AzTrials
AzTrials

ObesityNCT02626819

Improving Weight Management at the VA

A study testing MOVE! Toward Your Goals in people with Obesity, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Obesity
What is being tested?
MOVE! Toward Your Goals
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesUnited States
Study dates
3 Aug 2015to 5 Mar 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

    Brooklyn, New York, 11209

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

    New York, New York, 10010

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Obesity
Being tested
MOVE! Toward Your Goals, Enhanced Usual Care
Keywords
Obesity, Weight Management, Primary Care, Health Coach, iPad, Goal Setting, 5As, technology
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOVE! Toward Your GoalsBehavioural

    Also called MTG arm

    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

  • Enhanced Usual CareBehavioural

    Also called EUC arm

    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.

Study groups in NCT02626819
Study groupRoleWhat they receive
Arm 1: Receiving MOVE! Toward Your GoalsExperimentalReceiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider)
Receives: Behavioral: MOVE! Toward Your Goals
Arm 2: Receiving Enhanced Usual CareActive comparatorReceiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider)
Receives: Behavioral: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Change (kg)

    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.

    Measured: 3 Months

  2. Weight Change (kg)

    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.

    Measured: 6 Months

  3. Weight Change (kg)

    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.

    Measured: 12 months

  4. Percent of Patients With Clinically Significant Weight Loss

    The percentage of patients who achieve 5-10% weight loss at 3- month study visit.

    Measured: 3 months

  5. Percent of Patients With 2.5% Weight Loss at 6 Months.

    Percentage of patients who achieved 2.5% weight loss at 6 months. Weight measured in kg.

    Measured: 6 months

  6. Percent of Patients With Clinically Significant Weight Loss

    The percentage of patients who achieve 5-10% weight loss at 6- month study visit.

    Measured: 6 months

  7. Percent of Patients Who Achieved 2.5% Weight Loss

    Percentage of patients who achieved 2.5% weight loss at 12 months. Weight measured in kg.

    Measured: 12 months

  8. Percent of Patients With Clinically Significant Weight Loss

    The percentage of patients who achieve 5-10% weight loss at 12- month study visit.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2015 (estimated)
  2. Study start3 Aug 2015
  3. Primary completion31 May 2017
  4. Study completion5 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02626819
Sponsor's protocol ID
CDP 12-252
Other IDs
CDA 10-206
Status last verified
Jun 2018
First submitted
29 Sep 2015
Last updated
21 Dec 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25418230

  • 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.

    PubMed 25134692

  • 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.

    PubMed 25214540

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

    PubMed 24785246

  • 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.

  • 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.

    PubMed 26572125

  • 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.

    PubMed 26855786

  • 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.

    PubMed 27364811

Questions about this trial

What is this clinical trial studying?

A study testing MOVE! Toward Your Goals in people with Obesity, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Change (kg) (time frame: 3 Months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02626819, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in