Open randomised trial of intermittent very low energy diet together with nicotine gum for stopping smoking in women who gained weight in previous attempts to quit

OBJECTIVE: To determine whether attempts to prevent weight gain will increase success rates for stopping smoking. DESIGN: 16 week, open, randomised study with 1 year follow up. SETTING: Obesity unit. SUBJECTS: 287 female smokers who had quit smoking before but started again because of weight concerns. INTERVENTION: Combination of a standard smoking cessation programme with nicotine gum and a behavioural weight control programme including a very low energy diet. A control group was treated with the identical programme but without the diet. MAIN OUTCOME MEASURE: Sustained cessation of smoking. RESULTS: After 16 weeks, 68/137 (50%) women had stopped smoking in the diet group versus 53/150 (35%) in the control group (P=0.01). Among these women, weight fell by mean 2.1 (95% confidence interval 2.9 to 1.3) kg in the diet group but increased by 1.6 (0.9 to 2.3) kg in the control group (P<0.001). After 1 year the success rates in the diet and control groups were 38/137 (28%) and 24/150 (16%) respectively (P<0.05), but there was no statistical difference in weight gain. CONCLUSIONS: Combining the smoking cessation programme with an intervention to control weight helped women to stop smoking and control weight.