The Fit With Us Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Alabama at Birmingham

About this trial

The purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one-on-one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre-recorded exercise content and articles for a 24-week maintenance phase (weeks 9-32). The study outcomes are: The effectiveness of the adaptive interventions; Exploring mediating and moderating variables; Sensitivity analysis of the predictive analytics.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Factorial

Treatments tested in this trial

  • asynchronous content only

    Behavioral

    Receives asynchronous exercise content and no live training

  • Asynchronous content and health coaching and no live training

    Behavioral

    Receives asynchronous content, health coaching and no live training.

  • asynchronous content only and 1 on 1 live training

    Behavioral

    receives asynchronous content and live 1 on 1 training

  • asynchronous content and health coaching and 1 on 1 training

    Behavioral

    receives asynchronous content, health coaching, and live training

  • asynchronous content and group training

    Behavioral

    receives asynchronous content and live group training

  • Asynchronous content and health coaching and group training

    Behavioral

    receives asynchronous content, health coaching, and live group training

Treatment groups

257 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: asynchronous exercise responderExperimental treatment 1 intervention
Group B: Asynchronous exercise and health coaching responderExperimental treatment 1 intervention
Group C: Asynchronous exercise non-responder and 1 on 1 live trainingExperimental treatment 1 intervention
Group D: Asynchronous exercise and health coaching non-responder and 1 on 1 live trainingExperimental treatment 1 intervention
Group E: Asynchronous exercise non-responder and group live trainingExperimental treatment 1 intervention
Group F: Asynchronous exercise and health coaching non-responder and group live trainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Physical activity

The primary outcome is the change in physical activity (steps per day) from baseline to the end of the 32-week intervention. Participants wear Fitbit Inspire 3 trackers (Google LLC, Sacramento, CA) for continuous objective measurement, with data exported via the study dashboard. This is supplemented by the Godin Leisure-Time Exercise Questionnaire (GLETQ) at baseline, week-8 and week-16 for self-reported leisure-time activity in MET-minutes/week.

Time frame
Fitbit: ongoing for 32 weeks; Godin: Baseline, week 8, week 16, and week 32

Secondary outcomes

1

Health information technology literacy

The secondary outcome is health information technology literacy, measured by the eHealth Literacy Scale (eHEALS). The eHEALS is a validated 8-item questionnaire assessing participants' perceived skills in finding, evaluating, and applying online health information (scored 8-40). Assessments occur at baseline, week 8, week 16, and week 32 to track changes over the 32-week intervention.

Time frame
Baseline, week 8, week 16, and week 32
2

Secondary Health Conditions

The secondary outcome is secondary health conditions, assessed via National Institutes of Health Patient-Reported Outcome Measurement Information System (PROMIS) questionnaires. PROMIS measures include pain interference, fatigue, sleep disturbance, and quality of life, each on a T-score metric (mean 50, SD 10) for standardized comparison. Assessments occur at baseline, week 8, week 16, and week 32 to evaluate changes over the 32-week intervention.

Time frame
Baseline, week 8, week 16, and week 32
3

Activity limitations

The secondary outcome is activity limitations, measured by the Physical Functioning subscale of the 36-Item Short Form Survey (SF-36 PF). The SF-36 PF is a validated 10-item questionnaire assessing limitations in physical activities due to health problems (scored 0-100, higher scores indicate better functioning). Assessments occur at baseline, week 8, week 16, and week 32 to track changes over the 32-week intervention.

Time frame
Baseline, week 8, week 16, and week 32

Other outcomes

Sponsors and contacts

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