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Dyson et al. 997 56,280

Wing et al. 19985' Ic

Fasting Hyperglycemia Study (FHS) II

(Lifestyle) UK and France; 227 persons aged 30-65 (x= 50yrs); factorial design with sulfonylurea; follow-up 1 year. Outcome: diabetes

Pittsburgh, PA, USA

154 overweight nondiabetics aged 40-55 years (x = 46) with 1 + diabetic parent; follow-up up to 2 years. 72/154 with IGT at baseline. Outcome: diabetes

Basic lifestyle (N = 116); Reinforced lifestyle

(N = 111): low-fat diet, increased fiber, hypocaloric if BMI >22; aerobic physical activity given once a year in basic group, and every 3 months in reinforced group

Diet (N = 37): low fat, low calorie. Exercise (N = 37): 1500 Kcal/wk moderate exercise. Diet + exercise (N = 40): combination of other interventions. Control (N = 40): written material

Narayan et al. 199860

Pima Indians, AZ, USA

95 overweight nondiabetic subjects aged 25-54 years (x = 33.5), follow-up 1 year; pilot study. Outcome: glucose

Action (N = 48): diet and exercise advice without weight loss goals. Pride (N = 47): Pima culture, limited diet and activity, information. Observational control (N = 22)

Basic: 1.5 kg weight loss at 3 months, no change at 1 year; no changes in percentage with diabetes, glucose intolerance, or high BP. Reinforced: weight loss similar to basic group; no changes in percentage with diabetes, glucose intolerance or high BP; fitness, insulin sensitivity, TGs significantly improved 6 months: decreases in F glucose, F insulin in D and D + E groups; also in lipids, BP. 12 months: No change in F glucose between groups, though weight loss maintained in D, D + E at 60% and 72% of 6 month levels. 24 months: Control: 7% with diabetes; D: 30.3%; E: 14%; D + E: 15.6%. FPG, OGTT, weight loss did not differ between groups. In multivariate model, —4.5 kg weight loss (4.5% of initial weight) predicted RR of 0.696 (0.526-0.865) for type 2 DM among NGT; RR = 0.744 (0.592-0.897) among IGT subjects. No differences in type 2 diabetes between intervention groups, once weight loss accounted for Action: 29% with 2 h glucose

>7.8 mM/L; BMI ( + 0.9), BP, 2 h glucose ( + 1.3mM) and insulin (+8.8 pM) increased more than Pride. Pride: 11% with 2 h glucose >7.8 mM/L; decreased waist circumference; no increase in 2 h glucose (0.0), less increase in fasting and 2 h insulin ( + 3.2 pM), BMI (+0.5). Observational control: intermediate weight gain and glucose changes between two intervention groups

Dropouts 18% in reinforced advice, 7% in basic advice at 1 year. Randomization schedule not masked

Groups similar at baseline. Dropouts: 6 months, 15%; 12 months, 22%; 24 months, 16%. Class attendance averaged only 27 % in last 18 months. ^ Little change in diet or exercise at 24 c^ months between groups. Much of the cohort not exposed to intervention o during the last 18 months. Not blinded; allocation not said to be <0

masked. Intention to treat analysis used on persons attending follow-up

Class-based diet and exercise lifestyle intervention not effective; focus on cultural approaches and barriers to participation may be more successful. Blinded outcomes, intention to treat analysis; poor compliance with interventions (17-25% attendance at classes), but very low dropout rates for 6,12 month evaluations (2-3%)

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