In comparison to the control group the intervention was not successful at reducing weight gain. Those successful at stopping smoking gained 3.9
kg, which was more than the 2.5
kg women attempting smoking cessation are reportedly willing to tolerate [18
] but less than the 5
kg at 6
months reported in other research [9
]. Continued professional/therapist contact has been shown to improve weight management and smoking cessation outcomes [19
]. Interviews with intervention participants highlighted that the support and encouragement they received from both their fellow group members and advisors had helped with both weight management and quit attempt. This continued contact may have reduced anxieties regarding weight gain and thus encouraged cessation maintenance despite weight gain.
The intervention focussed on encouraging participants, who were likely to experience increased appetite and food cravings to choose healthier, less energy dense foods which would minimise weight gain. While between-group differences in changes in reported eating habits were non-significant there was evidence of improved eating habits compared to baseline, in the intervention group. Fruit and vegetable consumption improved significantly suggesting that fruit was eaten in place of some higher energy snacks. Consumption of breakfast cereals also improved. Previous research has shown that weight gain is less in adults who eat breakfast [21
]. Both these changes suggest that efforts were being made by participants to adopt healthier eating patterns.
Interview data shows that some viewed changes to diet and physical activity only necessary if they were successful at stopping smoking and therefore at risk of weight gain. Failure to give up smoking may have led some participants to abandon efforts to change their diet or physical activity level.
We have demonstrated that it is possible, after appropriate brief training, for those with no prior formal nutrition training to deliver a nutrition and lifestyle intervention. Training existing staff to deliver additional information to those attempting smoking did not incur excessive costs. The use of existing staff would allow diet and lifestyle aspects to be integrated into the existing smoking cessation programme and avoid the additional expense of employing specialists such as dietitians or nutritionists. Individuals attempting smoking cessation develop a rapport with the cessation advisor taking the group and this relationship may increase the likelihood of dietary advice being acknowledged and implemented. Whilst a dietitian may have more in-depth knowledge it is unlikely that at dietitian would be able to routinely attend all smoking cessation programme sessions. Utilisation of existing personnel was also important to allow the results to be sustainable and transferable for national application.
Uptake from cessation classes into this study was less than hoped for and this may reflect that for some smoking cessation was their sole objective and they were not considering, or could not consider other concomitant lifestyle changes. It is possible that those who chose to join the study were not entirely representative of all those attempting smoking cessation, but they were at least a sizeable proportion. Consideration must also be given to the extra time commitment required of study participants.
Whilst uptake to the study was lower than hoped for, attrition was lower than the anticipated 75%. Research in the field of weight management has suggested that lower attrition rates are representative of some form of success [23
]. The lower attrition rate in the present study may thus indicate success in that for participants the programme fulfilled a role by providing additional support and assistance for them whilst attempting lifestyle changes.
The present study was not powered to investigate effects on cessation rates however the results suggest that smoking cessation was not compromised by the intervention. Comparison of the 6
week cessation rate for intervention participant with those of an earlier observation study carried out in Glasgow [24
] showed those of the present study to be better (57% vs. 36%, p
0.001). Improved cessation rates in the present study may in part reflect increased use of varenicline. Most study participants (59%) chose varenicline to aid their quit attempt, compared to only 13% of subjects in the study by Bauld and colleagues [24
]. Cessation rates for both groups deteriorated between week 6 and 24 and it is reasonable to assume the same pattern is likely throughout Glasgow. However at week 24 the cessation rate in intervention participants was 34%, much better than expected and close to the week 4 cessation rate reported for the Glasgow wide service. This suggests that participation in the intervention arm of the study may have conferred some benefit in terms of maintenance of cessation. Improved cessation rates may not result directly from the dietary intervention per se but to other factors such as continued professional/therapist contact and reduced anxiety regarding weight gain. Interview data supports this. Intervention participants were conscious that exhaled CO levels would be checked and this provided motivation to refrain from smoking as a high reading, they felt, would be interpreted as failure and would let the group down. Remaining abstinent they felt also provided encouragement to the other group members.
Although between group differences in quit rates were not statistically significant in the present study the higher quit rate in intervention participants would be compatible with a real effect. Reverse power analysis using the present data showed that a study to prove an effect of this size would require 165 per group using completer data, and 539 per group using sensitivity analysis data.
The figures provided (Table ) are not precise calculations but are intended to be indicative of the relatively modest changes in weight that would be required given the level of costs. This may suggest that using a different protocol or providing the intervention to a different group may well be cost-effective. This supports the argument that the “non-significant” difference in the primary outcome measure should not end research in this area. The figures should be used with caution and as a starting point for debate only, for several reasons. First, they do not consider any cost savings from avoiding weight-related diseases. For example, if we included the chances of developing type 2 diabetes and included the lifetime costs of this illness the required weight reductions would fall. In addition, we have not considered that controlling weight may help people to stop smoking – any QALY gains from people helped to stop smoking have also not been included. There may also be benefits that have not been considered by this research, such as the spill-over effects of education in diet and exercise on the remainder of the family. Any benefits of this type would also help to make the programme cost-effective
Recruitment to research studies is likely to attract more motivated volunteers. The observation that weight gain in our control participants was similar to intervention participants may reflect their willingness or interest in making lifestyle changes in addition to smoking cessation. The qualitative data support this suggestion. The majority of control participants interviewed reported setting themselves diet and or physical activity goals and had sought help from other sources to achieve these.
The advisors who participated in the study and delivered the intervention also conducted the smoking cessation classes for control participants. Whilst aware of the need to avoid contamination of control classes it is possible that issues regarding weight and diet were answered in more depth, thus influencing the behaviour of control participants. It is not possible to quantify this potential contamination, but in retrospect, may have been avoided had advisors who had not been given additional training been recruited and allocated to control classes. However this would have been difficult in practice as randomisation of classes did not take place until week 3 and participants had already developed a rapport with the advisor running that class. Changing advisor at this point may have undermined attempts at smoking cessation.
Dietary practices were assessed using the Dietary Targets Monitor, a short food frequency questionnaire developed for use in the 1995 Scottish Health Survey. Formal comparison between this short questionnaire and a fuller and widely used food frequency questionnaire [14
] showed that the dietary targets monitor had the capability to monitor intakes for changes towards national dietary targets for key foods and nutrients but did not very accurately predict results for some food groups when the study numbers were below 300. All methods of assessing dietary intake have limitations including mis-reporting [25
]. For the present study it was important to identify a tool which was acceptable to the study population and not too onerous to complete, as this may have had adverse effects on retention rates. For these reasons and to gather as comprehensive a data set as possible the dietary targets monitor was used.