Obesity-Related Counseling Provided by Outpatient Psychiatrists in the United States. Psychiatr Serv. 2016 Oct 1;67(10):1156-1159. doi: 10.1176/appi.ps.201500345. Epub 2016 Jul 1.

Reference Type BACKGROUND
PMID: 27364811 (View on PubMed)

Perez HR, Nick MW, Mateo KF, Squires A, Sherman SE, Kalet A, Jay M. Adapting a weight management tool for Latina women: a usability study of the Veteran Health Administration's MOVE!23 tool. BMC Med Inform Decis Mak. 2016 Oct 5;16(1):128. doi: 10.1186/s12911-016-0368-2.

Reference Type BACKGROUND
PMID: 27716279 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CDA 10-206

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDP 12-252

Identifier Type: -

Identifier Source: org_study_id