Partnership to Reduce Obesity in Community Health Center Patients (SMARTLife Utah)
2 other identifiers
interventional
5,354
1 country
1
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Apr 2026
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
May 5, 2026
CompletedFirst Posted
Study publicly available on registry
May 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
May 14, 2026
May 1, 2026
3 years
May 5, 2026
May 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Reach-Enroll
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.
up to 12 months
Secondary Outcomes (5)
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
Study Arms (6)
AAC Only
OTHERAsk-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.
AAC + CO
OTHERAAC 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.
AAC + TM
OTHERAAC 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).
AAC + TM + TM-Cont
OTHERAAC 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).
AAC + TM + TM+MAPS
OTHERAAC 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).
Usual Care Only
NO INTERVENTIONNo patient level implementation strategy.
Interventions
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.
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).
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Currently pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- National Cancer Institute (NCI)collaborator
- Association for Utah Community Health (AUCH)collaborator
Study Sites (1)
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chelsey Schlechter, PhD
Huntsman Cancer Institute/ University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2026
First Posted
May 12, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
May 14, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share