Andrews RC, Cooper AR, Montgomery AA, et al. Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial

School of Clinical Sciences, University of Bristol, Bristol, UK.
The Lancet (Impact Factor: 45.22). 06/2011; 378(9786):129-39. DOI: 10.1016/S0140-6736(11)60442-X
Source: PubMed


Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus, but no large trials have compared interventions. We investigated the effects of diet and physical activity on blood pressure and glucose concentrations.
We did a randomised, controlled trial in southwest England in adults aged 30-80 years in whom type 2 diabetes had been diagnosed 5-8 months previously. Participants were assigned usual care (initial dietary consultation and follow-up every 6 months; control group), an intensive diet intervention (dietary consultation every 3 months with monthly nurse support), or the latter plus a pedometer-based activity programme, in a 2:5:5 ratio. The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c)) concentration and blood pressure at 6 months. Analysis was done by intention to treat. This study is registered, number ISRCTN92162869.
Of 593 eligible individuals, 99 were assigned usual care, 248 the diet regimen, and 246 diet plus activity. Outcome data were available for 587 (99%) and 579 (98%) participants at 6 and 12 months, respectively. At 6 months, glycaemic control had worsened in the control group (mean baseline HbA(1c) percentage 6·72, SD 1·02, and at 6 months 6·86, 1·02) but improved in the diet group (baseline-adjusted difference in percentage of HbA(1c) -0·28%, 95% CI -0·46 to -0·10; p=0·005) and diet plus activity group (-0·33%, -0·51 to -0·14; p<0·001). These differences persisted to 12 months, despite less use of diabetes drugs. Improvements were also seen in bodyweight and insulin resistance between the intervention and control groups. Blood pressure was similar in all groups.
An intensive diet intervention soon after diagnosis can improve glycaemic control. The addition of an activity intervention conferred no additional benefit.
Diabetes UK and the UK Department of Health.

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Available from: Debbie Sharp, May 27, 2015
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    • "This paper presents a secondary data analysis from the Early ACTivity in Diabetes (Early ACTID) study, a randomised controlled trial of physical activity and diet in the management of type 2 diabetes. This study has been described in detail previously [21]. Briefly, participants with newly diagnosed type 2 diabetes were recruited through primary care in the South West of England. "
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    ABSTRACT: Background and Aims We investigated whether objectively measured sedentary time was associated with markers of inflammation in adults with newly diagnosed type 2 diabetes. Methods and Results We studied 285 adults (184 men, 101 women, mean age 59.0 ± 9.7) who had been recruited to the Early ACTivity in Diabetes (Early ACTID) randomised controlled trial. C-reactive protein (CRP), adiponectin, soluble intracellular adhesion molecule-1 (sICAM-1), interleukin-6 (IL-6), and accelerometer-determined sedentary time and moderate-vigorous physical activity (MVPA) were measured at baseline and after six-months. Linear regression analysis was used to investigate the independent cross-sectional and longitudinal associations of sedentary time with markers of inflammation. At baseline, associations between sedentary time and IL-6 were observed in men and women, an association that was attenuated following adjustment for waist circumference. After 6 months of follow-up, sedentary time was reduced by 0.4 ± 1.2 hours per day in women, with the change in sedentary time predicting CRP at follow-up. Every hour decrease in sedentary time between baseline and six-months was associated with 24% (1, 48) lower CRP. No changes in sedentary time between baseline and 6 months were seen in men. Conclusions Higher sedentary time is associated with IL-6 in men and women with type 2 diabetes, and reducing sedentary time is associated with improved levels of CRP in women. Interventions to reduce sedentary time may help to reduce inflammation in women with type 2 diabetes.
    Full-text · Article · Jun 2014 · Nutrition Metabolism and Cardiovascular Diseases
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    • "Among the 11 included studies, 54.5% (6/11) provided adequate random sequence generation, with 2 trials using a computer generator [24,32], 2 using blocked randomization [27,30], 1 using stratified (gender and age) randomization [25], and 1 using numbered sealed envelopes [29]; 54.5% (6/11) reported proper allocation concealment, with 4 trials using sealed envelopes [24,25,27,29] and 2 using central allocation [30,32]. All studies had blinded assessment of outcomes, and described losses to follow-up and exclusions; 45.5% (5/11) carried out ITT analyses [24,25,28,29,32], whereas 54.5% (6/11) used per-protocol analyses [18,26,27,30,31,33]. "
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    ABSTRACT: BackgroundWhile step counter use has become popular among type 2 diabetes (T2D) patients, its effectiveness in increasing physical activity (PA) and improving glycemic control has been poorly defined. The aim of this meta-analysis of randomized controlled trials (RCTs) was to evaluate the association of step counter use with PA and glycemic control in T2D patients.MethodsArticles were identified by searches of PubMed, Web of Science and Cochrane Library from January 1994 to June 2013. RCTs in the English language were included, if they had assessed the effectiveness of step counters as motivating and monitoring tools in T2D patients, with reported changes in steps per day (steps/d) or glycosylated hemoglobin A1c (HbA1c), or both. Data were independently collected by 2 authors and overall estimates were made by a random-effects model.ResultsOf the 551 articles retrieved, 11 RCTs were included. Step counter use significantly increased PA by 1,822 steps/d (7 studies, 861 participants; 95% confidence interval (CI): 751 to 2,894 steps/d) in patients with T2D. Step counter use with a PA goal showed a bigger increase in PA (weighted mean difference (WMD) 3,200 steps/d, 95% CI: 2,053 to 4,347 steps/d) than without (WMD 598 steps/d, 95% CI: −65 to 1,260 steps/d). Further subgroup analysis suggested step counter use with a self-set PA goal (WMD 2,816 steps/d, 95% CI: 1,288 to 4,344 steps/d) made no difference in increasing PA from a 10,000 steps/d goal (WMD 3,820 steps/d, 95% CI: 2,702 to 4,938 steps/d). However, no significant HbA1c change was observed by step counter use (10 studies, 1,423 participants; WMD 0.02%, 95% CI: −0.08% to 0.13%), either with (WMD 0.04%, 95% CI: −0.21% to 0.30%) or without a PA goal (WMD 0.01%, 95% CI: −0.10% to 0.13%).ConclusionsStep counter use is associated with a significant increase in PA in patients with T2D. However, evidence regarding its effect in improving glycemic control remains insufficient.Trial registrationPROSPERO CRD42013005236
    Full-text · Article · Feb 2014 · BMC Medicine
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    • "Nutrition therapy interventions implemented by registered dietitians/nutritionists reduced HbA1c levels by an average of 1% to 2% (range −0.23% to −2.6%) depending on the type and duration of diabetes and the HbA1c level at implementation.1–4 For example, implementation of nutrition therapy in patients with newly diagnosed type 2 diabetes and an HbA1c of ~9% resulted in a decrease of ~2%,5 whereas persons newly diagnosed with HbA1c levels of ~6.6% experienced a decrease of 0.4%,6 both of which are significant and clinically meaningful. Even in patients with a long duration of type 2 diabetes of ~9 years and diabetes that was not optimally controlled, implementation of nutrition therapy decreased HbA1c by ~0.5%, which was significant and more cost-effective than adding a third medication.7 "
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    ABSTRACT: Current nutrition therapy recommendations for the prevention and treatment of diabetes are based on a systematic review of evidence and answer important nutrition care questions. First, is diabetes nutrition therapy effective? Clinical trials as well as systematic and Cochrane reviews report a ~1%-2% lowering of hemoglobin A1c values as well as other beneficial outcomes from nutrition therapy interventions, depending on the type and duration of diabetes and level of glycemic control. Clinical trials also provide evidence for the effectiveness of nutrition therapy in the prevention of diabetes. Second, are weight loss interventions important and when are they beneficial? Modest weight loss is important for the prevention of type 2 diabetes and early in the disease process. However, as diabetes progresses, weight loss may or may not result in beneficial glycemic and cardiovascular outcomes. Third, are there ideal percentages of macronutrients and eating patterns that apply to all persons with diabetes? There is no ideal percentage of macronutrients and a variety of eating patterns has been shown to be effective for persons with diabetes. Treatment goals, personal preferences (eg, tradition, culture, religion, health beliefs, economics), and the individual's ability and willingness to make lifestyle changes must all be considered by clinicians and/or educators when counseling and educating individuals with diabetes. A healthy eating pattern emphasizing nutrient-dense foods in appropriate portion sizes, regular physical activity, and support are priorities for all individuals with diabetes. Reduced energy intake for persons with prediabetes or type 2 diabetes as well as matching insulin to planned carbohydrate intake are intervention to be considered. Fourth, is the question of how to implement nutrition therapy interventions in clinical practice. This requires nutrition care strategies.
    Full-text · Article · Feb 2014 · Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
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