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

Overview

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.

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:

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.

Interventions

• Behavioral Ask-Advise-Connect (AAC)
  A Health Information Technology (HIT) intervention that consists of an Electronic Health Record (EHR)-based point of care assessment of height/weight for BMI (ASK). If BMI ≥ 30, clinic staff are prompted to ADVISE via a standardized script and automatically CONNECT interested patients to the Evidence-Based Interventions (EBIs) through electronic referral.
• Behavioral Text Messaging (TM)
  Bidirectional text messages, which include a simple response that directly connects individuals to the EBI in a variety of ways (phone, website, or callback from EBI).
• Behavioral Connect Only (CO)
  No patient level implementation strategy.
• Behavioral TM-Continued (TM-Cont)
  Bidirectional text messages, which include a simple one-touch response that directly connects individuals to the EBI in a variety of ways (phone, website, or callback from EBI). No additional patient-level implementation strategy.
• Behavioral Continued TM plus Motivation And Problem Solving (TM+MAPS)
  Text messages plus telephone health coach calls. MAPS is an empirically validated behavioral approach that has been demonstrated to facilitate change, including enrollment with EBIs.

Primary outcome measures

• Reach-Enroll [Time frame: up to 12 months]

Secondary outcome measures (5)

• Reach-Offer [Time frame: up to 9 months]
• Reach-Connect [Time frame: up to 1 year]
• Representativeness [Time frame: up to 9 months]
• Adherence to the EBI [Time frame: up to 1 year]
• Weight Loss [Time frame: up to 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Huntsman Cancer Institute at the University of Utah — Salt Lake City

Identifiers

NCT: NCT07582016 · 184365 · 5R01CA283950-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗