WOOP VA: Mental Contrasting With Implementation Intentions to Promote Weight Management in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 405
- 试验地点
- 2
- 主要终点
- Mean Percent Weight Change
研究概览
简要总结
Approximately 40% of Veterans have obesity and are at increased risk for cardiometabolic disease. Intensive lifestyle-based weight management programs can lead to clinically significant ( 5%) weight loss. The VA's MOVE! program is effective for promoting weight loss and behavior change for those who attend. Unfortunately, MOVE! has low enrollment and high attrition due to several obstacles including low motivation. Mental Contrasting with Implementation Intentions (MCII) is an innovative strategy developed over 20 years of research that uses imagery to increase motivation for behavior change. MCII can be implemented in primary care settings using an easy to teach technique called "WOOP" (Wish, Outcome, Obstacle, Plan) that Veterans then use regularly on their own with the help of paper-based tools or the WOOP app. The research team will evaluate the efficacy and implementation of MCII when combined with telephone-delivered MOVE! vs. telephone-delivered MOVE! alone to enhance weight management outcomes for Veterans in primary care.
详细描述
Background: Approximately 40% of Veterans have obesity. Intensive weight management programs such as MOVE! promote clinically significant weight loss, but only 3-7% of eligible Veterans attend. Low enrollment and high attrition are due to obstacles such as travel, cost, and motivation. Developed through over 20 years of research, Mental Contrasting with Implementation Intentions (MCII) is a novel, evidence-based intervention to increase motivation and behavior change. MCII has been shown to increase physical activity and consumption of fruits and vegetables and promote weight loss, and the research team recently demonstrated that MCII is feasible and acceptable to Veterans for weight management. However, has not been tested adequately within primary care nor demonstrated weight loss in Veterans. The investigators propose to evaluate the efficacy and implementation of MCII for behavior change and weight loss in Veterans within primary care when combined with the VA MOVE! Program.
Significance/Impact: This proposal aligns with the VA HSRD "primary care practice and management of complex chronic diseases" funding priority. Primary care providers and PACT members do not provide sufficient counseling to increase engagement with the MOVE! Program. MCII can be taught by lay educators and can be delivered in conjunction with MOVE! and other weight management treatments.
Innovation: MCII is innovative in its use of imagery, ease of delivery by lay educators, novel mechanisms of action (via non-conscious motivational and cognitive processes), and ability to be combined with other programs. Veterans can practice MCII on their own in under 10 minutes. MCII uses a standardized, 4-step imagery procedure called WOOP that can be taught in 30 minutes. Veterans can then continue to use WOOP regularly, with the assistance of a WOOP App and website containing video-, audio-, and paper-based tools. This study will be the first randomized controlled trial of MCII within primary care and the first RCT to test the efficacy and implementation of MCII for weight management when combined with MOVE! in Veterans.
Specific Aims: 1. Compare the impact of MCII + MOVE!/TeleMOVE! vs. MOVE!/TeleMOVE! alone on percent weight change and waist circumference at 6 and 12 months. 2. Compare the impact of MCII + MOVE!/TeleMOVE! vs. MOVE!/TeleMOVE! alone on MOVE!/TeleMOVE! program attendance, healthy eating, and physical activity at 6 and 12 months. 3. Evaluate implementation of MCII. The investigators will use the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to evaluate implementation barriers, facilitators, and outcomes of MCII.
Methodology: The investigators will enroll 405 Veterans and randomize 366 Veterans at the patient level within primary care to either MCII + telephone-delivered MOVE!/TeleMOVE! (intervention) vs. telephone-delivered MOVE!/TeleMOVE! alone (control) at the Manhattan VA. At 6 and 12 months, participants will return to the clinic for a study visit where weight, diet, and physical activity will be assessed in both groups. The investigators will use intention-to-treat analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study staff, investigators, and outcome assessors will be blinded to the intervention arm. The lay health coach interventionist and the participant will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-70 (this age range represents MOVE!/TeleMOVE! eligibility);
- •The most recent BMI of 30kg/m2 (with or without obesity-associated comorbidities) OR a BMI of 25kg/m2 with obesity-associated condition (heart diseases, hyperlipidemia, hypertension, cancer, diabetes, stroke, or osteoarthritis);
- •at least 1 prior PCP visit in the past 24 months; access to a telephone; ability to travel to Manhattan VA for in-person evaluations at baseline, 6 and 12 months;
- •desire to lose weight (Using 1-10 scale used in PI's other studies; minimum of 5/10);
- •willingness to enroll in the MOVE!/TeleMOVE! program or any local/national VA program that support weight management.
排除标准
- •Non-Veterans;
- •a documented current history of active psychosis or other cognitive issues via ICD-10 codes;
- •Diagnosed with Parkinson's disease and/or severe arthritis that might require joint or knee replacement in the next year;
- •participating in a weight management study in the past year;
- •taking an FDA-approved weight loss medication; Bupropion-naltrexone (Contrave) Liraglutide (Saxenda) Orlistat (Xenical)/alli Phentermine-topiramate (Qsymia) Phentermine Topiramate Lorcaserin / Belviq glucagon-like peptide 1 (GLP-1) agonists:
- •Diabetes drugs in the GLP-1 agonists class include:
- •Dulaglutide (Trulicity) Exenatide extended release (Bydureon) Exenatide (Byetta) Semaglutide (Ozempic) Semaglutide (Rybelsus) Liraglutide (Victoza) Lixisenatide (Adlyxin) Metformin to lose weight not for your diabetes;
- •pregnancy;
- •PCP stating that Veteran should not participate.
- •Seeing a dietitian or MOVE!/TeleMOVE! Program attendance more than 3 times in the past year.
- •Hospitalization within 90 days of enrollment.
- •Anyone who is included in Dr. Jose Aleman weight management clinic
研究组 & 干预措施
Telephone Delivered MOVE!/TeleMOVE!
During the baseline visit, Veterans randomized to the control arm will receive only the standard information about MOVE!/TeleMOVE!, diet, and physical activity delivered by the same lay educators. They will not learn the WOOP technique as detailed below. Data collection during study visits will be at the same timepoints in both arms.
干预措施: Information About Diet, Physical Activity, and Weight Management (Baseline Visit - 10 minutes): All (Behavioral)
Telephone Delivered MOVE!/TeleMOVE!
During the baseline visit, Veterans randomized to the control arm will receive only the standard information about MOVE!/TeleMOVE!, diet, and physical activity delivered by the same lay educators. They will not learn the WOOP technique as detailed below. Data collection during study visits will be at the same timepoints in both arms.
干预措施: telephone-delivered, telehealth-delivered, and or in-person MOVE! or TeleMOVE! (Behavioral)
Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE!
At the baseline visit, a lay educator will teach the WOOP technique in-person using protocols adapted from our prior work. After, to support WOOP practice, the lay educator will schedule and provide 3 follow-up telephone check-ins with the Veteran. This arm will also receive telephone-delivered MOVE!/TeleMOVE!
干预措施: mental contrasting with implementation intentions (Behavioral)
Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE!
At the baseline visit, a lay educator will teach the WOOP technique in-person using protocols adapted from our prior work. After, to support WOOP practice, the lay educator will schedule and provide 3 follow-up telephone check-ins with the Veteran. This arm will also receive telephone-delivered MOVE!/TeleMOVE!
干预措施: telephone-delivered, telehealth-delivered, and or in-person MOVE! or TeleMOVE! (Behavioral)
Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE!
At the baseline visit, a lay educator will teach the WOOP technique in-person using protocols adapted from our prior work. After, to support WOOP practice, the lay educator will schedule and provide 3 follow-up telephone check-ins with the Veteran. This arm will also receive telephone-delivered MOVE!/TeleMOVE!
干预措施: Information About Diet, Physical Activity, and Weight Management (Baseline Visit - 10 minutes): All (Behavioral)
Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE!
At the baseline visit, a lay educator will teach the WOOP technique in-person using protocols adapted from our prior work. After, to support WOOP practice, the lay educator will schedule and provide 3 follow-up telephone check-ins with the Veteran. This arm will also receive telephone-delivered MOVE!/TeleMOVE!
干预措施: Telephone MCII Check-ins (30 minutes at 3 days, 4 weeks, and 2 months after baseline visit) (Behavioral)
结局指标
主要结局
Mean Percent Weight Change
时间窗: 6 months
The research team will measure weight using a standardized protocol, taking the average of 2 weights in pounds, rounded to the nearest 0.1lb.
次要结局
- Mean Percent Weight Change(12 month)
- Waist Circumference change(6 and 12 months)
- Healthy Eating Index change(baseline, 6 and 12 months)
- Physical Activity--Weekly minutes of Moderate to Vigorous Physical Activity (MVPA)(Baseline, 6 and 12 months)
- MOVE! Attendance change(Baseline, 6 and 12 months)
- Change in Self Reported Physical Activity(Baseline, 6 and 12 months)