Effect of an intensive metabolic control lifestyle intervention in type-2 diabetes patients

https://doi.org/10.1016/j.pec.2016.01.017Get rights and content

Highlights

  • A clinical trial was performed to evaluate 2 methods for the treatment of type 2 diabetes.

  • Intensive intervention (behavior change) was compared to educational intervention.

  • No changes were made to their drug treatment during the follow/up.

  • Both groups showed significant reductions in body weight and A1c levels.

  • Larger changes in A1c weight and diastolic BP were seen in intensive intervention.

Abstract

Objective

To evaluate the effectiveness of an intensive lifestyle intervention on metabolic control in patients with type 2 diabetes.

Methods

199 patients recently diagnosed with type 2 diabetes, with lack of metabolic control and overweight/obesity, were randomly assigned to intensive lifestyle intervention or collaborative educational program alone, with 6 months of follow-up. Intervention included 150 min of physical activity a week to reduce body weight by 7%. Both groups received 16 sessions on behavior modification over the course of the 6 months. Measurements were taken at baseline, 3 and 6 months. Results were analyzed and compared.

Results

Significant weight loss was achieved by both groups, with greater loss in the intervention group. Those with lower baseline A1c appeared to benefit more from the educational program than intensive intervention over time.

Conclusions

Both interventions produced positive if modest changes in metabolic control. These results suggest that, for weight loss and control of A1c, an intensive intervention may be more effective.

Practice Implications

The current study demonstrates the value of a systematic application of behavior modification and self-care techniques in the treatment of type 2 diabetes. It demonstrates the importance of intensive, all-inclusive treatment, and of attention to individual concerns.

Introduction

Diabetes is the main cause of death in Mexico; the Mexican Institute of Social Security lists diabetes as the cause of death in one of five death certificates [1]. Most of these deaths are associated with chronic complications [2], which are preventable when treatment is focused on meeting strict therapeutic goals: A1c < 7.0%, LDL cholesterol <100 mg/dl, and blood pressure < 130/80 mmHg.

The DCCT and UKPDS studies have demonstrated that a strict glycemic control can reduce microvascular complications, and, despite the difficulty in maintaining the therapeutic goal of A1c < 7% for more than 10 years, those who have attained a strict glycemic control during its initial stages have fewer complications than those who have not, with this effect lasting for 20 years [3]. The Advance study showed that even in patients that had already lived for 8 years with diabetes, reduction of A1c from 7.3% to 6.5% resulted in a 30% decrease in microvascular complications [4]. Lowering blood pressure is associated with a reduced risk of CVD (34–69%) and of macro and micro vascular complications (26–46%) [4].

Diet and exercise are key in the metabolic control necessary for prevention of complications and the management of the disease [5]. Clinical trials have demonstrated that an appropriate diet can lower A1c between 1 and 2% [6], reduce the use of oral hypoglucemiants and lower both LDL-c levels and blood pressure [7]. Moderate physical activity (30 min every day) is associated with a reduction of 30–50% in the risk of developing diabetes and CVD [8]. In addition, exercise has a positive effect on mood, reducing anxiety, depressive symptoms and blood pressure, favoring insulin sensitivity and helping in the maintenance of weight loss [9].

Life-style interventions comprising both physical activity programs and nutritional interventions have demonstrated effectiveness in the improvement of glycemic control [10], the reduction of body weight, insulin resistance, blood pressure, dyslipidemia and inflammation, and in the increase of insulin sensitivity [11].

In the Look AHEAD study [12], after one year, the intensive lifestyle intervention group exhibited an 8.6% reduction in initial body weight compared to the 0.7% exhibited by the control group. The intensive lifestyle intervention group exhibited improved outcomes for weight loss, A1c concentration (6.6% vs 7.25%) and the reduction of cardiovascular risk factors.

The Steno 2 trial evaluated the effect of a combined intensive treatment on A1c, blood pressure and cholesterol. It demonstrated that after 14 years [13], there was a 59% reduction of the incidence of complications and mortality compared with the usual treatment of type 2 diabetes patients.

The benefits of intensive interventions have led medical practitioners to emphasize these in the control of the disease. However, it has been shown that few patients attain the goals in these interventions due to a myriad of different causes that include the use of paternalistic health care models, clinical inertia and limited appointment times, restricted access to education and permanent support, erratic detection and attention of the specific needs of each patient, non-pro-active patients, difficult maintenance of the individual’s motivation and the incapacity to modify behavior in the long term [14]. In general, studies that include intensive treatment goals have reported that 50–80% of their patients achieve one or two treatment goals; this is reduced to 12% if three goals are considered [15].

Additional benefits of intensive lifestyle interventions include the fact that they are effective in different ethnic and cultural groups; their goals are secure, attainable and can be maintained over time, and they present an attractive cost-benefit for implementation [16], because they promote health behaviors with multiple benefits.

The objective of this study was to test the efficacy of an intensive lifestyle intervention (IIEV) in groups of diabetes patients that receive medical care from general practice clinics (family medicine units of the Mexican social security system). The collaborative education model (COED) was used as a control group.

Section snippets

Research design and methods

A controlled clinical trial was performed using two parallel groups with repeated measurements, random treatment assignment and double-blind evaluation of results. The trial was carried out in eight Family Medicine Units (UMF) in Mexico City. Patients were required to have a recent type 2 diabetes diagnosis (<3 years) along with obesity/overweight and a lack of glycemic control. Patients with chronic complications or a history of severe hypoglycemia, mental disease or substance abuse were not

Results

Table 1 indicates the baseline characteristics for the two groups, and shows no significant differences.

Table 2 shows the comparison between baseline and final measurements, with the respective Δ.

Discussion and conclusion

In our study, for both weight and the A1c, significantly lower values were achieved with the intensive intervention (IIEV) when compared with the educational one (COED). Twice as many patients in the IIEV group reached a weight reduction target of at least 5% of body weight (26% of patients in IIEV; 13% of patients in COED). We attribute this effect to the characteristics of the intensive intervention. Firstly, the IIEV goals are set from the first session. This allows patients to focus their

Author contributions

Mireya Gamiochipi designed and carried out the study and wrote the manuscript; Miguel Cruz carried out the study and approved the final manuscript; Jesús Kumate participated in the design of the study, analyzed the discussion and approved the final manuscript; N. Wacher designed the study, analyzed data and reviewed the manuscript and approved the final submission; and the DIMSS Study Group carried out the study and approved the final manuscript.

Acknowledgements

The authors report no conflicts of interest. This work was funded by Research Grant 2004/497 from Fondo de Fomento a la Investigación (FOFOI)/IMSS.

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