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临床试验/NCT03163264
NCT03163264已完成不适用

Testing the Efficacy of a Technology-assisted Intervention to Improve Weight Management of Obese Patients Within Patient Aligned Care Teams at the VA

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2018年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
301
试验地点
1
主要终点
Mean Weight Change in Kg

研究概览

简要总结

The PAL intervention uses a new software tool delivered on tablets to facilitate 5As-based weight management counseling with a peer 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 primary care providers 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 primary care providers.

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.

详细描述

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 3.6 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 MOVE!11 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 primary care providers to either Enhanced Usual Care or the PAL Intervention, recruiting 520 subjects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-69 (this age range represents MOVE! eligibility)
  • •BMI of 30kg/m2 or a BMI of 25kg/m2 with obesity-associated condition
  • •Under the care of PCP with at least 1 prior visit with the provider in the past 24 months
  • •Access to a telephone
  • •Able to travel to Brooklyn VA for in-person evaluations at baseline, 6, and 12 months

排除标准

  • •Non-Veterans
  • •A documented current history of active psychosis, active bipolar disorder, or other cognitive issues via ICD-10 codes
  • •Undergoing insulin-therapy for diabetes
  • •Self-reported inability to read at a 5th grade level due to literacy level or vision problems
  • •Has attended more than 4 MOVE! sessions in the past year
  • •Pregnancy
  • •PCP stating that Veteran should not participate

研究组 & 干预措施

PAL Intervention

Experimental

Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity

Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider)

干预措施: Peer Assisted Lifestyle (Behavioral)

Enhanced Usual Care (EUC)

Active Comparator

Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity

干预措施: Enhanced Usual Care (Behavioral)

结局指标

主要结局

Mean Weight Change in Kg

时间窗: 12 months

Weight change in kg at 12 months

Mean Percent Weight Change From Baseline to 12 Months

时间窗: 12 months

Mann-Whitney tests for continuous outcomes (e.g., weight change)

次要结局

  • Achievement of 5% Weight Loss(12 months)
  • Changes in HB A1C(6 and 12 months)
  • Changes in Waist Circumference(12 months)
  • Changes in Physical Activity(6 and 12 months)
  • Moderate to Vigorous Physical Activity Difference (Minutes)(12 months)
  • Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week(12 months)
  • Achievement of 5% Weight Loss(6 months)
  • Changes in Waist Circumference(6 months)
  • Moderate to Vigorous Physical Activity Difference (Minutes)(6 months)
  • Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week(6 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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