Partnership to Reduce Obesity in Community Health Center Patients (SMARTLife Utah)

Utah System of Higher Education (USHE)

Status: Not yet enrolling

Conditions: Obesity

Treatments: Behavioral: Ask-Advise-Connect (AAC); Behavioral: Continued TM plus Motivation And Problem Solving (TM+MAPS); Behavioral: Text Messaging (TM); Behavioral: TM-Continued (TM-Cont); Behavioral: Connect Only (CO)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07582016

HCI184365

5R01CA283950-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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:

1. a clinic-level HIT implementation strategy that includes enhanced system supports at the point of care; and
2. patient-level implementation strategies that provide repeated opportunities to enroll in EBIs, as well as motivation/practical problem-solving to facilitate enrollment.

Full 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:

1. a clinic-level HIT implementation strategy that includes enhanced system supports at the point of care; and,
2. 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:

1. Evidence that EBIs for obesity are effective but underutilized,
2. Recommendations to scale up EBI reach and reduce inequities utilizing technology-based programs,
3. Data demonstrating that HIT implementation strategies can dramatically increase engagement with EBIs and fit within existing clinical systems,
4. Data indicating that text messaging can increase the reach of EBIs, and
5. Prior research has highlighted the effectiveness of telehealth-based patient navigation in improving the reach of EBIs.

SMARTLife Utah will provide critical data regarding the impact of pragmatic and scalable multilevel implementation strategies designed to increase the uptake of EBIs for obesity among patients of CHCs. It will also advance the field of dissemination and implementation science by testing key constructs hypothesized to influence implementation and effectiveness using a comprehensive conceptual framework.

Enrollment: 5,354 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old or older
• BMI ≥ 30
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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5,354 participants in 6 patient groups

AAC Only

Other group

Description:

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.

Treatment:

Behavioral: Ask-Advise-Connect (AAC)

AAC + CO

Other group

Description:

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.

Treatment:

Behavioral: Connect Only (CO)

Behavioral: Ask-Advise-Connect (AAC)

AAC + TM

Other group

Description:

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).

Treatment:

Behavioral: Text Messaging (TM)

Behavioral: Ask-Advise-Connect (AAC)

AAC + TM + TM-Cont

Other group

Description:

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).

Treatment:

Behavioral: TM-Continued (TM-Cont)

Behavioral: Text Messaging (TM)

Behavioral: Ask-Advise-Connect (AAC)

AAC + TM + TM+MAPS

Other group

Description:

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).

Treatment:

Behavioral: Text Messaging (TM)

Behavioral: Continued TM plus Motivation And Problem Solving (TM+MAPS)

Behavioral: Ask-Advise-Connect (AAC)

Usual Care Only

No Intervention group

Description:

No patient level implementation strategy.