Results Summary
What was the research about?
Primary care clinics can help patients with obesity manage their weight. To do so, clinicians, such as doctors and nurses, usually have in-person office visits with patients that last 15 minutes. But in rural areas, fewer clinic staff are available to offer these visits.
In this study, the research team compared three ways clinics in rural areas could offer a weight management program:
- In-person group visits at the clinic with 8 to 18 people per group
- Remote group visits by phone with 10 to 17 people per group
- In-person one-on-one visits at the clinic
For all three ways, the program included visits with trained staff to set goals for diet and physical activity. The first six months focused on weight loss. The next 18 months focused on maintaining weight loss. Topics included physical activity, healthy eating, and social support.
What were the results?
After two years, in all three ways, patients lost weight and had improved physical activity, diet, weight-related quality of life, and sleep quality.
Compared with in-person visits that were one-on-one, patients who had in-person group visits
- Lost 1.9 more kilograms (4.2 pounds) and a greater percentage of weight
- Had greater decreases in triglycerides, or fat levels, in the blood
- Had greater increases in physical activity
Patients who had in-person visits that were one-on-one and in-person group visits didn’t differ in
- Whether patients lost at least 5 or 10 percent of their weight
- Blood pressure or cholesterol
- Quality of life, sleep, or stress
- Symptoms of anxiety and depression
Patients who had remote group visits didn’t differ in weight loss or other health outcomes from patients who had in-person group or one-on-one visits.
Who was in the study?
The study included 1,407 patients with obesity. Of these, 96 percent were White, and 4 percent were another race. The average age was 55, and 77 percent were women. Patients received care at one of 36 clinics in the rural Midwest.
What did the research team do?
The research team assigned clinics by chance to offer the program in one of the three ways. Patients used the method assigned to their clinic. For in-person one-on-one visits, clinics offered 32 visits lasting 15 minutes each. Visits happened weekly for one month, every other week for five months, and monthly for the rest of the study. For in-person and remote group visits, clinics offered 36 visits lasting 60 minutes each. Visits or phone calls took place weekly for the first three months, every other week for three months, and monthly for the rest of the study.
Patients completed surveys or in-person visits every 6 to 12 months for two years.
Patients with obesity and clinicians gave input on the study.
What were the limits of the study?
Most patients were White women living in the Midwest. Results may differ for patients from other backgrounds or locations.
Future studies could include more men or patients from other backgrounds or locations.
How can people use the results?
Clinics and patients can use these results when considering approaches to managing weight loss.
| How this project fits under PCORI’s Research Priorities PCORI identified obesity as an important research topic. Patients, primary care clinicians, and others wanted to learn: Which treatment options achieve the best weight-loss outcomes for adults, especially those who are from minority racial/ethnic groups, have low socioeconomic status, or live in rural areas? To help answer this question, PCORI launched an initiative in 2014 on Obesity Treatment Options Set in Primary Care for Underserved Populations: Pragmatic Clinical Trials to Evaluate Real-World Comparative Effectiveness. The initiative funded this research project and one other. |
Professional Abstract
Objective
To compare the effectiveness of three delivery methods for an intensive lifestyle intervention on improving patients’ weight management
Study Design
| Design Element | Description |
|---|---|
| Design | Cluster randomized controlled trial |
| Population | 1,407 adults ages 20–75 who were living in a rural area and who had a BMI between 30 and 45 |
| Interventions/ Comparators |
|
| Outcomes |
Primary: change in body weight, percent weight loss, weight loss ≥5%, weight loss ≥10% Secondary: cardiometabolic risk factors including total cholesterol, triglycerides, LDL, and HDL; dietary measures including fruit and vegetable intake, sugar sweetened beverages, and frequency of eating meals outside the home; sleep quality; stress, anxiety, and depression; quality of life and weight-related quality of life |
| Timeframe | 2-year follow-up for primary outcomes |
This pragmatic cluster randomized controlled trial compared the effectiveness of three delivery methods for an intensive lifestyle intervention on improving patient outcomes. The program included meetings with trained staff to set short-term goals for diet and physical activity. Goals focused on weight loss for 6 months and then weight loss maintenance for 18 months. Meeting topics included physical activity, portion control, and social support.
Researchers randomized 36 rural primary care clinics to offer the program using one of the three delivery methods. Patients used the method assigned to their clinic:
- Disease management (DM) delivery. Patients participated in 36 remote group counseling phone calls with study staff, lasting one hour each. Groups included between 10 and 17 people.
- Patient-centered medical home (PCMH) delivery. Patients participated in 36 in-person group counseling visits with practice-employed clinicians, lasting 60 minutes each. Groups included between 8 and 18 people.
- Traditional fee-for-service (FFS) delivery. Patients received 32 in-person, individual counseling sessions with practice-employed clinicians, lasting 15 minutes each.
For DM and PCMH delivery, visits took place weekly for the first three months, every other week for months four to six, and monthly thereafter. FFS delivery followed the frequency reimbursed by Medicare: weekly for one month, every two weeks for months two to six, and monthly thereafter.
The study included 1,407 patients with a body mass index (BMI) between 30 and 45 who lived in the rural midwestern region of the United States. Of these, 96% were White, and 4% were another race. The average age was 55, and 77% were female.
Patients completed surveys or in-person assessments every 6 to 12 months for two years.
Patients with obesity and clinicians provided input on the study.
Results
After two years, patients in all groups showed significant improvements in weight loss, physical activity, dietary measures, weight-related quality of life, and sleep quality.
Compared with patients in the FFS group, patients in the PCMH group
- Lost 1.9 more kilograms (97.5% confidence interval [CI]: -3.51, -0.23)
- Lost a greater percentage of weight (95% CI: -3.22, -0.41)
- Had greater decreases in triglycerides (95% CI: -29.03, -8.39) and greater increases in physical activity (95% CI: 0.07, 4.47)
- Did not differ significantly on other study outcomes
Patients in the DM group did not differ significantly on any outcomes compared with patients in the FFS and PCMH groups.
Limitations
Most patients were White women living in the rural Midwest. Results may differ for patients from other backgrounds or geographic locations.
Conclusions and Relevance
A weight management program delivered using in-person group visits resulted in more weight loss than the FFS delivery model after two years. Delivery using remote group visits did not improve health outcomes more than in-person visits.
Future Research Needs
Future research could include more men or patients from other racial backgrounds or geographic areas.
| How this project fits under PCORI’s Research Priorities PCORI identified obesity as an important research topic. Patients, primary care clinicians, and others wanted to learn: Which treatment options achieve the best weight-loss outcomes for adults, especially those who are from minority racial/ethnic groups, have low socioeconomic status, or live in rural areas? To help answer this question, PCORI launched an initiative in 2014 on Obesity Treatment Options Set in Primary Care for Underserved Populations: Pragmatic Clinical Trials to Evaluate Real-World Comparative Effectiveness. The initiative funded this research project and one other. |
Final Research Report
View this project's final research report.
Implementation
Related PCORI Dissemination and Implementation Project
Journal Citations
Article Highlight: People living in rural areas are more likely to have obesity than those living in cities, and they are also less likely to have access to weight loss programs. This study compared three ways to treat obesity in rural populations: regular in-person clinic sessions, in-person group sessions, and phone-based group sessions. In a JAMA paper published in January 2021, the study found that people in the in-person group sessions averaged greater weight loss after 24 months than the other two groups.
Results of This Project
Related Journal Citations
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:
- The reviewers generally found the report to be well written and had few comments.
- The reviewers commented on the researchers’ description of how they handle replacing a site that dropped out of the study, noting that replacing a site in a cluster-randomized trial is difficult and likely to result in some potential bias when comparing the two interventions. The researchers responded by adding the loss and replacement of a site as a study limitation because of the possibility of bias and also described sensitivity analyses they performed which did not indicate the presence of bias in the sample due to the replaced site.
- The reviewers asked the researchers how they accounted for delivering their group-based disease management intervention to patients in multiple clusters, so that patients in different clusters had related experiences. The researchers explained that they modeled this part of the intervention after the disease management industry where call centers are centralized and not specific to a practice. They acknowledged that having correlations among patients from different clusters created a statistical challenge but reported that they have used this as an opportunity to develop new statistical methods for small clusters of patients being mixed among randomized clusters of practices.
- The reviewers asked the researchers to address the problem of rebound weight gain over time that would reduce between-group differences seen early in weight-loss interventions. The researchers added a paragraph to the report discussing the weight regain between 6 and 24months postintervention and noted the importance of studying longer-term interventions to support the maintenance of a healthy diet and physical changes.