Testing the effectiveness of a self-efficacy based exercise intervention for inactive people with type 2 diabetes mellitus: design of a controlled clinical trial

Marion Mp Van Der Heijden,François Pouwer,Victor Jm Pop,Arnold C Romeijnders

doi:10.1186/1471-2458-12-331

Marion Mp Van Der Heijden, François Pouwer + Show 2 more

Open Access

https://doi.org/10.1186/1471-2458-12-331

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Abstract

BackgroundSufficient exercise is important for people with Type 2 Diabetes Mellitus (T2DM), as it can prevent future health problems. Despite, it is estimated that only 30-40% of people with T2DM are sufficiently active. One of the psychosocial constructs that is believed to influence physical activity behaviour, is exercise self-efficacy. The goal of this study is to evaluate a patient-tailored exercise intervention for people with T2DM that takes exercise self-efficacy into account.Methods/DesignThis study is conducted as a non-randomized controlled clinical trial. Patients are eligible when they are diagnosed with T2DM, exercise less than advised in the ADA guideline of 150 min/week of moderate-intensity aerobic physical activity, have an BMI >25 and are between 18 and 80 years old. Recruitment takes place at a Primary care organization of general practitioners and practice nurses in the south of the Netherlands.Participants are allocated to three groups: An advice intervention -for participants with a high exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention, an intensive intervention -for participants with a low exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention accomplished by a group based intervention, and a control group in which participants receive regular Dutch diabetes care. The primary outcome measure of this study is physical activity. Secondary outcome measures are health status, (symptoms of) depression, exercise self-efficacy, Body Mass Index (BMI), blood pressure and glycemic control.DiscussionWe aimed to design an intervention that can be implemented in Primary care, but also to design an easy accessible program. This study is innovative as it is -to our best knowledge- the first study that takes level of exercise self-efficacy of people with T2DM into account by means of giving extra support to those with the lowest exercise self-efficacy. If the program succeeds in increasing the amount of physical activity it can be implemented in regular primary care.Trial registrationDutch Trial Register NTR2734

Highlights

Sufficient exercise is important for people with Type 2 Diabetes Mellitus (T2DM), as it can prevent future health problems
If the program succeeds in increasing the amount of physical activity it can be implemented in regular primary care
We hypothesize that the intervention will significantly increase the level of physical activity in the intervention groups compared to the control group

Summary

Introduction

Sufficient exercise is important for people with Type 2 Diabetes Mellitus (T2DM), as it can prevent future health problems. It is estimated that only 30-40% of people with T2DM are sufficiently active. In 2000 the worldwide prevalence of diabetes mellitus was 171 million. This is expected to increase up to 366 million in 2030 [2]. 90% of the people with diabetes mellitus have type 2 diabetes mellitus (T2DM) [3]. 72% of the people with T2DM have at least one of these complications [4]. Global mortality attributable to diabetes was estimated to be 2.9 million people in 2000, 5.2% of all deaths [5]

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