Improving Weight Management at the VA

NCT02626819 | Completed Results

• 2 other identifiers: CDP 12-252CDA 10-206
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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.

  3 Months

• 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.

  6 Months

• 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.

  12 months

• Percent of Patients With Clinically Significant Weight Loss

  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.

  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

  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

  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

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

  12 months

Study Arms (2)

Arm 1: Receiving MOVE! Toward Your Goals

EXPERIMENTAL

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

Arm 2: Receiving Enhanced Usual Care

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care

Interventions

MOVE! Toward Your Goals 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

Also known as: MTG arm

Arm 1: Receiving MOVE! Toward Your Goals

Enhanced Usual Care 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.

Also known as: EUC arm

Arm 2: Receiving Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

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

Brooklyn, New York, 11209, United States

Location

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

New York, New York, 10010, United States

Location

Related Publications (16)

• 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.

  PMID: 25418230 BACKGROUND

• 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.

  PMID: 25134692 BACKGROUND

• 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.

  PMID: 25214540 BACKGROUND

• 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.

  BACKGROUND

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

  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.

  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.

  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.

  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.

  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.

  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.

  PMID: 24785246 BACKGROUND

• 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.

  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.

  PMID: 26572125 BACKGROUND

• 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.

  PMID: 26855786 BACKGROUND

• 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.

  PMID: 27364811 BACKGROUND

• 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.

  PMID: 27716279 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

* Small sample size, thus unpowered to see significant results * Low yield of recruitment * Research Assistants not blinded to study arm

Results Point of Contact

• Title: Melanie Jay, MD MS
• Organization: Manhattan Campus of the VA NY Harbor Healthcare System

melanie.jay@va.gov

212-686-7500

Study Officials

• Melanie R. Jay, MD MS

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinded to intervention arm
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: December 10, 2015
• Study Start: August 3, 2015
• Primary Completion: May 31, 2017
• Study Completion: March 5, 2018
• Last Updated: December 21, 2018
• Results First Posted: December 21, 2018

Record last verified: 2018-06

Locations

US (2)