Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02626819
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2015-09-29
Brief Title:
Improving Weight Management at the VA
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Weight Management at VA Enhancing the MOVE23 for Primary Care CDA 10-206
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 36 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDA 10-206 | OTHER_GRANT | Veterans Administration | None |