Results Summary
What was the research about?
In the United States, one in three adults has obesity; among Black women, this number is one in two. Losing weight can help reduce the risk for health problems such as diabetes and improve quality of life. But most people who lose weight gain it back.
In this study, the research team compared two programs to help Black women maintain weight loss after they finished a six-month weight loss program:
- Culturally sensitive program. The research team trained doctors to use behaviors that would make women feel comfortable when talking to them about their weight. Doctors also discussed things that may keep patients from making healthy choices and ways to overcome those barriers. To identify these behaviors, the team held two group discussions with Black women who were similar to the women in the study.
- Standard program. The research team trained doctors in how to provide behavior change information and how to ask questions to help women maintain weight loss.
The research team looked at changes in body weight and other health outcomes.
What were the results?
After one year of the weight loss maintenance program, patients in the culturally sensitive program had lower body weight (7.5 pounds on average) and reported fewer barriers to healthy eating and physical activity than patients in the standard program. Patients in the two programs didn’t differ in:
- Blood pressure
- Blood sugar levels
- Fat levels in blood
- Other aspects of healthy eating, such as choosing healthy foods and limiting soda
- Quality of life
Who was in the study?
This study included 356 Black women with obesity who were 21 years of age and older. The average age was 55. All previously received care at one of 21 clinics in the Jacksonville area of Florida and Georgia.
What did the research team do?
The research team assigned clinics by chance to one of the two programs. Patients received the program assigned to their clinic. Patients in both programs met with doctors every three months for one year.
At the start of the maintenance program and one year later, patients completed surveys about healthy eating, physical activity, and quality of life. The research team also checked patients’ weight and blood pressure and did blood tests.
Black women with obesity, doctors, dieticians, community members, and clinic administrators provided input throughout the study.
What were the limits of the study?
Only about half of the women completed the six-month weight loss program. Results may have differed if more patients could have entered the maintenance program. COVID-19 may have affected patients’ ability to take part in the programs due to changes in their personal lives.
Future research could look at ways to improve how clinics deliver culturally sensitive weight loss and weight loss maintenance programs.
How can people use the results?
Clinics can use the results when considering ways to help Black women maintain weight loss.
Professional Abstract
Objective
To test a tailored, culturally sensitive program delivered by physicians to help Black women with obesity maintain weight loss and improve other health behaviors and outcomes
Study Design
| Design Element | Description |
|---|---|
| Design | Cluster randomized controlled trial |
| Population | 356 Black women ages 21 and older with BMI ≥30 kg/m2 |
| Interventions/ Comparators |
Following a 6-month weight loss program:
|
| Outcomes |
Primary: change in body weight Secondary: change in blood pressure, triglycerides, HbA1c, blood glucose, healthy eating engagement, physical activity engagement, barriers to healthy eating, barriers to physical activity, physical health-related quality of life, and psychological health-related quality of life |
| Timeframe | 1-year follow-up for study outcomes following a 6-month weight loss program |
This cluster randomized controlled trial compared the effectiveness of a culturally sensitive program versus a standard behavioral program on maintaining weight loss and improving other health outcomes among Black women with obesity. The prevalence of obesity among Black women in the United States is 57%, which is higher than the prevalence of obesity among men and other racial groups.
All women in the study had completed a six-month weight loss program. Researchers then randomized 21 primary care clinics to provide one of the two weight loss maintenance programs: culturally sensitive or standard behavioral. Woman participated in the program assigned to their clinic. In both programs, patients met with their physicians every three months for one year.
In the culturally sensitive program, researchers trained physicians to display specific behaviors and attitudes when talking with patients about their weight to promote weight loss maintenance. To develop this program, researchers conducted two focus groups with 14 Black women who wanted to lose weight and identified physician behaviors that made women feel comfortable or uncomfortable when talking about weight.
In the standard behavioral program, researchers trained physicians to use behavioral change principles and motivational interviewing to promote weight loss maintenance.
The study included 356 Black women with a body mass index (BMI) at or above 30 kg/m2. The average age was 55. In the previous two years, all women had had at least two clinic visits in northeast Florida and southeast Georgia.
At the start of the weight loss maintenance program and one year later, women completed surveys about healthy eating, physical activity, and quality of life and in-person assessments for other study outcomes.
Black women with obesity, physicians, dietitians, community members, and hospital administrators provided input throughout the study.
Results
After one year of weight loss maintenance, compared with women in the standard behavioral program, women in the culturally sensitive program:
- Had a lower body weight on average (mean between-group difference was 7.5 pounds; p<0.05).
- Perceived fewer barriers to healthy eating (95% confidence interval [CI]: 7.49, 8.26 versus 95% CI: 7.99, 8.77) and physical activity (95% CI: 6.58, 7.53 versus 95% CI: 7.28, 8.24).
- Did not differ significantly on other secondary outcomes.
Limitations
About 48% of women completed the initial six-month weight loss program. Results may have differed if more women could have entered the weight loss maintenance programs. The COVID-19 pandemic may have affected participation and study results due to changes in patients’ personal lives.
Conclusions and Relevance
In this study, patients in the culturally sensitive program had lower body weight and reported lower barriers to healthy eating and physical activity than patients in the standard behavioral program.
Future Research Needs
Future research could examine ways to enhance delivery of culturally sensitive weight loss and weight loss maintenance interventions in primary care clinics.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Stories and Videos
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 noted that one stated goal of the study was to evaluate the effectiveness of community health workers (CHWs) leading the intervention, but the effectiveness could not be measured because there was no comparison group. The reviewers stated that the lack of a control group made it difficult to discern whether the weight loss was due to the intervention or just to change over time. The researchers removed language attributing the weight loss to the intervention based on the reviewers’ feedback, but pointed out that it was unlikely that the weight loss was actually due to change over time or regression to the mean, since Black women, the target group for this study, tend to gain more weight over time rather than lose weight.
- The reviewers were also concerned about the analyses for the second study aim comparing two weight loss interventions where a significant percentage of the study sample had no follow-up. This resulted in an analysis that could not follow the intent-to-treat analysis preferred in clinical comparative research. The researchers revised their report to acknowledge that there was no way to determine whether the women who stayed in the study were different in some way from the women who did not participate, creating the potential for bias in the result.
- The reviewers questioned the researchers’ conclusions related to integration of CHWs into health care teams in order to deliver the culturally sensitive weight loss intervention. The reviewers felt that the study sample was too small and that the outcome measure was not designed to measure integration as the research team hoped. The researchers revised this section and presented their findings as qualitative and exploratory, describing individual CHW experiences rather than using a quantitative measure of integration.