Sustaining the reach of a scalable weight loss intervention through financial incentives- a pragmatic, feasibility, online randomized trial protocol

Michaud, Tzeyu L.; Estabrooks, Paul A.; You, Wen; McGuire, T.; Almeida, Fabio A.; Karls, Kelly; Love, Kenya; King, Keyonna M.; Hill, Jennie L.; Reed, Jill R.; Porter, Gwenndolyn; Su, Dejun

doi:10.1016/j.cct.2020.106142

Cited by 4 publications

(1 citation statement)

References 42 publications

(54 reference statements)

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“…We did include a washout period to screen out individuals who did not truly have uncontrolled HTN and identify those who were not fully vested in trial participation, but neither of these is a culture specific approach. Michaud and colleagues [35] have suggested that a high incentive program may be effective in decreasing the attrition rate for digital health interventions for increasing physical activity for Black women. Although we incorporated a distributed incentive system, which rewarded participants for each visit completion, this was not sufficient to prevent the high dropout rates that echoed those in similar digital intervention studies.…”

Section: Discussionmentioning

confidence: 99%

The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial (Preprint)

Buis,

Kim,

Sen

et al. 2024

Preprint

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BACKGROUND Hypertension (HTN) is one of the most important cardiovascular disease risk factors and affects over 100 million American adults. HTN-related health inequities are abundant in Black communities as Blacks are more likely to utilize the emergency department (ED) for chronic disease-related ambulatory care, which is strongly linked to lower BP control, diminished awareness of HTN, and adverse cardiovascular events. To reduce HTN-related health disparities, we developed MI-BP, a culturally tailed multi-behavior mHealth intervention that targeted behaviors of blood pressure self-monitoring, physical activity, sodium intake, and medication adherence in Blacks with uncontrolled HTN who were recruited from ED and community-based settings. OBJECTIVE We sought to determine the effect of MI-BP on BP, as well as secondary outcomes of physical activity, sodium intake, and medication adherence, compared to enhanced usual care control at one-year follow-up. METHODS We conducted a one-year, two-group RCT of the MI-BP intervention compared to an enhanced usual care where participants received a blood pressure cuff. Participants were recruited from EDs and other community-based settings in Detroit, MI, where they were screened for initial eligibility and enrolled. Baseline data collection and randomization occurred about 2- and 4-weeks after enrollment to ensure participants had uncontrolled hypertension and were willing to participate. Data collection visits occurred at 13-, 26-, 39-, and 52-weeks. Outcomes of interest included BP (primary outcome), as well as physical activity, sodium intake, and medication adherence (secondary outcomes). RESULTS We consented and enrolled 869 participants in this study, yet ultimately randomized 162 participants. At one-year, compared to baseline, both groups demonstrated significant decreases in SBP (MI-BP = 22.5 mmHg decrease in average SBP, p < .0001; control group = 24.1 mmHg decrease, p < .0001), adjusted for age and sex, with no significant differences between groups (time-by-arm interaction p = .99). Similar patterns, where improvements were noted for both groups, yet no differences were found between groups, were demonstrated for diastolic BP, physical activity, sodium intake, and medication adherence. Large dropout rates were observed for both groups (about 60%). CONCLUSIONS Overall, participants randomized to both the enhanced usual care control and MI-BP conditions experienced significant improvements in blood pressure and other outcomes, however, differences between groups were not detected, speaking to the general benefit of proactive outreach and engagement focused on cardiometabolic risk reduction in urban dwelling, low-SES Black populations. High rates of dropout were found and are likely to be expected when working in similar populations. Future work is needed to better understand engagement with mHealth interventions, particularly in this population. CLINICALTRIAL ClinicalTrials.gov NCT02360293; http://clinicaltrials.gov/ct2/show/NCT02360293. International registered report identifier (irrid): RR1-10.2196/12601. INTERNATIONAL REGISTERED REPORT RR2-10.2196/12601

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Section: Discussionmentioning

confidence: 99%

The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial (Preprint)

Buis,

Kim,

Sen

et al. 2024

Preprint

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Randomized clinical trials of weight loss: Pragmatic and digital strategies and innovations

Jain

Bajaj

Stanford

2022

Contemporary Clinical Trials

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During the COVID-19 pandemic, digital strategies and decentralized approaches allowed for the continuation of weight loss clinical trials despite in-person engagement coming to a halt. In particular, trials leveraged remote mediums to measure data in real-time across a broad array of metrics while testing novel strategies to streamline patient care. Such approaches may address longstanding challenges with traditional trials, including attrition and underrepresentation of racial and ethnic minorities. Ultimately, emerging data from trials utilizing both digital and in-person strategies may indicate the promise of a hybrid approach in incorporating a robust virtual component for continuous patient monitoring and an in-person component for patient adherence and data standardization. In this commentary, we provide an overview of the most innovative digital approaches in clinical trials of weight loss during the COVID-19 era, as well as identify opportunities and challenges for these modes of research going forward.

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Effectiveness of incentives to improve the reach of health promotion programs- a systematic review and meta-analysis

Michaud

Estabrooks

You

et al. 2022

Preventive Medicine

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Sustaining the reach of a scalable weight loss intervention through financial incentives- a pragmatic, feasibility, online randomized trial protocol

Cited by 4 publications

References 42 publications

The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial (Preprint)

The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial (Preprint)

Randomized clinical trials of weight loss: Pragmatic and digital strategies and innovations

Effectiveness of incentives to improve the reach of health promotion programs- a systematic review and meta-analysis

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