Sellberg Fanny, Possmark Sofie, Ghaderi Ata, Näslund Erik, Willmer Mikaela, Tynelius Per, Thorell Anders, Sundbom Magnus, Uddén Joanna, Szabo Eva, Berglind Daniel
Department of Public Health Sciences, Karolinska Institutet, K9, Social Medicin, SE-171 77, Stockholm, Sweden.
Department of Clinical Neuroscience, Karolinska Institutet, SE-171 77, Stockholm, Sweden.
BMC Surg. 2018 May 9;18(1):25. doi: 10.1186/s12893-018-0358-7.
Roux-en-Y gastric bypass (RYGB) surgery is the most common bariatric procedure in Sweden and results in substantial weight loss. Approximately one year post-surgery weight regain for these patient are common, followed by a decrease in health related quality of life (HRQoL) and physical activity (PA). Our aim is to investigate the effects of a dissonance-based intervention on HRQoL, PA and other health-related behaviors in female RYGB patients 24 months after surgery. We are not aware of any previous RCT that has investigated the effects of a similar intervention targeting health behaviors after RYGB.
The ongoing RCT, the "WELL-GBP"-trial (wellbeing after gastric bypass), is a dissonance-based intervention for female RYGB patients conducted at five hospitals in Sweden. The participants are randomized to either control group receiving usual follow-up care, or to receive an intervention consisting of four group sessions three months post-surgery during which a modified version of the Stice dissonance-based intervention model is used. The sessions are held at the hospitals, and topics discussed are PA, eating behavior, social and intimate relationships. All participants are asked to complete questionnaires measuring HRQoL and other health-related behaviors and wear an accelerometer for seven days before surgery and at six months, one year and two years after surgery. The intention to treat and per protocol analysis will focus on differences between the intervention and control group from pre-surgery assessments to follow-up assessments at 24 months after RYGB. Patients' baseline characteristics are presented in this protocol paper.
A total of 259 RYGB female patients has been enrolled in the "WELL-GBP"-trial, of which 156 women have been randomized to receive the intervention and 103 women to control group. The trial is conducted within a Swedish health care setting where female RYGB patients from diverse geographical areas are represented. Our results may, therefore, be representative for female RYGB patients in the country as a whole. If the intervention is effective, implementation within the Swedish health care system is possible within the near future.
The trial was registered on February 23th 2015 with registration number ISRCTN16417174 .
胃旁路手术（RYGB）是瑞典最常见的减肥手术，能显著减轻体重。术后约一年，这些患者体重反弹很常见，随后与健康相关的生活质量（HRQoL）和身体活动（PA）会下降。我们的目的是研究基于认知失调的干预措施对RYGB女性患者术后24个月时的HRQoL、PA及其他健康相关行为的影响。我们不知道之前有任何随机对照试验研究过针对RYGB术后健康行为的类似干预措施的效果。
正在进行的随机对照试验“WELL - GBP”试验（胃旁路术后的幸福感），是一项针对瑞典五家医院的RYGB女性患者的基于认知失调的干预措施。参与者被随机分为接受常规随访护理的对照组，或接受术后三个月由四节小组课程组成的干预组，干预过程中使用基于斯泰斯认知失调干预模型的改良版。课程在医院进行，讨论的主题包括PA、饮食行为、社交和亲密关系。所有参与者都被要求完成测量HRQoL和其他健康相关行为的问卷，并在手术前以及术后六个月、一年和两年佩戴加速度计七天。意向性分析和符合方案分析将聚焦于RYGB术后24个月时干预组与对照组从术前评估到随访评估的差异。本方案论文展示了患者的基线特征。
共有259名RYGB女性患者参与了“WELL - GBP”试验，其中156名女性被随机分配接受干预，103名女性被分配到对照组。该试验在瑞典医疗环境中进行，涵盖了来自不同地理区域的RYGB女性患者。因此，我们的结果可能代表了瑞典全国的RYGB女性患者。如果该干预措施有效，在不久的将来有可能在瑞典医疗系统内实施。
该试验于2015年2月23日注册，注册号为ISRCTN16417174 。
