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| Randomised controlled trial evaluating the effectiveness of behavioural interventions to modify cardiovascular risk factors in men and women with impaired glucose tolerance: outcomes at 6 month |
| Oldroyd JC, Unwin NC, White M, Imrie K, Mathers JC, Alberti KGMM |
| Diabetes Research and Clinical Practice 2001 Apr;52(1):29-43 |
| clinical trial |
| 7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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AIMS: To evaluate the efficacy of interventions to promote a healthy diet and physical activity in people with impaired glucose tolerance (IGT). METHODS: A randomised controlled trial in Newcastle upon Tyne, UK, 1995-98. Participants included 67 adults (38 men; 29 women) aged 24-75 years with IGT. The intervention consisted of regular diet and physical activity counselling based on the stages of change model. Main outcome measures were changes between baseline and 6 months in nutrient intake; physical activity; anthropometric and physiological measurements including serum lipids; glucose tolerance; insulin sensitivity. RESULTS: The difference in change in total fat consumption was significant between intervention and control groups (difference -21.8 (95% confidence interval (CI) -37.8 to -5.8) g/day, p = 0.008). A significantly larger proportion of intervention participants reported taking up vigorous activity than controls (difference 30.1% (95% CI 4.3 to 52.7), p = 0.021). The change in body mass index was significantly different between groups (difference -0.95 (95% CI -1.5 to -0.4) kg/m2, p = 0.001). There was no significant difference in change in mean 2-h plasma glucose between groups (difference -0.19 (95% CI -1.1 to 0.71) mmol/l, NS) or in serum cholesterol (difference 0.02 (95% CI -0.26 to 0.31) mmol/l, NS). The difference in change in fasting serum insulin between groups was significant (difference -3.4 (95% CI -5.8 to -1.1) mU/l, p = 0.005). CONCLUSIONS: After 6 months of intensive lifestyle intervention in participants with IGT, there were changes in diet and physical activity, some cardiovascular risk factors and insulin sensitivity, but not glucose tolerance. Further follow-up is in progress to investigate whether these changes are sustained or augmented over 2 years.
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