Improving Weight Management at the VA

June 1, 2018 updated by: VA Office of Research and Development

Improving Weight Management at VA: Enhancing the MOVE!23 for Primary Care (CDA 10-206)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 [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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11209
        • Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY
      • New York, New York, United States, 10010
        • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Behavioral: 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
Other Names:
  • MTG arm
Active Comparator: 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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Change (kg)
Time Frame: 3 Months
Weight Change from baseline to 3 months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.
3 Months
Weight Change (kg)
Time Frame: 6 Months
Change in weight from baseline to 6-months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.
6 Months
Weight Change (kg)
Time Frame: 12 months
Change in weight from baseline to the 12-months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.
12 months
Percent of Patients With Clinically Significant Weight Loss
Time Frame: 3 months
The percentage of patients who achieve 5-10% weight loss at 3- month study visit.
3 months
Percent of Patients With 2.5% Weight Loss at 6 Months.
Time Frame: 6 months
Percentage of patients who achieved 2.5% weight loss at 6 months. Weight measured in kg.
6 months
Percent of Patients With Clinically Significant Weight Loss
Time Frame: 6 months
The percentage of patients who achieve 5-10% weight loss at 6- month study visit.
6 months
Percent of Patients Who Achieved 2.5% Weight Loss
Time Frame: 12 months
Percentage of patients who achieved 2.5% weight loss at 12 months. Weight measured in kg.
12 months
Percent of Patients With Clinically Significant Weight Loss
Time Frame: 12 months
The percentage of patients who achieve 5-10% weight loss at 12- month study visit.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2015

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

March 5, 2018

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDP 12-252
  • CDA 10-206 (Other Grant/Funding Number: Veterans Administration)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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