Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial
Introduction Over 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/11/e075157.full |
| _version_ | 1797430537840754688 |
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| author | David W Wetter Guilherme Del Fiol Inbal Nahum-Shani Dusti R Jones Bryan Gibson Ellen Maxfield Chelsey R Schlechter Brian Orleans Amy Locke Ryan Cornia Richard Bradshaw Jennifer Wirth Shanna J Jaggers Cho Y Lam |
| author_facet | David W Wetter Guilherme Del Fiol Inbal Nahum-Shani Dusti R Jones Bryan Gibson Ellen Maxfield Chelsey R Schlechter Brian Orleans Amy Locke Ryan Cornia Richard Bradshaw Jennifer Wirth Shanna J Jaggers Cho Y Lam |
| author_sort | David W Wetter |
| collection | DOAJ |
| description | Introduction Over 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs) for weight management exist but reach less than 3% of eligible individuals. The aims of this pilot randomised controlled trial are to evaluate feasibility and acceptability of dissemination strategies designed to increase reach of EBIs for weight management.Methods and analysis This study is a two-phase, Sequential Multiple Assignment Randomized Trial, conducted with 200 Medicaid patients. In phase 1, patients will be individually randomised to single text message (TM1) or multiple text messages (TM+). Phase 2 is based on treatment response. Patients who enrol in the EBI within 12 weeks of exposure to phase 1 (ie, responders) receive no further interventions. Patients in TM1 who do not enrol in the EBI within 12 weeks of exposure (ie, TM1 non-responders) will be randomised to either TM1-Continued (ie, no further TM) or TM1 & MAPS (ie, no further TM, up to 2 Motivation And Problem Solving (MAPS) navigation calls) over the next 12 weeks. Patients in TM+ who do not enrol in the EBI (ie, TM+ non-responders) will be randomised to either TM+Continued (ie, monthly text messages) or TM+ & MAPS (ie, monthly text messages, plus up to 2 MAPS calls) over the next 12 weeks. Descriptive statistics will be used to characterise feasibility (eg, proportion of patients eligible, contacted and enrolled in the trial) and acceptability (eg, participant opt-out, participant engagement with dissemination strategies, EBI reach (ie, the proportion of participants who enrol in EBI), adherence, effectiveness).Ethics and dissemination Study protocol was approved by the University of Utah Institutional Review Board (#00139694). Results will be disseminated through study partners and peer-reviewed publications.Trial registration number clinicaltrials.gov; NCT05666323. |
| first_indexed | 2024-03-09T09:29:02Z |
| format | Article |
| id | doaj.art-72f34fc4af484c73a8a8c32b15cf2534 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-09T09:29:02Z |
| publishDate | 2023-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-72f34fc4af484c73a8a8c32b15cf25342023-12-02T04:50:13ZengBMJ Publishing GroupBMJ Open2044-60552023-11-01131110.1136/bmjopen-2023-075157Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised TrialDavid W Wetter0Guilherme Del Fiol1Inbal Nahum-Shani2Dusti R Jones3Bryan Gibson4Ellen Maxfield5Chelsey R Schlechter6Brian Orleans7Amy Locke8Ryan Cornia9Richard Bradshaw10Jennifer Wirth11Shanna J Jaggers12Cho Y Lam13Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USADepartment of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USAInstitute for Social Research, University of Michigan, Ann Arbor, Michigan, USADepartment of Population Health Sciences, University of Utah, Salt Lake City, Utah, USADepartment of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USAOsher Center for Integrative Health, University of Utah, Salt Lake City, Utah, USAHuntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USAHuntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USAOsher Center for Integrative Health, University of Utah, Salt Lake City, Utah, USADepartment of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USADepartment of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USAHuntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USAHuntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USADepartment of Population Health Sciences, University of Utah, Salt Lake City, Utah, USAIntroduction Over 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs) for weight management exist but reach less than 3% of eligible individuals. The aims of this pilot randomised controlled trial are to evaluate feasibility and acceptability of dissemination strategies designed to increase reach of EBIs for weight management.Methods and analysis This study is a two-phase, Sequential Multiple Assignment Randomized Trial, conducted with 200 Medicaid patients. In phase 1, patients will be individually randomised to single text message (TM1) or multiple text messages (TM+). Phase 2 is based on treatment response. Patients who enrol in the EBI within 12 weeks of exposure to phase 1 (ie, responders) receive no further interventions. Patients in TM1 who do not enrol in the EBI within 12 weeks of exposure (ie, TM1 non-responders) will be randomised to either TM1-Continued (ie, no further TM) or TM1 & MAPS (ie, no further TM, up to 2 Motivation And Problem Solving (MAPS) navigation calls) over the next 12 weeks. Patients in TM+ who do not enrol in the EBI (ie, TM+ non-responders) will be randomised to either TM+Continued (ie, monthly text messages) or TM+ & MAPS (ie, monthly text messages, plus up to 2 MAPS calls) over the next 12 weeks. Descriptive statistics will be used to characterise feasibility (eg, proportion of patients eligible, contacted and enrolled in the trial) and acceptability (eg, participant opt-out, participant engagement with dissemination strategies, EBI reach (ie, the proportion of participants who enrol in EBI), adherence, effectiveness).Ethics and dissemination Study protocol was approved by the University of Utah Institutional Review Board (#00139694). Results will be disseminated through study partners and peer-reviewed publications.Trial registration number clinicaltrials.gov; NCT05666323.https://bmjopen.bmj.com/content/13/11/e075157.full |
| spellingShingle | David W Wetter Guilherme Del Fiol Inbal Nahum-Shani Dusti R Jones Bryan Gibson Ellen Maxfield Chelsey R Schlechter Brian Orleans Amy Locke Ryan Cornia Richard Bradshaw Jennifer Wirth Shanna J Jaggers Cho Y Lam Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial BMJ Open |
| title | Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial |
| title_full | Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial |
| title_fullStr | Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial |
| title_full_unstemmed | Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial |
| title_short | Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial |
| title_sort | increasing the reach of evidence based interventions for weight management and diabetes prevention among medicaid patients study protocol for a pilot sequential multiple assignment randomised trial |
| url | https://bmjopen.bmj.com/content/13/11/e075157.full |
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