Results Summary and Professional Abstract
|This project's final research report is expected to be available by November 2021.|
|Results Highlights: Reporting in the New England Journal of Medicine, this study found that an intensive healthy lifestyle intervention—which included health coaches embedded in primary care practices working with patients to develop healthy habits—resulted in patients losing significantly more weight than those who received usual care from their primary care clinics, and they kept more weight off at two years later. The results show that successful weight loss can be achieved in primary care settings in a highly underserved population who have significant barriers to obtaining health care services.|
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers requested more information about how the health coaches who provided intensive lifestyle interventions fit into the clinical practices where they worked, including information about their access to medical records and their reimbursement for services. The researchers explained that the coaches were all salaried employees paid by the PCORI award and did not bill for their services. The coaches did not have access to electronic medical records and did not communicate with providers about patients because of privacy concerns. Similarly, primary care providers knew that their patients were participating in this study but did not have access to the computer tracking system used in the research.
- The reviewers asked how often participants used the computerized tool for tracking weight and feedback from coaches. The researchers explained that while the computer tracking system was designed for participants, participant use of the system was not systematically assessed. The researchers estimated that most participants did not access the computer tracking system’s weight graphs on their own but instead viewed printed versions of graphs that their health coaches provided.
- The reviewers requested that the researchers discuss the clinical significance of functional status measures, rather than reporting only statistical significance. The researchers noted that determining the clinical significance on quality of life and functioning measures was dependent on the population. Therefore, they revised the report noting whether or not the differences between treatment groups fell into the range where they would be considered clinically significant, but also cautioned readers that the range for clinical significance was not established in a population similar to this study’s.
- The reviewers asked why weight loss in the intensive lifestyle intervention group appeared to be less among African Americans and how weight loss could be increased in that population. The researchers said this is an important question that the study had not explored. They added that they will address the issue of lower weight loss among African American populations in a future paper.
Conflict of Interest Disclosures
View the COI disclosure form.
Other Clinical Interventions
Other Health Services Interventions
Incentives for Behavior Change
Training and Education Interventions