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Open Access 01-12-2016 | Study protocol

APOLO-Bari, an internet-based program for longitudinal support of bariatric surgery patients: study protocol for a randomized controlled trial

Authors: Eva M. Conceição, Paulo P. P. Machado, Ana Rita Vaz, Ana Pinto-Bastos, Sofia Ramalho, Cátia Silva, Filipa Arrojado

Published in: Trials | Issue 1/2016

Abstract

Background

Despite evidence of successful weight loss for bariatric surgery patients, some patients experience considerable weight regain over the long term. Given the strong association between post-surgery health behaviors and outcomes, aftercare intervention to address key behaviors appears to be a reasonable relapse-prevention strategy. As the burden of obesity rates increases in healthcare centers, an internet-based program appears to be a reasonable strategy for supporting bariatric surgery patients in the long term. The primary purpose of the current project is to develop and test the efficacy and perceived utility of APOLO-Bari.

Methods/design

This study is a randomized control trial, which will be conducted in two hospital centers in the North of Portugal; it includes a control group receiving treatment as usual and an intervention group receiving the APOLO-Bari program for one year in addition to treatment as usual. A total of 180 male and female participants who underwent bariatric surgery (gastric sleeve or gastric bypass surgery) for 12 to 20 months will be recruited. Both groups will complete a similar set of questionnaires at baseline, every 4 months until the end of the intervention, and at 6 and 12 months follow-up. Assessment includes anthropometric variables and psychological self-report measures. The primary outcome measure will be weight regain measured at the end of treatment, and at 6 and 12 months follow-up. The secondary aims are to test the cost-effectiveness of the intervention and to investigate psychological predictors and trajectories of weight regain. APOLO-Bari was developed to address the weight regain problem in the bariatric population by offering additional guidance to bariatric patients during the postoperative period. The program includes: (a) a psychoeducational cognitive-behavioral-based self-help manual, (b) a weekly feedback messaging system that sends a feedback statement related to information reported by the participant, and (c) interactive chat sessions scheduled with a trained psychologist in the field.

Discussion

APOLO-Bari may play an important role in broadening therapeutic reach to bariatric patients who would not otherwise have continuous support, with important implications for public health treatment.

Trial registration

Current Controlled Trials: ISRCTN37668662.

Courcoulas AP, Nicholas C, Belle S, Berk PD, Flum D, Garcia L. Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity. JAMA. 2013;310:2416–25. doi:10.1001/jama.2013.280928.PubMedPubMedCentral

Karmali S, Brar B, Shi X, Sharma AM, De Gara C, Birch DW. Weight recidivism post-bariatric surgery: a systematic review. Obes Surg. 2013;23:1922–33. doi:10.1007/s11695-013-1070-4.CrossRefPubMed

Cooper TC, Simmons EB, Webb K, Burns JL, Kushner RF. Trends in weight regain following roux-en-Y gastric bypass (RYGB) bariatric surgery. Obes Surg. 2015;25:1474–81. doi:10.1007/s11695-014-1560-z.CrossRefPubMed

White MA, Kalarchian MA, Masheb RM, Marcus MD, Grilo CM. Loss of control over eating predicts outcomes in bariatric surgery patients: a prospective 24-month follow-up study. J Clin Psychiatry. 2010;71:175–84. doi:10.4088/JCP.08m04328blu.Loss.CrossRefPubMedPubMedCentral

Digiorgi M, Rosen DJ, Choi JJ, Milone L, Schrope B, Olivero-Rivera L, et al. Re-emergence of diabetes after gastric bypass in patients with mid- to long-term follow-up. Surg Obes Relat Dis. 2010;6:249–53. doi:10.1016/j.soard.2009.09.019.CrossRefPubMed

Rudolph A, Hilbert A. Post-operative behavioural management in bariatric surgery: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2013;14:292–302. doi:10.1111/obr.12013.CrossRefPubMed

Sarwer DB, Dilks RJ, West-Smith L. Dietary intake and eating behavior after bariatric surgery: threats to weight loss maintenance and strategies for success. Surg Obes Relat Dis. 2011;7:644–51.CrossRefPubMed

Odom J, Zalesin KC, Washington TL, Miller WW, Hakmeh B, Zaremba DL, et al. Behavioral predictors of weight regain after bariatric surgery. Obes Surg. 2010;20:349–56.CrossRefPubMed

Conceição EM, Utzinger LM, Pisetsky EM. Eating disorders and problematic eating behaviours before and after bariatric surgery: characterization, assessment and association with treatment outcomes. Eur Eat Disord Rev. 2015;23(6):417–25. doi:10.1002/erv.2397.CrossRefPubMed

10.

Conceição E, Bastos AP, Brandão I, Vaz AR, Ramalho S, Arrojado F, et al. Loss of control eating and weight outcomes after bariatric surgery: a study with a Portuguese sample. Eat Weight Disord. 2014;19:103–9. doi:10.1007/s40519-013-0069-0.CrossRefPubMed

11.

Meany G, Conceição E, Mitchell JE. Binge eating, binge eating disorder and loss of control eating: effects on weight outcomes after bariatric surgery. Eur Eat Disord Rev. 2014;22:87–91. doi:10.1002/erv.2273.CrossRefPubMedPubMedCentral

12.

Conceição EM, Mitchell JE, Engel SG, Machado PPP, Lancaster K, Wonderlich SA. What is ‘grazing’? Reviewing its definition, frequency, clinical characteristics, and impact on bariatric surgery outcomes, and proposing a standardized definition. Surg Obes Relat Dis. 2014;10:973–82.CrossRefPubMed

13.

Kafri N, Valfer R, Nativ O, Shiloni E, Hazzan D. Behavioral outcomes following laparoscopic sleeve gastrectomy performed after failed laparoscopic adjustable gastric banding. Obes Surg. 2013;23:346–52.CrossRefPubMed

14.

Gade H, Friborg O, Rosenvinge JH, Småstuen MC, Hjelmesæth J. The impact of a preoperative cognitive behavioural therapy (CBT) on dysfunctional eating behaviours, affective symptoms and body weight 1 year after bariatric surgery: a randomised controlled trial. Obes Surg. 2015;25(11):2112–9. doi:10.1007/s11695-015-1673-z.CrossRefPubMedPubMedCentral

15.

Ashton K, Drerup M, Windover A, Heinberg L. Brief, four-session group CBT reduces binge eating behaviors among bariatric surgery candidates. Surg Obes Relat Dis. 2009;5:257–62.CrossRefPubMed

16.

Lier HØ, Biringer E, Stubhaug B, Tangen T. The impact of preoperative counseling on postoperative treatment adherence in bariatric surgery patients: a randomized controlled trial. Patient Educ Couns. 2012;87:336–42.CrossRefPubMed

17.

Leahey TM, Crowther JH, Irwin SR. A cognitive-behavioral mindfulness group therapy intervention for the treatment of binge eating in bariatric surgery patients. Cogn Behav Pract. 2008;15:364–75. doi:10.1016/j.cbpra.2008.01.004.CrossRef

18.

Sarwer DB, Moore RH, Spitzer JC, Wadden TA, Raper SE, Williams NN. A pilot study investigating the efficacy of postoperative dietary counseling to improve outcomes after bariatric surgery. Surg Obes Relat Dis. 2012;8:561–8. doi:10.1016/j.soard.2012.02.010.CrossRefPubMed

19.

Nijamkin MP, Campa A, Sosa J, Baum M, Himburg S, Johnson P. Comprehensive nutrition and lifestyle education improves weight loss and physical activity in Hispanic Americans following gastric bypass surgery: a randomized controlled trial. J Acad Nutr Diet. 2012;112:382–90. doi:10.1016/j.jada.2011.10.023.CrossRefPubMed

20.

van Hout GCM, Verschure SKM, van Heck GL. Psychosocial predictors of success following bariatric surgery. Obes Surg. 2005;15:552–60. doi:10.1381/0960892053723484.CrossRefPubMed

21.

Stewart KE, Olbrisch ME, Bean MK. Back on track: confronting post-surgical weight gain. Bariatr Nurs Surg Patient Care. 2010;5:179–85.CrossRef

22.

Saunders R. ‘Grazing’: a high-risk behavior. Obes Surg. 2004;14:98–102. doi:10.1381/096089204772787374.CrossRefPubMed

23.

Orth WS, Madan AK, Taddeucci RJ, Coday M, Tichansky DS. Support group meeting attendance is associated with better weight loss. Obes Surg. 2008;18:391–4.CrossRefPubMed

24.

Livhits M, Mercado C, Yermilov I, Parikh JA, Dutson E, Mehran A, et al. Is social support associated with greater weight loss after bariatric surgery? A systematic review. Obes Rev. 2011;12:142–8.CrossRefPubMed

25.

Kaiser KA, Franks SF, Smith AB. Positive relationship between support group attendance and one-year postoperative weight loss in gastric banding patients. Surg Obes Relat Dis. 2011;7:89–93.CrossRefPubMed

26.

Rudolph A, Hilbert A. A novel measure to assess self-discrimination in binge-eating disorder and obesity. Int J Obes. 2015;39:368–70. doi:10.1038/ijo.2014.89.CrossRef

27.

Beck N, Johannsen M, Støving RK, Mehlsen M, Zachariae R. Do postoperative psychotherapeutic interventions and support groups influence weight loss following bariatric surgery? A systematic review and meta-analysis of randomized and nonrandomized trials. Obes Surg. 2012;22:1790–7.CrossRefPubMed

28.

Tucker JA, Samo JA, Rand CSW, Woodward ER. Behavioral interventions to promote adaptive eating behavior and lifestyle changes following surgery for obesity: results of a two-year outcome evaluation. Int J Eat Disord. 1991;10:689–98. doi:10.1002/1098-108X(199111)10:6<689::AID-EAT2260100607>3.0.CO;2-6.CrossRef

29.

Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2008. Obes Surg. 2009;19:1605–11.CrossRefPubMed

30.

Arem H, Irwin M. A review of web-based weight loss intervention in adults. Obes Rev. 2011;12:e236–43.CrossRefPubMedPubMedCentral

31.

Myers TC, Swan-Kremeier L, Wonderlich S, Lancaster K, Mitchell JE. The use of alternative delivery systems and new technologies in the treatment of patients with eating disorders. Int J Eat Disord. 2004;36:123–43.CrossRefPubMed

32.

Thomas JG, Bond DS, Sarwer DB, Wing RR. Technology for behavioral assessment and intervention in bariatric surgery. Surg Obes Relat Dis. 2011;7:548–57. doi:10.1016/j.soard.2011.02.009.CrossRefPubMedPubMedCentral

33.

Griffiths F, Lindenmeyer A, Powell J, Lowe P, Thorogood M. Why are health care interventions delivered over the internet? A systematic review of the published literature. J Med Int Res. 2006;8:e10.

34.

de Zwaan M, Herpertz S, Zipfel S, Tuschen-Caffier B, Friederich H, Schmidt F, et al. INTERBED: internet-based guided self-help for overweight and obese patients with full or subsyndromal binge eating disorder. A multicenter randomized controlled trial. Trials. 2012;13:220. doi:10.1186/1745-6215-13-220.CrossRefPubMedPubMedCentral

35.

Bauer S, Moessner M, Wolf M, Haug S, Kordy H. ES[S]PRIT – an internet-based programme for the prevention and early intervention of eating disorders in college students. Br J Guid Couns. 2009;37:327–36. doi:10.1080/03069880902957049.CrossRef

36.

Gloster AT, Rhoades HM, Novy D, Klotsche J, Senior A, Kunik M, et al. Psychometric properties of the depression anxiety and stress scale-21 in older primary care patients. J Affect Disord. 2008;110:248–59. doi:10.1016/j.jad.2008.01.023.Psychometric.CrossRefPubMedPubMedCentral

37.

Tatham M, Turner H, Mountford VA, Tritt A, Dyas R, Waller G. Development, psychometric properties and preliminary clinical validation of a brief, session-by-session measure of eating disorder cognitions and behaviors: the ED-15. Int J Eat Disord. 2015;48(7):1005–15. doi:10.1002/eat.224302015.CrossRefPubMed

38.

Whiteside SP, Lynam DR, Miller JD, Reynolds SK. Validation of the UPPS impulsive behaviour scale: a four-factor model of impulsivity. Eur J Pers. 2005;19:559–74. doi:10.1002/per.556.CrossRef

39.

Fairburn CG, Cooper Z, O’Connor M. The Eating Disorder Examination (Edition 17.0). 2014. http://www.credo-oxford.com/pdfs/EDE_17.0D.pdf. Accessed 4 Sep 2015.

40.

van De Laar AW, Dollé MH, de Brauw LM, Bruin SC, Acherman YI. Validating the alterable weight loss (AWL) metric with 2-year weight loss outcome of 500 patients after gastric bypass. Obes Surg. 2014;24:1085–9. doi:10.1007/s11695-014-1203-4.CrossRefPubMed

41.

Deitel M, Gawdat K, Melissas J. Reporting weight loss 2007. Obes Surg. 2007;17:565–8.CrossRefPubMed

42.

Eurostat. Individuals – internet use. 2015. http://appsso.eurostat.ec.europa.eu/nui/show.do?dataset=isoc_ci_ifp_iu&lang=en. Accessed 23 Feb 2015.

43.

Eurostat. Individuals using the internet for seeking health information. 2015. http://ec.europa.eu/eurostat/tgm/table.do?tab=table&init=1&plugin=1&pcode=tin00130&language=en. Accessed 4 Sept 2015.

44.

Thomas JG, Bond DS. Review of innovations in digital health technology to promote weight control. Curr Diab Rep. 2014;14:485. doi:10.1007/s11892-014-0485-1.CrossRefPubMed

Title: APOLO-Bari, an internet-based program for longitudinal support of bariatric surgery patients: study protocol for a randomized controlled trial
Authors: Eva M. Conceição
Paulo P. P. Machado
Ana Rita Vaz
Ana Pinto-Bastos
Sofia Ramalho
Cátia Silva
Filipa Arrojado
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-016-1246-z

At a glance: The STEP trials

Springer Medicine

APOLO-Bari, an internet-based program for longitudinal support of bariatric surgery patients: study protocol for a randomized controlled trial

Abstract

Background

Methods/design

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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