Increasing Treatment for Obesity Among Underserved Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Proportion of participants who were eligible, contacted, and enrolled in the trial.
研究概览
简要总结
The objective of this project is to evaluate strategies to increase patient engagement in evidence-based interventions (EBIs) for obesity. The scientific premise of the proposed project is based on: 1) substantial evidence that EBIs for obesity are effective but grossly underutilized, 2) promising results indicating that technology-based approaches such as text messaging may increase the reach of EBIs among underserved populations, 3) data demonstrating that repeated offers of treatment can substantially increase enrollment even among patients who are initially unmotivated, and 4) prior research highlighting the effectiveness of Motivation And Problem Solving (MAPS), a proactive coaching approach used to address barriers to improve patient enrollment in EBIs.
Thus, the proposed project will develop, implement, and evaluate two strategies for increasing the assessment and enrollment of University of Utah Medicaid patients in online EBIs for obesity: 1) Repeated offers of EBIs for obesity using text messaging and state of the science health communication strategies, 2) MAPS navigation/counseling among patients who do not enroll in EBIs in response to text messaging. The proposed project will provide critical data regarding the implementation of pragmatic and scalable interventions that are designed to increase the reach of existing EBIs for obesity among underserved populations. Most importantly, the project results lay the foundation for the widespread dissemination of strategies to increase use of EBIs for obesity across Utah, the Mountain West region, and the nation.
Project deliverables include 1) a text messaging intervention for facilitating connection to EBIs for obesity; 2) MAPS intervention for facilitating connection to EBIs for obesity; 3) implementation, adaptation, and optimization of these interventions for University of Utah Medicaid patients, 4) preliminary evidence for the efficacy of these two interventions in improving the reach of EBIs for obesity, and 5) creation of a plan for further dissemination.
详细描述
This study will use a Sequential Multiple Assignment Randomized Trial (SMART) Design, which will allow participants to address questions like those of traditional factorial design and assess dynamic treatment regimens to inform the development of adaptive interventions. An adaptive intervention contains a sequence of individually tailored decision rules that specify the intensity or type of intervention at critical points in the delivery of care. Modifying intensity or type of intervention over time can improve outcomes if an individual is not responding, or may reduce costs and patient burden if more resource intensive treatment is not necessary. As such, the proposed SMART design informs the development of adaptive and stepped care interventions, and the reduction in patient burden is particularly important to ensure that the interventions are as patient centered as possible.
The first randomization is a patient-level randomization to text messaging (single) versus text messaging (multiple) among eligible patients. The second randomization is a patient-level randomization to Motivation And Problem Solving (MAPS) coaching vs. no MAPS among the remaining patients in the text message conditions who do not enroll in the EBI. The primary outcome for this study is enrollment in an online EBI for obesity. IncentaHEALTH provides EBIs for obesity to the University of Utah Health system, either the Diabetes Prevention Program or Lifestyle Change Program. Their online Diabetes Prevention Program (DPP) is fully recognized by CDC.
Study Design:
To identify the cohort for the intervention, patient data will be extracted from the University of Utah EHR. Data fields will include variables such as age, gender, body mass index, pregnancy status, medical codes (e.g., ICD-10 for Type 1 and Type 2 diabetes), patient demographics (e.g., zip code, insurance status, preferred language, race/ethnicity); as well as contact information for text messaging and patient navigation. Patients who fit within the inclusion/exclusion criteria will be randomly selected and assigned to the conditions described below.
This study will take place in two Stages spanning a 6-12 month period. In Stage 1 (0 - 12 weeks), participants will be randomized to one of two conditions: Text Messaging 1 (Single text; hereafter referred to as TM1), or Text Messaging Plus (Multiple texts; hereafter referred to as TM+). The study team will use a 1:1 randomization ratio (TM1: TM+).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be adults aged 18+
- •have a BMI of 30 or higher
- •have had a primary care appointment within University of Utah Health within the past year
- •speak English or Spanish as their primary language
- •have a current Utah address
- •are insured through Medicaid (University of Utah Health Plans).
排除标准
- •patients may not have a diagnosis of Type 1 or Type 2 Diabetes
- •being currently pregnant
结局指标
主要结局
Proportion of participants who were eligible, contacted, and enrolled in the trial.
时间窗: at 12 weeks
Proportion of participants who were eligible, contacted, and enrolled in the trial.
次要结局
- Participant engagement with dissemination strategies(at 24 weeks)
- Evidence-Based Intervention Engagement(at 12 weeks from enrollment)
- Evidence-Based Intervention REACH Phase 1(at 12 weeks)
- Evidence-Based Intervention REACH Phase 2(at 24 weeks)