Randomized Controlled Trial

. 2018 May 9;18(1):25.

doi: 10.1186/s12893-018-0358-7.

A dissonance-based intervention for women post roux-en-Y gastric bypass surgery aiming at improving quality of life and physical activity 24 months after surgery: study protocol for a randomized controlled trial

Fanny Sellberg¹, Sofie Possmark², Ata Ghaderi³, Erik Näslund⁴, Mikaela Willmer⁵, Per Tynelius^{2

6}, Anders Thorell^{7

8}, Magnus Sundbom⁹, Joanna Uddén^{10

11}, Eva Szabo¹², Daniel Berglind²

Affiliations

¹ Department of Public Health Sciences, Karolinska Institutet, K9, Social Medicin, SE-171 77, Stockholm, Sweden. fanny.sellberg@ki.se.
² Department of Public Health Sciences, Karolinska Institutet, K9, Social Medicin, SE-171 77, Stockholm, Sweden.
³ Department of Clinical Neuroscience, Karolinska Institutet, SE-171 77, Stockholm, Sweden.
⁴ Division of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.
⁵ Department of Health and Caring Sciences, University of Gävle, SE-801 76, Gävle, Sweden.
⁶ Centre for Epidemiology and Community Medicine, Stockholm County Council, Box 45436, SE-104 31, Stockholm, Sweden.
⁷ Department of Clinical Science at Danderyd Hospital, Karolinska Institutet, SE-116 91, Stockholm, Sweden.
⁸ Department of Surgery, Ersta Hospital, SE-116 91, Stockholm, Sweden.
⁹ Department of Surgical Sciences, Uppsala University, SE-751 85, Uppsala, Sweden.
¹⁰ Department of Medicine, Karolinska Institutet, SE-141 86, Stockholm, Sweden.
¹¹ Department of Endocrine and Obesity, Capio st Görans Hospital, SE-141 86, Stockholm, Sweden.
¹² Department of Surgery, Faculty of Medicine and Health, Örebro University, SE-701 85, Örebro, Sweden.

PMID: 29743040
PMCID: PMC5944022
DOI: 10.1186/s12893-018-0358-7

Randomized Controlled Trial

A dissonance-based intervention for women post roux-en-Y gastric bypass surgery aiming at improving quality of life and physical activity 24 months after surgery: study protocol for a randomized controlled trial

Fanny Sellberg et al. BMC Surg. 2018.

. 2018 May 9;18(1):25.

doi: 10.1186/s12893-018-0358-7.

Authors

Affiliations

¹ Department of Public Health Sciences, Karolinska Institutet, K9, Social Medicin, SE-171 77, Stockholm, Sweden. fanny.sellberg@ki.se.
² Department of Public Health Sciences, Karolinska Institutet, K9, Social Medicin, SE-171 77, Stockholm, Sweden.
³ Department of Clinical Neuroscience, Karolinska Institutet, SE-171 77, Stockholm, Sweden.
⁴ Division of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, SE-182 88, Stockholm, Sweden.
⁵ Department of Health and Caring Sciences, University of Gävle, SE-801 76, Gävle, Sweden.
⁶ Centre for Epidemiology and Community Medicine, Stockholm County Council, Box 45436, SE-104 31, Stockholm, Sweden.
⁷ Department of Clinical Science at Danderyd Hospital, Karolinska Institutet, SE-116 91, Stockholm, Sweden.
⁸ Department of Surgery, Ersta Hospital, SE-116 91, Stockholm, Sweden.
⁹ Department of Surgical Sciences, Uppsala University, SE-751 85, Uppsala, Sweden.
¹⁰ Department of Medicine, Karolinska Institutet, SE-141 86, Stockholm, Sweden.
¹¹ Department of Endocrine and Obesity, Capio st Görans Hospital, SE-141 86, Stockholm, Sweden.
¹² Department of Surgery, Faculty of Medicine and Health, Örebro University, SE-701 85, Örebro, Sweden.

PMID: 29743040
PMCID: PMC5944022
DOI: 10.1186/s12893-018-0358-7

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: The trial was registered on February 23th 2015 with registration number ISRCTN16417174 .

Keywords: Bariatric surgery; Dissonance-based; Intervention; Physical activity; Quality of life; RCT; Roux-en-Y gastric bypass.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

All the participating hospitals obtained approval from the Stockholm Regional Ethical Review Board (Dnr: 2013/1847–31/2, 2014/2237–32 & 2015/1647–32), and all study participants provided written consent. Additionally were information sheets and informed consent approved by the Stockholm Regional Ethical Review Board (Dnr: 2015/0082–32).

Consent for publication

Not applicable (this article does not contain any identifying data).

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

**Fig. 1**
Flowchart of enrollment and randomization

See this image and copyright information in PMC

Cited by

Meeting physical activity recommendations is associated with health-related quality of life in women before and after Roux-en-Y gastric bypass surgery.
Sellberg F, Possmark S, Willmer M, Tynelius P, Persson M, Berglind D. Sellberg F, et al. Qual Life Res. 2019 Jun;28(6):1497-1507. doi: 10.1007/s11136-019-02120-0. Epub 2019 Feb 5. Qual Life Res. 2019. PMID: 30721385 Free PMC article.
Physical activity in women attending a dissonance-based intervention after Roux-en-Y Gastric Bypass: A 2-year follow-up of a randomized controlled trial.
Possmark S, Sellberg F, Ghaderi A, Tynelius P, Willmer M, Rasmussen F, Persson M, Berglind D. Possmark S, et al. PLoS One. 2021 Nov 4;16(11):e0255556. doi: 10.1371/journal.pone.0255556. eCollection 2021. PLoS One. 2021. PMID: 34735452 Free PMC article. Clinical Trial.
A systematic review of interventions to increase physical activity and reduce sedentary behaviour following bariatric surgery.
James JD, Hardeman W, Goodall M, Eborall H, Sprung VS, Bonnett LJ, Wilding JPH. James JD, et al. Physiotherapy. 2022 Jun;115:1-17. doi: 10.1016/j.physio.2021.10.002. Epub 2021 Oct 19. Physiotherapy. 2022. PMID: 35091180 Free PMC article.

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A dissonance-based intervention for women post roux-en-Y gastric bypass surgery aiming at improving quality of life and physical activity 24 months after surgery: study protocol for a randomized controlled trial

Affiliations

A dissonance-based intervention for women post roux-en-Y gastric bypass surgery aiming at improving quality of life and physical activity 24 months after surgery: study protocol for a randomized controlled trial

Authors

Affiliations

Abstract

Conflict of interest statement

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

Figures

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Cited by

References

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