Results Summary

What was the research about?

Losing weight may prevent or delay the start of type 2 diabetes and prevent health problems due to diabetes. Obesity counseling called intensive behavioral therapy, or IBT, is effective for weight loss. In IBT, doctors screen and counsel patients about weight management. After 2012, health insurers started to reimburse primary care doctors for IBT.

In this study, the research team used health records and insurance claims from 2009 to 2020 for patients with diabetes or at risk for diabetes at six health systems to see how:

  • The payment change for doctors affected use of IBT.
  • IBT affected patients’ weight loss and other health outcomes.

What were the results?

Before the payment change, health records rarely captured IBT use. After the payment change, less than 1 percent of eligible patients received IBT. Among patients receiving IBT, the usual number of IBT visits was one.

Among patients with diabetes, weight loss and blood pressure control didn’t differ between patients who did and didn’t receive IBT. Patients who received IBT had a larger decrease in blood sugar levels. They also had a smaller increase in uncontrolled diabetes.

Among patients at risk for diabetes, patients gained weight whether they received IBT or not. Patients who received IBT gained more weight than patients who didn't receive it. Changes in blood sugar levels and blood pressure didn’t differ between patients who did and didn’t receive IBT.

What did the research team do?

The research team looked at how many patients received IBT before and after the payment change. The team looked at data for 567,908 patients with diabetes and 2,054,256 patients at risk for diabetes. Across these patients, 80 percent were White, 11 percent were Black or African American, 8 percent were another race or race was missing; 5 percent were Hispanic. The average age was 47, and 57 percent were women.

To assess the effects of IBT, the research team compared patients who received IBT with patients who didn’t receive it but were eligible based on their weight. The team looked at changes in health outcomes from one year before patients had, or were eligible for, IBT versus one year later for:

  • 4,944 patients with diabetes. Of these, 75 percent were White, 20 percent were Black or African American, and 1 percent were another race; 3 percent were Hispanic. The average age was 58, and 62 percent were women.
  • 10,781 patients at risk for diabetes. Of these, 83 percent were White, 12 percent were Black or African American, and 1 percent were another race; 3 percent were Hispanic. The average age was 44, and 80 percent were women.

Patients with diabetes, doctors, and staff from health systems, diabetes organizations, and community organizations gave input on the study.

What were the limits of the study?

Data didn’t include things like doctor practices, which could have affected the results.

Future research could look at reasons for the low use of IBT.

How can people use the results?

Patients and their doctors can use the results when considering IBT for diabetes.

How this project fits under PCORI’s Research Priorities
The research reported in this results summary was conducted using PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® is intended to improve the nation’s capacity to conduct health research, particularly comparative effectiveness research (CER), efficiently by creating a large, highly representative network for conducting clinical outcomes research. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute® (PCORI®).

Final Research Report

This project's final research report is expected to be available by February 2023. 

Peer-Review Summary

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:

  • This final report was a combined description of the main research study and the COVID-19 enhancement project. Peer reviewers were asked to assess both parts of the work.
  • The statistical reviewer advised the researchers to provide more information on how they calculated sample size for the study, and in particular to clarify what the researchers meant in stating that their sample size could detect “very small effect sizes.” The researchers expanded their sample size justification by describing how they estimated the sample sizes in the planning stage of the study. In addition the researchers specified that they calculated that their sample size would have 90% power to detect an effect as small as 0.026 units of change in the main outcomes.
  • Reviewers noted that the COVID-19 enhancement project (aim 3 in the report) was unclear on whether the aim was focused on telemedicine access or telemedicine use. The researchers edited the report to clarify that the study focused telemedicine use and identified additional limitations to making conclusions about the relationship between telemedicine use and the severity of COVID-19 infection. The reviewers cautioned the researchers to also avoid any language in the report that might lead readers to think that telemedicine use had a causal link to COVID-19 severity as opposed to having an association based on the study results.
  • The reviewers suggested that the researchers provide more justification for comparing a single intensive behavioral therapy visit to no visit, asking whether going to one visit would be likely to have a clinically significant effect on weight loss. The researchers responded that since there is no evidence of how many sessions are associated with clinically significant weight loss, they analyzed the study participants based on how many treatment visits participants made. Since more than half of participants had only one session and there was no evidence that more sessions were associated with greater weight loss, the researchers decided to use one visit as the threshold.

Conflict of Interest Disclosures

Project Information

Jennifer Kraschnewski, MD, MPH
Penn State Health Milton S. Hershey Medical Center
$2,840,130
A Patient-Centered PaTH to Addressing Diabetes: Impact of State Health Policies on Diabetes Outcomes and Disparities

Key Dates

January 2016
June 2022
2016
2022

Study Registration Information

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Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
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Last updated: November 30, 2022