Abstract
Objective: Improving diet, activity level, and medication adherence and controlling tobacco and other substance use have all been shown to produce measurable, cost-effective improvements in health outcomes. However, many individuals do not respond to available treatments, and efficacious interventions are often not brought to scale. Developing and implementing more potent behavioral treatments in diverse populations to ultimately improve public health involves a focus on behavioral intervention research across the translational spectrum. There has been little attention paid to designs, methods, and analytic techniques for early phase trials. Method: The National Institutes of Health sponsored a cross-institute, 2-day Workshop on Innovative Study Designs and Methods for Developing, Testing and Implementing Behavioral Interventions to Improve Health to review, evaluate, and disseminate a selection of innovative designs and analytic strategies for use in behavioral intervention studies. Results: The workshop was organized to reflect methods appropriate for use across the translational spectrum. Because of the historical attention paid to the randomized clinical trial, the workshop placed particular emphasis on the designing and preliminary testing of behavioral interventions, the optimization of interventions, and the later effectiveness and implementation of trials. Conclusions: This article provides a summary of the methods discussed at the workshop, with recommendations for their use to improve the impact, reach, and costeffectiveness of behavioral intervention research across the translational spectrum.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1081-1091 |
| Number of pages | 11 |
| Journal | Health Psychology |
| Volume | 37 |
| Issue number | 12 |
| DOIs | |
| State | Published - Dec 2018 |
Funding
Given the complications inherent in carrying out trials in real-world settings, behavioral researchers are increasingly partnering with entities that can facilitate both the trial’s implementation and, if successful, the eventual integration of intervention components into health care settings. Coughlin (2014) provided an example of partnering with industry in conducting and implementing the results of a trial of obesity-related interventions in primary care conducted as part of the National Heart, Lung, and Blood Institute’s (NHLBI) Practice-Based Opportunities for Weight Reduction (POWER) program. The trial was led by Appel and colleagues at the Johns Hopkins University (JHU) School of Medicine in collaboration with Healthways, a company providing wellness solutions to employers and large insurance companies (Appel et al., 2011). The study compared the effects of a self-directed control condition with two practical behavioral weight loss interventions that could be implemented in routine medical practice (one remotely delivered via phone, web, and e-mail and the other delivered in person individually or within a group along with remote intervention) on weight loss in obese patients with cardiovascular risk factors. JHU designed and implemented the trial, which was funded by the NHLBI, and Healthways developed and managed the website and conducted the remote intervention. The remotely delivered and in-person interventions were similarly effective in achieving and sustaining clinically significant weight loss over 24 months. JHU worked with Healthways following the end of the trial to develop a weight loss program based on the successful POWER trial intervention and has implemented this program in collaboration with Healthways. Coughlin discussed benefits as well as potential problems resulting from partnerships with industry, with lessons learned including the need for mentorship and strong models to provide guidance for such partnerships, conflict of interest safeguards, standards for commercializing, and additional work to integrate obesity treatment into primary care and make such treatments reimbursable– billable services.
Keywords
- Behavior
- Health
- Methods
ASJC Scopus subject areas
- Psychiatry and Mental health
- Applied Psychology