Partnership to Reduce Obesity in Community Health Center Patients (SMARTLife Utah)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,354
- 试验地点
- 1
研究概览
简要总结
The long-term objective of SMARTLife Utah is to increase the reach of existing digital EBIs for obesity among patients of Community Health Centers (CHCs). SMARTLife Utah will be conducted in up to 11 Community Health Center (CHC) systems, consisting of 38 primary care clinics. SMARTLife Utah is a hybrid Type III effectiveness-implementation design, utilizing a pragmatic, multilevel, three-phase Sequential Multiple Assignment Randomized Trial (SMART). SMARTLife Utah leverages ubiquitous health information technology(HIT)/telehealth for both the implementation strategies and Evidence-Based Intervention (EBI) delivery in order to address barriers for engaging in EBIs.
Implementation strategies target two different levels to increase the reach of EBIs:
- a clinic-level HIT implementation strategy that includes enhanced system supports at the point of care; and
- patient-level implementation strategies that provide repeated opportunities to enroll in EBIs, as well as motivation/practical problem-solving to facilitate enrollment.
详细描述
Approximately 40% of U.S. adults have obesity (BMI>30), and excess body weight is associated with at least 13 different cancers and 5% and 11% of cancer cases in men and women, respectively. Evidence-Based Interventions (EBIs) that address excess body weight, physical inactivity, and poor diet are effective in promoting weight loss and reducing cancer risk, but are grossly underutilized. Digital EBI delivery modalities have yielded outcomes comparable to in-person programs. As such, the long-term objective of SMARTLife Utah is to increase the reach of existing digital EBIs for obesity among patients of Community Health Centers (CHCs).
SMARTLife Utah will be conducted in up to 11 Community Health Center (CHC) systems, consisting of 38 primary care clinics. SMARTLife Utah is a hybrid type III effectiveness - implementation design, using a pragmatic, multilevel, three-phase, Sequential Multiple Assignment Randomized Trial (SMART). SMARTLife Utah leverages ubiquitous health information technology (HIT)/telehealth for both the implementation strategies and EBI delivery in order to address barriers of engaging in EBIs.
Implementation strategies target two different levels to increase the reach of EBIs:
- a clinic-level HIT implementation strategy that includes enhanced system supports at the point of care; and,
- patient-level implementation strategies that provide repeated opportunities to enroll in EBIs, as well as motivation/practical problem-solving to facilitate enrollment.
The scientific premise of SMARTLife Utah is based on:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Speak either English or Spanish
- •Present at the participating clinic
- •Valid cell phone number in the electronic health record (EHR)
- •EHR indicates they have not opted out of receiving text messages from the clinic
排除标准
- •Currently pregnant
研究组 & 干预措施
AAC + CO
AAC will be implemented across all clinics and evaluated using a stepped wedge design.
CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period.
CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation.
CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation.
A Clinic-level implementation strategy only (CO) for the 12 months following each individual's clinic visit.
干预措施: Ask-Advise-Connect (AAC) (Behavioral)
AAC + TM + TM-Cont
AAC will be implemented across all clinics and evaluated using a stepped wedge design.
CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period.
CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation.
CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation.
TM consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (i.e., up to 6 texts in all).
TM Continued (TM-Cont) will consist of a monthly text message that includes a simple one-touch response to connect during months 6-12 following each individual's clinic visit (i.e., up to 6 texts).
干预措施: Ask-Advise-Connect (AAC) (Behavioral)
AAC + TM + TM-Cont
AAC will be implemented across all clinics and evaluated using a stepped wedge design.
CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period.
CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation.
CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation.
TM consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (i.e., up to 6 texts in all).
TM Continued (TM-Cont) will consist of a monthly text message that includes a simple one-touch response to connect during months 6-12 following each individual's clinic visit (i.e., up to 6 texts).
干预措施: Text Messaging (TM) (Behavioral)
AAC + TM + TM-Cont
AAC will be implemented across all clinics and evaluated using a stepped wedge design.
CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period.
CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation.
CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation.
TM consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (i.e., up to 6 texts in all).
TM Continued (TM-Cont) will consist of a monthly text message that includes a simple one-touch response to connect during months 6-12 following each individual's clinic visit (i.e., up to 6 texts).
干预措施: TM-Continued (TM-Cont) (Behavioral)
AAC + TM + TM+MAPS
AAC will be implemented across all clinics and evaluated using a stepped wedge design.
CHCs randomized to Wedge 1 will continue with UC for 3 months, then AAC for 9 months during the SW Evaluation period.
CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation.
CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation.
TM consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (up to 6 texts).
Continued TM plus Motivation And Problem Solving (TM+MAPS) will consist of a monthly text message plus up to 2 brief telephone calls from patient navigators during months 6-12 following each individual's clinic visit (up to 6 texts and 2 calls).
干预措施: Ask-Advise-Connect (AAC) (Behavioral)
AAC + TM + TM+MAPS
AAC will be implemented across all clinics and evaluated using a stepped wedge design.
CHCs randomized to Wedge 1 will continue with UC for 3 months, then AAC for 9 months during the SW Evaluation period.
CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation.
CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation.
TM consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (up to 6 texts).
Continued TM plus Motivation And Problem Solving (TM+MAPS) will consist of a monthly text message plus up to 2 brief telephone calls from patient navigators during months 6-12 following each individual's clinic visit (up to 6 texts and 2 calls).
干预措施: Text Messaging (TM) (Behavioral)
AAC + TM + TM+MAPS
AAC will be implemented across all clinics and evaluated using a stepped wedge design.
CHCs randomized to Wedge 1 will continue with UC for 3 months, then AAC for 9 months during the SW Evaluation period.
CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation.
CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation.
TM consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (up to 6 texts).
Continued TM plus Motivation And Problem Solving (TM+MAPS) will consist of a monthly text message plus up to 2 brief telephone calls from patient navigators during months 6-12 following each individual's clinic visit (up to 6 texts and 2 calls).
干预措施: Continued TM plus Motivation And Problem Solving (TM+MAPS) (Behavioral)
AAC Only
Ask-Advise-Connect (AAC) will be implemented across all clinics and evaluated using a stepped wedge design.
CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period.
CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation.
CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation.
干预措施: Ask-Advise-Connect (AAC) (Behavioral)
AAC + CO
AAC will be implemented across all clinics and evaluated using a stepped wedge design.
CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period.
CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation.
CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation.
A Clinic-level implementation strategy only (CO) for the 12 months following each individual's clinic visit.
干预措施: Connect Only (CO) (Behavioral)
AAC + TM
AAC will be implemented across all clinics and evaluated using a stepped wedge design.
CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period.
CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation.
CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation.
Text Messaging (TM) consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (i.e., up to 6 texts in all).
干预措施: Ask-Advise-Connect (AAC) (Behavioral)
AAC + TM
AAC will be implemented across all clinics and evaluated using a stepped wedge design.
CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period.
CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation.
CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation.
Text Messaging (TM) consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (i.e., up to 6 texts in all).
干预措施: Text Messaging (TM) (Behavioral)
Usual Care Only
No patient level implementation strategy.