Trial Outcomes & Findings for MOVE OUT: A Partnership With Veterans Groups to Enhance Weight Management in the Veterans Health Administration (VHA) (NCT NCT01339390)

NCT ID: NCT01339390

Last Updated: 2016-04-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3169 participants
• Primary outcome timeframe: Measured at 12 and 24 months
• Results posted on: 2016-04-28

Participant Flow

Participant milestones

Measure	Arm 1: MOVE OUT 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. MOVE OUT: 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 2: MOVE! As part of routine care, all patients who are eligible for the present study are identified by a "clinical reminder." This 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 patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs. MOVE!: As part of routine care, 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.
Overall Study STARTED	1571	1598
Overall Study COMPLETED	1414	1442
Overall Study NOT COMPLETED	157	156

Reasons for withdrawal

Measure	Arm 1: MOVE OUT 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. MOVE OUT: 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 2: MOVE! As part of routine care, all patients who are eligible for the present study are identified by a "clinical reminder." This 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 patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs. MOVE!: As part of routine care, 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.
Overall Study Death	32	29
Overall Study Lost to Follow-up	125	127

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm 1: MOVE OUT n=1571 Participants 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. MOVE OUT: 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 2: MOVE! n=1598 Participants 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. MOVE!: 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.	Total n=3169 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1021 Participants n=5 Participants	1028 Participants n=7 Participants	2049 Participants n=5 Participants
Age, Categorical >=65 years	550 Participants n=5 Participants	570 Participants n=7 Participants	1120 Participants n=5 Participants
Age, Continuous	59.26 years STANDARD_DEVIATION 10.8 • n=5 Participants	59.80 years STANDARD_DEVIATION 10.4 • n=7 Participants	59.54 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	54 Participants n=7 Participants	120 Participants n=5 Participants
Sex: Female, Male Male	1505 Participants n=5 Participants	1544 Participants n=7 Participants	3049 Participants n=5 Participants
Region of Enrollment United States	1571 participants n=5 Participants	1598 participants n=7 Participants	3169 participants n=5 Participants
Weight	230.16 pounds STANDARD_DEVIATION 43.82 • n=5 Participants	229.01 pounds STANDARD_DEVIATION 42.74 • n=7 Participants	229.58 pounds STANDARD_DEVIATION 43.28 • n=5 Participants

PRIMARY outcome

Timeframe: Measured at 12 and 24 months

Population: For the analysis, we included those lost to follow up by using the last observation carried forward to impute missing values

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

Outcome measures

Measure	Arm 1: MOVE OUT n=1571 Participants 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. MOVE OUT: 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 2: MOVE! n=1598 Participants 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. MOVE!: 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.
Change in Weight (From Baseline) 24 months	-1.64 Pounds Standard Deviation 15.34	-1.06 Pounds Standard Deviation 15.22
Change in Weight (From Baseline) 12 months	-0.71 Pounds Standard Deviation 12.04	-0.31 Pounds Standard Deviation 12.49

Adverse Events

Arm 1: MOVE OUT

Serious events: 32 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: MOVE!

Serious events: 29 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1: MOVE OUT n=1571 participants at risk 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. MOVE OUT: 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 2: MOVE! n=1598 participants at risk 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. MOVE!: 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.
General disorders Death at 12 months	0.45% 7/1571 • For each cohort, we followed them passively for two years. This was done using only the electronic health record. We made no provision for identifying specific adverse events, but did record mortality. this was identified using the VA mortality data.	0.38% 6/1598 • For each cohort, we followed them passively for two years. This was done using only the electronic health record. We made no provision for identifying specific adverse events, but did record mortality. this was identified using the VA mortality data.
General disorders Death at 24 months	1.6% 25/1571 • For each cohort, we followed them passively for two years. This was done using only the electronic health record. We made no provision for identifying specific adverse events, but did record mortality. this was identified using the VA mortality data.	1.4% 23/1598 • For each cohort, we followed them passively for two years. This was done using only the electronic health record. We made no provision for identifying specific adverse events, but did record mortality. this was identified using the VA mortality data.

Other adverse events

Measure	Arm 1: MOVE OUT n=1571 participants at risk 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. MOVE OUT: 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 2: MOVE! n=1598 participants at risk 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. MOVE!: 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.
General disorders All others	— 0/0 • For each cohort, we followed them passively for two years. This was done using only the electronic health record. We made no provision for identifying specific adverse events, but did record mortality. this was identified using the VA mortality data.	— 0/0 • For each cohort, we followed them passively for two years. This was done using only the electronic health record. We made no provision for identifying specific adverse events, but did record mortality. this was identified using the VA mortality data.

Additional Information

Dr. Jeff Whittle

Clement J. Zablocki VA Medical Center

Phone: (414) 384-2000

Email: jeffrey.whittle@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place