Results Summary
What was the research about?
Diabetes is a long-term health problem that causes blood sugar levels to rise. Keeping blood sugar levels within a healthy range can help prevent damage to the body. Self-care activities like eating healthy, exercising, and taking medicine as recommended can help people manage their diabetes. But making changes can be hard, especially for people with other chronic health problems, like high blood pressure, or for those who live in low-income areas.
In this study, the research team compared three approaches for improving self-care activities among African-American adults with diabetes and other chronic health problems who live in low-income areas:
- Education guide alone. Patients received a diabetes education guide and went over it with a member of the research team. The guide included information about diabetes, healthy behaviors, and community and online resources.
- Text messaging plus guide. Patients received the guide and also received texts with health information and reminders for one year. Patients helped decide how often they would get texts and what topics would be covered.
- Health coaching plus guide. Patients received the guide and also had in-person or phone meetings with a trained health coach at least once a month for one year. Coaches helped patients set health goals, create healthy habits, and find social support.
What were the results?
After one year, in all three approaches, patients reported that they increased the number of days they followed a healthful eating plan and exercised. They didn’t improve how often they took their medicine.
Compared with patients who received the education guide alone:
- Patients who also received text messages reported more days of following a healthful eating plan.
- Patients who also received coaching didn’t differ in the number of days they followed a healthful eating plan.
Across the three approaches, patients didn’t differ in the number of days they exercised or took diabetes medicines as recommended.
Who was in the study?
The study included 666 African-American adults with diabetes and one or more chronic health problems. All received care at one of 18 clinics in the Mid-South region. The average age of patients was 54, and 67 percent were women. Also, 90 percent of patients lived in low-income areas.
What did the research team do?
The research team assigned patients by chance to one of the three approaches.
At the start of the study and again one year later, patients completed surveys about their self-care activities.
Patients, doctors, and community groups provided input during the study.
What were the limits of the study?
This study took place in the Mid-South region; results may differ in other regions. Most patients took diabetes medicine as recommended when the study began. As a result, it was hard to see improvements.
Future research could look at delivering the three approaches together to improve self-care or allowing patients to choose the approach they like best.
How can people use the results?
Doctors and clinics can use these results when considering approaches to best support African-American adults with diabetes and other chronic health problems living in low-income areas.
Professional Abstract
Objective
To compare the effectiveness of motivational text messaging plus educational materials, health coaching plus educational materials, and educational materials alone on improving self-care activities among African-American adults with diabetes and multiple chronic conditions
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 666 African-American adults with uncontrolled diabetes and 1 or more additional chronic health conditions who live in low-income or medically underserved neighborhoods |
| Interventions/ Comparators |
|
| Outcomes |
Patient-reported diabetes self-care activities: number of days following a healthful eating plan, exercising, and taking diabetes medication as recommended |
| Timeframe | 1-year follow-up for study outcomes |
This pragmatic randomized controlled trial compared the effectiveness of three approaches to improve diabetes self-care.
In addition to usual care from their doctors, all patients received educational materials on diabetes self-care and reviewed them in person with a researcher. The materials included information about healthy behaviors and community and online resources.
Researchers randomly assigned patients to one of three groups:
- Text messaging plus educational materials. Patients received personalized text messages for one year to support healthy behavior. Researchers tailored the frequency, timing, and focus of messages to participants’ needs and interests.
- Health coaching plus educational materials. Patients received one-on-one meetings in person or by phone with a trained health coach for one year. Coaches helped patients set health goals, develop healthy habits, and connect with social support. Sessions were held twice a month for two or three months and then monthly thereafter.
- Educational materials alone. Patients received educational materials without additional support.
The study included 666 African-American adults with diabetes and one or more chronic health conditions, including hypertension, high cholesterol, or arthritis. Patients received care at one of 18 primary and specialty clinics in the Mid-South region. The average age of patients was 54, 67% were female, and 90% lived in low-income or medically underserved neighborhoods.
Participants completed surveys about diabetes self-care activities at baseline and then again 3, 6, and 12 months later.
Patients, doctors, and community groups provided input throughout the study.
Results
After one year, in all groups, patients reported an increase in the average number of days they followed a healthful eating plan (all p<0.001) and exercised (all p<0.001) but did not report an increase in the number of days they took their diabetes medicines as recommended.
Compared with patients who received educational materials alone:
- Patients who also received text messages reported greater increases in the number of days they followed a healthful eating plan (p= 0.004).
- Patients who also received health coaching did not differ significantly in the number of days they followed a healthful eating plan.
Patients in the three groups did not differ significantly in the number of days they exercised or took diabetes medications as recommended.
Limitations
This study took place in the Mid-South region; results may differ in other regions. Because patients reported high adherence to diabetes medication at baseline, detecting improvements was difficult.
Conclusions and Relevance
All three approaches improved patient-reported diet and exercise among African-American adults with diabetes and other chronic conditions. Receiving tailored text messages was more effective at improving diet than receiving educational materials alone.
Future Research Needs
Future studies could examine whether the effectiveness of these approaches increases when combining the three approaches to improve diabetes self-care or when patients can select their preferred approach.
Final Research Report
This project's final research report is expected to be available by September 2023.
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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 questioned the researchers’ conclusions of treatment success given that the sample of study participants was limited to those who were most adherent to the study requirements and therefore likely to be most amenable to change their behaviors. The researchers acknowledged selection bias of study participants could have contributed to the overall positive results.
- The reviewers also disagreed with the researchers’ contention that there was a causal relationship between all three treatment conditions and participants’ improvement given the lack of a true control group, such as a group of participants receiving no care or usual care. The researchers initially acknowledged the lack of a control group in their revised report but did not remove their causal conclusions. The researchers explained that there have been several studies demonstrating the ineffectiveness of usual care in changing health behaviors, which the reviewers noted was a historical comparison and not as strong as a direct comparison in a randomized trial. The researchers eventually removed their conclusions about the effectiveness of all three treatment interventions given the lack of a control group.
- The reviewers noted that the report referenced the interventions as low cost but did not provide data to support that description. The researchers added a section on intervention costs to their methods and results sections and described the limitations to their cost-assessment methods in the discussion.