Background and aims: The increasing rate of obesity is evident in both the world in general and in Norway. The consequences of obesity are well documented, including diabetes mellitus (DM) type 2, cardiovascular diseases, social stigma, and shortened life expectancy. Bariatric surgery is the most effective long-term successful treatment for the morbidly obese and the only documented treatment to maintain a substantial weight loss in this group over time. However, weight regain after surgery is a well recognized problem, also at Oslo University Hospital (OUH) Aker. Weight loss after bariatric surgery has a major positive impact on both somatic and mental health. Simultaneously, weight regain is shown to deteriorate these positive effects. Thus, an adequate follow-up regimen to avoid substantial weight regain is important to establish. Health related quality of life (HRQoL) is known to be poorer in morbidly obese subjects compared to the population norm, to improve with a significant weight loss and to deteriorate in association with the magnitude of weight regain. The purpose of the present study was to investigate whether additional follow-up prevents or lessen the degree of weight regain and whether it has a positive effect on HRQoL compared to controls who receive usual postoperative care.
Subjects and methods: Recruitment letters were sent to 714 eligible participants 14 months – 2 ½ years after Roux-en-Y gastric bypass (RYGBP) surgery from 2008 – 2010 for participation in a two-year study. Participants were randomized into a control and an intervention group according to sex and percentage of excess weight loss (EWL).The intervention was mainly based on group meetings, 16 in total. Results are based on data from individual study visits at baseline, 4 and 24 months. Food diaries to assess energy intake and the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) questionnaire to assess HRQoL were collected together with measures of weight and waist circumference. The study was approved by The Privacy Ombudsman, The Regional Committee of Medical Ethics, and Biohealth Norway.
Results: A total of 166 participants (23.2%) were recruited to the study. The completion rate was 93.4% at the 4 month visit and 83.0% at the 24 month visit. From baseline to the 4 month visit, the intervention group showed a significant weight increase (p-value = 0.007), whereas a tendency to weight increase was seen from baseline to 24 months (p-value = 0.08). There was no significant difference in weight or waist circumference between the control and intervention group at 4 months or at 24 months (p-values > 0.05). There was no difference in energy intake between the two groups at 24 months (p-value = 0.96) and there was no significant association between change in energy intake and change in weight (p-value = 0.45). HRQoL analyses between baseline and 4 months showed that the intervention group had a tendency of decrease in the mental health measure (p-value = 0.09) whereas the control group showed a significant decrease in both the total score and the mental health measure (p-values = < 0.001 for both). No HRQoL score was statistically significant between the groups after 4 months (all p-values > 0.05). The control group had a significantly larger decline in mental health measure score than the intervention group (p-value = 0.04). No association between change in weight and change in any of the aggregated scores of the SF-36 were found (all p-values > 0.05).
Conclusion: The study subjects in both groups showed a tendency to increase their weight after 24 months of study and the control group showed a decrease in HRQoL total and mental scores. As these factors have been shown to correlate, it is important to prevent as much weight regain as possible, both concerning somatic and mental health. Future results from this study may reveal whether a group intervention should be a part of the usual care after RYGBP surgery or not.