Health TrialsbyHealthPanel

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

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years old or older

BMI ≥ 30

Speak either English or Spanish

Present at the participating clinic

Disqualifiers

Currently pregnant

Trial design

Design model

Sequential

Treatments tested in this trial

  • Ask-Advise-Connect (AAC)

    Behavioral

    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.

  • Text Messaging (TM)

    Behavioral

    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).

  • Connect Only (CO)

    Behavioral

    No patient level implementation strategy.

  • TM-Continued (TM-Cont)

    Behavioral

    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.

  • Continued TM plus Motivation And Problem Solving (TM+MAPS)

    Behavioral

    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.

Treatment groups

5,354 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: AAC OnlyOther 1 intervention
Group B: AAC + COOther 2 interventions
Group C: AAC + TMOther 2 interventions
Group D: AAC + TM + TM-ContOther 3 interventions
Group E: AAC + TM + TM+MAPSOther 3 interventions
Group F: Usual Care OnlyNo intervention 0 interventions

Trial outcomes

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.

Time frame
up to 12 months

Secondary outcomes

1

Reach-Offer

This outcome measure will report Reach-Offer, defined as the number of eligible clinical encounters in which AAC is performed, divided by the total number of eligible encounters.

Time frame
up to 9 months
2

Reach-Connect

This outcome measure will report Reach-Connect, defined as the number of eligible individuals who accept connection to the EBI divided by the total number of individuals offered connection via AAC or patient implementation strategies.

Time frame
up to 1 year
3

Representativeness

This outcome measure will report Representativeness, defined as the demographics of participants compared to the CHC patient population.

Time frame
up to 9 months
4

Adherence to the EBI

To assess EBI effectiveness for 12 months following EBI enrollment. This outcome measure will report patient adherence, defined as the number of participants who complete the EBI divided by the number of participants who enroll in the EBI.

Time frame
up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Association for Utah Community Health

Collaborator

Source ClinicalTrials.gov
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