Benefits of lifestyle intervention only brief in some patients with type 2 diabetes

NEW ORLEANS – Underserved African Americans with type 2 diabetes mellitus who participated in a year-long intensive self-management program did not experience sustained serum glucose control, compared with a control group receiving only two diabetes education classes.

“Relative to non-Hispanic whites, African Americans with type 2 diabetes experience more diabetes-related complications and higher rates of diabetes hospitalization,” lead study author Elizabeth B. Lynch, Ph.D., said at the annual scientific sessions of the American Diabetes Association. “These disparities are even greater for underserved disadvantaged African American populations.”

Dr. Lynch, a psychologist who directs the section of community health in the department of preventive medicine at Rush University Medical Center, Chicago, noted that several self-management interventions for diabetes have demonstrated efficacy at improving glucose control at 6 months. “However, there have not been any diabetes self-management interventions specifically targeting African Americans that have achieved sustained blood glucose control,” she said.

In a trial known as Lifestyle Intervention Through Food and Exercise (LIFE), the researchers examined the effect of a group-based intervention on glucose control at 12 months in a population of low-income African Americans. The intervention components consisted of cognitively tailored nutrition education taught by a registered dietitian, behavioral modification, social support, and peer support. “This education curriculum was based on a series of studies that were done using cognitive anthropological methods with low-income African Americans looking at beliefs and knowledge about the relationship between food and health,” Dr. Lynch said. “We used those studies to design an intervention with the aim of reducing cognitive load among participants when they’re learning new information about nutrition, so essentially making the information easier for people to understand.” Behavioral modification techniques included goal setting, self-monitoring, and problem solving. “We also had social support, and there was a peer supporter who was an individual from the community with type 2 diabetes who was assigned to each of the participants and called them on a regular basis to check in with them on their goals and encourage them,” she said.

The LIFE program consisted of 20 group sessions in the first 6 months and 8 sessions in the second 6 months, while a control group received 2 group-based education classes in the first 6 months only. The researchers conducted assessments at baseline, 6 months, and 12 months.

Individuals were eligible for the trial if they were African American, were a patient of a community clinic affiliated with Cook County Healthcare System, had a clinical diagnosis of type 2 diabetes, and had a hemoglobin A_1c level of 7% or greater. Of 1,403 initially screened for the trial, 603 were found to be eligible. Of these, 211 were randomized and enrolled: 106 to the treatment group and 105 to the control group. There was 94% follow-up at 6 and 12 months.

At baseline, the mean age of study participants was 55 years, 70% were female, 46% had a high school education or less, 60% had an annual income of less than $24,000, 65% were uninsured, and 39% had limited health literacy. Baseline food intake as reported by two 24-hour food recalls consisted of a diet high in saturated fat and low in fiber, with a moderate intake of carbohydrates and underconsumption of fruits, vegetables, and dairy products. The baseline level of daily physical activity as measured by accelerometry revealed sedentary activity that exceeded 7 hours per day, 3,614 steps per day, and only 14 minutes per day of moderate-level activity. Study enrollees had a baseline HbA_1c level of 9% and a diabetes duration of 11 years; 45% used insulin, and 48% had poor medication adherence. Their mean body mass index was 35.6 kg/m², and 91% had hypertension.

More than half of individuals in the intervention group attended each of the 20 group sessions, and 90% attended at least 1. At the same time, 68% of individuals in the control group attended both educational sessions. Dr. Lynch reported that compared with the control group, the intervention group had a significantly greater reduction in HbA_1c at 6 months (–0.76 vs. –0.21, respectively; P = .026) but not at 12 months (–0.63 vs. –0.45; P = .47). In addition, a higher percentage of individuals in the treatment group had a 0.5% or more decline in HbA_1c level at 6 months (63% vs. 42%, P = .005) but not at 12 months (53% vs. 51%, P = .89). The fact that the control group also had a reduction in HbA_1c presented a conundrum for the researchers. “One possible explanation for the decrease in A_1c in the control group is that medication adherence increased in this group, relative to the intervention group,” Dr. Lynch explained in a press release. “Additional research is needed to identify the most effective strategies to achieve sustained A_1c control in African Americans with type 2 diabetes.”

No changes were observed in blood pressure, weight, or physical activity over the course of 12 months in either group.

Although LIFE lacked a third study arm that received usual care, one possible implication of the current findings “may be that diabetes education of any type may be helpful in improving glycemic control, especially in a population that does not normally receive any education,” she said. “Medication adherence may be an easier and more effective strategy to improve glycemic control in this population.”

LIFE was supported by grants from the National Institutes of Health. Dr. Lynch reported having no relevant financial disclosures.

dbrunk@frontlinemedcom.com

NEW ORLEANS – Underserved African Americans with type 2 diabetes mellitus who participated in a year-long intensive self-management program did not experience sustained serum glucose control, compared with a control group receiving only two diabetes education classes.

“Relative to non-Hispanic whites, African Americans with type 2 diabetes experience more diabetes-related complications and higher rates of diabetes hospitalization,” lead study author Elizabeth B. Lynch, Ph.D., said at the annual scientific sessions of the American Diabetes Association. “These disparities are even greater for underserved disadvantaged African American populations.”

Dr. Lynch, a psychologist who directs the section of community health in the department of preventive medicine at Rush University Medical Center, Chicago, noted that several self-management interventions for diabetes have demonstrated efficacy at improving glucose control at 6 months. “However, there have not been any diabetes self-management interventions specifically targeting African Americans that have achieved sustained blood glucose control,” she said.

In a trial known as Lifestyle Intervention Through Food and Exercise (LIFE), the researchers examined the effect of a group-based intervention on glucose control at 12 months in a population of low-income African Americans. The intervention components consisted of cognitively tailored nutrition education taught by a registered dietitian, behavioral modification, social support, and peer support. “This education curriculum was based on a series of studies that were done using cognitive anthropological methods with low-income African Americans looking at beliefs and knowledge about the relationship between food and health,” Dr. Lynch said. “We used those studies to design an intervention with the aim of reducing cognitive load among participants when they’re learning new information about nutrition, so essentially making the information easier for people to understand.” Behavioral modification techniques included goal setting, self-monitoring, and problem solving. “We also had social support, and there was a peer supporter who was an individual from the community with type 2 diabetes who was assigned to each of the participants and called them on a regular basis to check in with them on their goals and encourage them,” she said.

The LIFE program consisted of 20 group sessions in the first 6 months and 8 sessions in the second 6 months, while a control group received 2 group-based education classes in the first 6 months only. The researchers conducted assessments at baseline, 6 months, and 12 months.

Individuals were eligible for the trial if they were African American, were a patient of a community clinic affiliated with Cook County Healthcare System, had a clinical diagnosis of type 2 diabetes, and had a hemoglobin A_1c level of 7% or greater. Of 1,403 initially screened for the trial, 603 were found to be eligible. Of these, 211 were randomized and enrolled: 106 to the treatment group and 105 to the control group. There was 94% follow-up at 6 and 12 months.

At baseline, the mean age of study participants was 55 years, 70% were female, 46% had a high school education or less, 60% had an annual income of less than $24,000, 65% were uninsured, and 39% had limited health literacy. Baseline food intake as reported by two 24-hour food recalls consisted of a diet high in saturated fat and low in fiber, with a moderate intake of carbohydrates and underconsumption of fruits, vegetables, and dairy products. The baseline level of daily physical activity as measured by accelerometry revealed sedentary activity that exceeded 7 hours per day, 3,614 steps per day, and only 14 minutes per day of moderate-level activity. Study enrollees had a baseline HbA_1c level of 9% and a diabetes duration of 11 years; 45% used insulin, and 48% had poor medication adherence. Their mean body mass index was 35.6 kg/m², and 91% had hypertension.

More than half of individuals in the intervention group attended each of the 20 group sessions, and 90% attended at least 1. At the same time, 68% of individuals in the control group attended both educational sessions. Dr. Lynch reported that compared with the control group, the intervention group had a significantly greater reduction in HbA_1c at 6 months (–0.76 vs. –0.21, respectively; P = .026) but not at 12 months (–0.63 vs. –0.45; P = .47). In addition, a higher percentage of individuals in the treatment group had a 0.5% or more decline in HbA_1c level at 6 months (63% vs. 42%, P = .005) but not at 12 months (53% vs. 51%, P = .89). The fact that the control group also had a reduction in HbA_1c presented a conundrum for the researchers. “One possible explanation for the decrease in A_1c in the control group is that medication adherence increased in this group, relative to the intervention group,” Dr. Lynch explained in a press release. “Additional research is needed to identify the most effective strategies to achieve sustained A_1c control in African Americans with type 2 diabetes.”

No changes were observed in blood pressure, weight, or physical activity over the course of 12 months in either group.

Although LIFE lacked a third study arm that received usual care, one possible implication of the current findings “may be that diabetes education of any type may be helpful in improving glycemic control, especially in a population that does not normally receive any education,” she said. “Medication adherence may be an easier and more effective strategy to improve glycemic control in this population.”

LIFE was supported by grants from the National Institutes of Health. Dr. Lynch reported having no relevant financial disclosures.

dbrunk@frontlinemedcom.com

NEW ORLEANS – Underserved African Americans with type 2 diabetes mellitus who participated in a year-long intensive self-management program did not experience sustained serum glucose control, compared with a control group receiving only two diabetes education classes.

“Relative to non-Hispanic whites, African Americans with type 2 diabetes experience more diabetes-related complications and higher rates of diabetes hospitalization,” lead study author Elizabeth B. Lynch, Ph.D., said at the annual scientific sessions of the American Diabetes Association. “These disparities are even greater for underserved disadvantaged African American populations.”

Dr. Lynch, a psychologist who directs the section of community health in the department of preventive medicine at Rush University Medical Center, Chicago, noted that several self-management interventions for diabetes have demonstrated efficacy at improving glucose control at 6 months. “However, there have not been any diabetes self-management interventions specifically targeting African Americans that have achieved sustained blood glucose control,” she said.

In a trial known as Lifestyle Intervention Through Food and Exercise (LIFE), the researchers examined the effect of a group-based intervention on glucose control at 12 months in a population of low-income African Americans. The intervention components consisted of cognitively tailored nutrition education taught by a registered dietitian, behavioral modification, social support, and peer support. “This education curriculum was based on a series of studies that were done using cognitive anthropological methods with low-income African Americans looking at beliefs and knowledge about the relationship between food and health,” Dr. Lynch said. “We used those studies to design an intervention with the aim of reducing cognitive load among participants when they’re learning new information about nutrition, so essentially making the information easier for people to understand.” Behavioral modification techniques included goal setting, self-monitoring, and problem solving. “We also had social support, and there was a peer supporter who was an individual from the community with type 2 diabetes who was assigned to each of the participants and called them on a regular basis to check in with them on their goals and encourage them,” she said.

The LIFE program consisted of 20 group sessions in the first 6 months and 8 sessions in the second 6 months, while a control group received 2 group-based education classes in the first 6 months only. The researchers conducted assessments at baseline, 6 months, and 12 months.

Individuals were eligible for the trial if they were African American, were a patient of a community clinic affiliated with Cook County Healthcare System, had a clinical diagnosis of type 2 diabetes, and had a hemoglobin A_1c level of 7% or greater. Of 1,403 initially screened for the trial, 603 were found to be eligible. Of these, 211 were randomized and enrolled: 106 to the treatment group and 105 to the control group. There was 94% follow-up at 6 and 12 months.

At baseline, the mean age of study participants was 55 years, 70% were female, 46% had a high school education or less, 60% had an annual income of less than $24,000, 65% were uninsured, and 39% had limited health literacy. Baseline food intake as reported by two 24-hour food recalls consisted of a diet high in saturated fat and low in fiber, with a moderate intake of carbohydrates and underconsumption of fruits, vegetables, and dairy products. The baseline level of daily physical activity as measured by accelerometry revealed sedentary activity that exceeded 7 hours per day, 3,614 steps per day, and only 14 minutes per day of moderate-level activity. Study enrollees had a baseline HbA_1c level of 9% and a diabetes duration of 11 years; 45% used insulin, and 48% had poor medication adherence. Their mean body mass index was 35.6 kg/m², and 91% had hypertension.

More than half of individuals in the intervention group attended each of the 20 group sessions, and 90% attended at least 1. At the same time, 68% of individuals in the control group attended both educational sessions. Dr. Lynch reported that compared with the control group, the intervention group had a significantly greater reduction in HbA_1c at 6 months (–0.76 vs. –0.21, respectively; P = .026) but not at 12 months (–0.63 vs. –0.45; P = .47). In addition, a higher percentage of individuals in the treatment group had a 0.5% or more decline in HbA_1c level at 6 months (63% vs. 42%, P = .005) but not at 12 months (53% vs. 51%, P = .89). The fact that the control group also had a reduction in HbA_1c presented a conundrum for the researchers. “One possible explanation for the decrease in A_1c in the control group is that medication adherence increased in this group, relative to the intervention group,” Dr. Lynch explained in a press release. “Additional research is needed to identify the most effective strategies to achieve sustained A_1c control in African Americans with type 2 diabetes.”

No changes were observed in blood pressure, weight, or physical activity over the course of 12 months in either group.

Although LIFE lacked a third study arm that received usual care, one possible implication of the current findings “may be that diabetes education of any type may be helpful in improving glycemic control, especially in a population that does not normally receive any education,” she said. “Medication adherence may be an easier and more effective strategy to improve glycemic control in this population.”

LIFE was supported by grants from the National Institutes of Health. Dr. Lynch reported having no relevant financial disclosures.

dbrunk@frontlinemedcom.com