Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03163264
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2017-05-19
Brief Title:
The Peer Assisted Lifestyle Intervention
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Testing the Efficacy of a Technology-assisted Intervention to Improve Weight Management of Obese Patients Within Patient Aligned Care Teams at the VA
Status:
COMPLETED
Status Verified Date:
2022-02
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:
PAL
Brief Summary:
The PAL intervention uses a new software tool delivered on tablets to facilitate 5As-based weight management counseling with a health coach and the VA PACT healthcare team to promote goal-setting behavior change and weight loss in the primary care PC setting The PAL intervention also includes 10-12 health-coaching calls to the patient over 12 months
As part of a cluster-randomized controlled study the investigators will randomize 17 PACT teams at the Brooklyn VA to receive either the PAL Intervention or an Enhanced Usual Care control The primary aim of the study is to explore differences in feasibility acceptability and intermediate behavioral and weight loss outcomes at 6 and 12 months of 520 patients recruited from the randomized PACTs
Objective
1 Explore the feasibility and impact of this intervention on intermediate behavioral and weight loss outcomes at 6 and 12 months post-intervention when compared to enhanced usual care
As part of a cluster-randomized controlled study the investigators will randomize 17 PACT teams at the Brooklyn VA to receive either the PAL Intervention or an Enhanced Usual Care control The primary aim of the study is to explore differences in feasibility acceptability and intermediate behavioral and weight loss outcomes at 6 and 12 months of 520 patients recruited from the randomized PACTs
Objective
1 Explore the feasibility and impact of this intervention on intermediate behavioral and weight loss outcomes at 6 and 12 months post-intervention when compared to enhanced usual care
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 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 The MOVE11 software is an expert system program for VA patients referred to MOVE but is not currently used in primary care by Patient-Aligned Care Teams PACT
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 The investigators formative work MIRB 01333 using key informant interviews with PACT teamlets and 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 the 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 PAL intervention uses the 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 10-12 health coaching calls over 1 year
As part of a clustered randomized control trial the investigators will randomize 17 PACT teams to either Enhanced Usual Care or the PAL Intervention recruiting 520 subjects
STUDY OBJECTIVES
Test the impact of the PAL intervention on weight change and behavioralclinical outcomes
Identify predictors of weight loss in Veterans participating in the intervention group related to goal setting processes and intervention components
Determine the impact of the PAL intervention on PACT 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 The MOVE11 software is an expert system program for VA patients referred to MOVE but is not currently used in primary care by Patient-Aligned Care Teams PACT
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 The investigators formative work MIRB 01333 using key informant interviews with PACT teamlets and 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 the 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 PAL intervention uses the 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 10-12 health coaching calls over 1 year
As part of a clustered randomized control trial the investigators will randomize 17 PACT teams to either Enhanced Usual Care or the PAL Intervention recruiting 520 subjects
STUDY OBJECTIVES
Test the impact of the PAL intervention on weight change and behavioralclinical outcomes
Identify predictors of weight loss in Veterans participating in the intervention group related to goal setting processes and intervention components
Determine the impact of the PAL intervention on PACT 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 |
|---|---|---|---|
| 01607 | OTHER_GRANT | Veterans Administration | None |