Partnership to Reduce Obesity in Community Health Center Patients (SMARTLife Utah)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Utah
- Enrollment
- 5,354
- Locations
- 1
- Primary Endpoint
- Reach-Enroll
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Currently pregnant
Arms & Interventions
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.
Intervention: 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).
Intervention: 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).
Intervention: Text Messaging (TM) (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.
Intervention: 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).
Intervention: 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).
Intervention: 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).
Intervention: 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).
Intervention: 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).
Intervention: 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).
Intervention: 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.
Intervention: Ask-Advise-Connect (AAC) (Behavioral)
Usual Care Only
No patient level implementation strategy.
Outcomes
Primary Outcomes
Reach-Enroll
Time Frame: up to 12 months
This outcome measure will report Reach-Enroll, defined as the number of eligible patients who officially enroll in the EBI divided by the total number of eligible patients. Patients are eligible if they are ≥ 18 years, have a clinic visit during the AAC implementation period, and have a BMI ≥ 30.
Secondary Outcomes
- Reach-Offer(up to 9 months)
- Reach-Connect(up to 1 year)
- Representativeness(up to 9 months)
- Adherence to the EBI(up to 1 year)
- Weight Loss(up to 1 year)