MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in the Veterans Health Administration (VHA)

NCT01339390 | Completed Results

• 2 other identifiers: IIR 10-3271I01HX000562-01A1
• Study Type: interventional
• Target: 3,169
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity has been linked to several serious medical conditions, including high blood pressure, diabetes, and poor cholesterol levels. For this reason, obesity is likely the most important single contributor to cardiovascular mortality in the United States. Fortunately, intensive weight management programs are an effective treatment for obesity. Such programs help people lose weight and improve their measures of cardiac risk. In response to the growing numbers of obese Veterans being treated at Veterans Health Administration (VHA) facilities, the VHA developed the MOVE! Program. Veterans who commit to MOVE! and participate actively do lose weight. Unfortunately, MOVE!, like other weight management programs, requires its participants to attend classes and to exercise, often at locations and times that are inconvenient. The investigators propose to make it easier for eligible patients at the Zablocki Veterans Affairs Medical Center (ZVAMC) to participate by offering MOVE-style classes and exercise groups at a variety of locations, days, and times. The investigators' program-MOVE OUT-may provide a model for VHA to use nationwide.

Conditions

Obesity; Overweight; Hypertension; Diabetes Mellitus

Keywords

Obesity; Veteran; Self Care; Patient Education; Peer Group

Outcome Measures

Primary Outcomes (1)

• Change in Weight (From Baseline)

  Weight as recorded in the medical record during a 6-month period around the follow-up point.

  Measured at 12 and 24 months

Study Arms (2)

Arm 1: MOVE OUT

EXPERIMENTAL

The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE! program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.

Behavioral: MOVE OUT

Arm 2: MOVE!

ACTIVE COMPARATOR

As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a "clinical reminder." This reminder prompts the primary care provider (PCP) to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.

Behavioral: MOVE!

Interventions

MOVE OUT BEHAVIORAL

The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.

Arm 1: MOVE OUT

MOVE! BEHAVIORAL

As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a "clinical reminder." This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.

Arm 2: MOVE!

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Visit to ZVAMC primary provider within 3 months
• BMI \>= 30 OR BMI \>= 25 and Hypertension or Diabetes Mellitus
• No scheduled appointment for a MOVE program clinic
• Age \<= 75 years
• Live in targeted geographic region

You may not qualify if:

• None

Sponsors & Collaborators

• VA Office of Research and Development: lead
• The American Legion Department of Wisconsin: collaborator
• Veterans Of Foreign Wars Of The United States Department Of Wisconsin: collaborator
• All Saints Catholic Church, Milwaukee: collaborator
• Three Holy Women Catholic Parish: collaborator
• Veterans 76 Ltd.: collaborator
• Dryhootch of America, Inc.: collaborator

Study Sites (1)

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, 53295-1000, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Because passive enrollment was allowed by our Institutional Review Board, we were able to enroll all eligible patients identified by our automated record review. However, very few of the veterans randomized to the intervention used the program.

Results Point of Contact

• Title: Dr. Jeff Whittle
• Organization: Clement J. Zablocki VA Medical Center

jeffrey.whittle@va.gov

(414) 384-2000

Study Officials

• Jeffrey C Whittle, MD MPH

  Clement J. Zablocki VA Medical Center, Milwaukee, WI

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: April 20, 2011
• Study Start: April 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 28, 2016
• Results First Posted: April 28, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)