En_Línea. An online treatment to change lifestyle in overweight and obesity: study protocol for a randomized controlled trial

Carmen Varela, Carmina Saldaña, Carmen Varela, Carmina Saldaña

Abstract

Background: Obesity has become a major public health problem. Innovative treatments are necessary. Internet and new technologies have been reported effective results in weight control programs, especially those with personalized feedback. This paper presents the protocol for a randomized controlled trial to test the effectiveness of an online weight control program, called en_línea, comparing with a standard group therapy and a control group.

Methods: This is a randomized controlled trial with three intervention arms: en_línea, standard group therapy and control group. To perform this study, 305 adults (18-65 years) with overweight type II (27-29.9 kg/m2) or obesity type I (30-34.9 kg/m2) will be invited to participate. Interventions will last 17 weeks with follow-ups 1, 3, 6 and 12 months after the post-treatment appointment. The primary outcome will be post-treatment weight loss and the maintenance during the follow-ups. Secondary outcomes will be adherence rates, drop outs and quality of life. Participants will be assessed before randomization and they will be sign an inform consent.

Discussion: The future challenge is to design innovative obesity treatments. Internet could be a useful tool to improve traditional weight control programs. This new intervention format is appropriate for patients who prefer not to share their intimate problems with a group, and for the new generations who feel comfortable using new technologies. Besides, Internet allows reaching a large amount of people at the same time, even if they live far away.

Trial registration: ClinicalTrials.gov NCT04127201. Retrospectively registered 15th October 2019.

Keywords: Internet; Obesity; Online therapy; Overweight; Randomized controlled trial; Weight control program.

Conflict of interest statement

The co-author Carmina Saldaña has received a research grant from the Ministry of Economy and Competitiveness of the Spanish Government with the reference number PSI2013–45292-R. A part from this, the authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Overview of research schedule and procedure
Fig. 2
Fig. 2
Overview of en_línea program content
Fig. 3
Fig. 3
Flow diagram of en_línea study

References

    1. NCD Risk Factor Collaboration. Trends in adult body-mass index in 200 countries from 1975 to 2014: a pooled analysis of 1698 population-based measurement studies with 19.2 million participants. Lancet. 2016; 10.1016/S0140-6736(16)30054-X.
    1. World Health Organization: Obesity and overweight. . Accessed 25 Mar 2019.
    1. James PT. Obesity: the worldwide epidemic. Clin Dermatol. 2004. 10.1016/j.clindermatol.2004.01.010.
    1. Rajan TM, Menon V. Psychiatric disorders and obesity: a review of association studies. J Postgrad Med. 2017. 10.4103/jpgm.JPGM_712_16.
    1. Puhl RM, Brownell KD. Confronting and coping weight stigma: an investigation of overweight and obese adults. Obesity. 2006. 10.1038/oby.2006.208.
    1. O’Brien KS, Latner JD, Puhl RM, Vartanian LR, Giles C, Griva K, Carter A. The relationship between weight stigma and eating behaviors is explained by weight bias internalization and psychological distress. Appetite. 102:70–6. 10.1016/j.appet.2016.02.032.
    1. Coons MJ, DeMott A, Buscemi J, Duncan JM, Pellegrini CA, Steglitz J, Pictor A, Spring B. Technology interventions to curb obesity: a systematic review of the current literature. Curr Cardiovasc Risk Rep. 2012;6(2):120. doi: 10.1007/s12170-012-0222-8.
    1. Beleigoli AM, Andradade AQ, Cançado AG, Paulo MN, Diniz MF, Ribeiro AL. Web-based digital health interventions for weight loss and lifestyle habit changes in overweight and obese adults: systematic review and meta-analysis. J Med Internet Res. 2019;21(1):e298. doi: 10.2196/jmir.9609.
    1. Sherrington A, Newham JJ, Bell R, Adamson A, McColl E, Araujo-Soares V. Systematic review and meta-analysis of internet-delivered interventions providing personalized feedback for weight loss in overweight and obese adults. Obes Rev. 2016. 10.1111/obr.12396.
    1. Rand K, Vallis M, Aston M, Price S, Piccinini-Vallis H, Rehman L, Kirk SF. It is not the diet; it is the mental part we need help with. A multilevel analysis of psychological, emotional, and social well-being in obesity. Int J Qual Stud Health Well-bein. 2017. 10.1080/17482631.2017.1306421.
    1. Kirk SF, Price SL, Penney TL, Rehman L, Lyons RF, Piccinini-Vallis H, Vallis TM, Curran J, Aston M. Blame, shame and lack of support: a multilevel study on obesity management. Qual Health Res. 2014. 10.1177/1049732314529667.
    1. Smolak L, Chun-Kennedy C. Sociocultural influences on the development of eating disorders and obesity. In: Choate LH, editor. Eating disorders and obesity: A counserlor’s guide to prevention and treatment. Alexandria: American Counseling Association; 2013. pp. 3–20.
    1. Vandelanotte C, Sugiyama T, Gardiner P, Owen N. Associations of leisure-time and computer use with overweight and obesity, physical activity and sedentary behaviors: cross-sectional study. J Med Internet Res. 2009. 10.2196/jmir.1084.
    1. Sutherland LA, Wildemuth B, Campbell MK, Haines PS. Unraveling the web: an evaluation of the content quality, usability, and readability of nutrition web sites. J Nutr Educ Behav. 2005. 10.1016/S1499-4046(06)60160-7.
    1. Internet World Stats: World internet users and 2019 population stats. . Accessed 28 Mar 2019.
    1. Spruijt-Metz D, Wen CK, O’Reilly G, Li M, Lee S, Emken BA, Mitra U, Annavaram M, Ragusa G, Narayanan S. Innovations in the use of interactive technology to support weight management. Curr Obes Rep. 2015. 10.1007/s13679-015-0183-6.
    1. Walthouwer MJ, Oenema A, Soetens K, Lechner L, De Vries H. Systematic development of a text-driven and a video-driven computer-tailored obesity prevention intervention. BMC Public Health. 2013. 10.1186/1471-2458-13-978.
    1. Hutchesson MJ, Rollo ME, Krukowski R, Ells L, Morgan PJ, Callister R, Plotnikoff R, Collins CE. eHealth interventions for the prevention and treatment of overweight and obesity in adults: a systematic review with meta-analysis. Obes Rev. 2015. 10.1111/obr.12268.
    1. Oosterveen E, Tzelepis F, Ashton L, Hutchesson J. A systematic review of eHealth behavioral interventions targeting smoking, nutrition, alcohol, physical activity and/or obesity for young adults. Prev Med. 2017;99:197. doi: 10.1016/j.ypmed.2017.01.009.
    1. Afshin A, Babalola D, Mclean M, Yu Z, Ma W, Chen C, Arabi M, Mozaffarian D. Information technology and lifestyle: a systematic evaluation of internet and mobile interventions for improving diet, physical activity, obesity, tobacco and alcohol use. J Am Heart Assoc. 2016. 10.1161/JAHA.115.003058.
    1. Matthews L, Pugmire J, Moore L, Kelson M, McConnachie A, McIntosh E, Morgan-Trimmer S, Murphy S, Hughes K, Coulman E, Utkina-Macaskill O, Simpson SA. Study protocol for the “HelpMeDoIt!” randomized controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity. BMJ Open. 2017. 10.1136/bmjopen-2017-017159.
    1. World Health Organization: Body mass Index. . Accessed 02 Apr 2019.
    1. Michie S, Abraham C, Whittington C, McAteer J, Gupta S. Effective techniques in healthy eating and physical activity interventions: a meta-regression. Health Psychol. 2009. 10.1038/a0016136.
    1. Karfopoulou E, Anastasiou CA, Avgeraki E, Kosmidis MH, Yannakolia M. The role of social support in weight loss maintenance: results from the MedWeight study. J Behav Med. 2016. 10.1007/s10865-016-9717-y.
    1. Brownell KD. The LEARN program for weight management. Dallas: American Health Publishing Company; 2004.
    1. Aranceta-Bartrina J, Pérez-Rodrigo C, Alberdi-Aresti G, Ramos-Carrera N, Lázaro-Masedo S. Prevalence of general obesity and abdominal obesity in the Spanish adult population (aged 25-64 year) 2014-2015: the ENPE study. Rev Esp Cardiol. 2016. 10.1016/j.rec.2016.02.009.
    1. Tsai A, Remmert J, Butryn ML, Wadden TA. Treatment of obesity in primary care. Med Clin N Am. 2017. 10.1016/j.mcna.2017.08.005.
    1. Wadden TA, Butryn ML, Hong PS, Tsai A. Behavioral treatment of obesity in patients encountered in primary care settings: a systematic review. JAMA. 2014. 10.1001/jama.2014.14173.
    1. Leblanc ES, O’Connor E, Whitlock EP, Patnode CD, Kapka T. Effectiveness of primary care-relevant treatments for obesity in adults: a systematic evidence review for the U.S. preventive services task force. Ann Intern Med. 2011. 10.7326/0003-4819-155-7-201110040-00006.
    1. Tremmel M, Gerdtham U, Nilsson P, Saha S. Econominc burden of obesity: a systematic literature review. Int J Environ Res Public Health. 2017. 10.3390/ijerph14040435.
    1. Chan A, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Bados A, Balaguer G, Saldaña C. Outcome of cognitive-behavioural therapy in training practice with anxiety disorder patients. Brit J Clin Psychol. 2007. 10.1348/014466507X209961.
    1. World Health Organization . The WHO STEPwise approach to Surveillance of noncommunicable diseases (STEPS) 2017.
    1. Suresh KP. An overview of randomization techniques: an unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011. 10.4103/0974-1208.82352.
    1. Saldaña C. Entrevista para la evaluación de comportamiento alimentario y actividad física en niños y adolescentes, version padres. Proyecto E-TONA. Barcelona: University of Barcelona; 2010.
    1. Cloninger C. The Temperament and Character Inventory-Revised. St. Louis, MO: Center for Psychobiology of Personality, Washington University; 1999.
    1. Gutierrez-Zotes JA, Bayón C, Montserrat G, Valero J, Labad A, Cloninger C, Fernández-Aranda F. Inventario de Temperamento y el Carácter-Revisado (TCI-R). Baremación y datos normativos en una muestra de población general. Actas Esp Psiquiatr. 2004;32:8–15.
    1. Henderson M, Freeman CP. Self-rating scale for bulimia: the BITE. Br J Psychol. 1987;150:18–24. doi: 10.1192/bjp.150.1.18.
    1. Vaz FJ, Peñas EM. Differential study of the complete and subclinical presentations of bulimia nervosa. Actas Esp Psiquiatr. 1999;27:359–365.
    1. Andrés A, Saldaña C, Gómez-Benito J. The transtheoretical model in weight management: validation of the processes of change questionnaire. Obes Facts. 2011. 10.1159/000335135.
    1. Allison KC, Lundgren JD, O’Reardon JP, Martino NS, Sarwer DB, Wadden TA, Crosby RD, Engel SG, Stunkard AJ. The Night Eating Questionnaire (NEQ): psychometric properties of a measure of severity of the night eating syndrome. Eat Behav. 2008. 10.1016/j.eatbeh.2007.03.007.
    1. Moizé V, Gluck ME, Torres F, Andreu A, Vidal J, Allison K. Transcultural adaptation of the Night Eating Questionnaire (NEQ) for its use in the Spanish population. Eat Behav. 2012;13(3):260. doi: 10.1016/j.eatbeh.2012.02.005.
    1. Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey: manual and interpretation guide. Boston: Nimrod Press; 1993.
    1. Alonso J, Prieto L, Antó JM. La versión española del SF-36 Health Survey (Cuestionario de salud SF-36): un instrumento para la medida de los resultados clínicos. Med Clin (Barc) 1995;104:771–776.
    1. Tobin D, Holroyd K, Reynols R, Kigal J. The hierarchical factor structure of Coping Strategies Inventory. Cognitive Ther Res. 1989. 10.1007/BF01173478.
    1. Cano F, Rodríguez L, García J. Adaptación española del Inventario de Estrategias de Afrontamiento. Actas Esp Psiquiatr. 2007;35:29–39.
    1. Van Strien T, Frijters J, Bergers G, Defares P. The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional and external eating behaviors. Eat Behav. 1986. 10.1002/1098-108X(198602)5:2<295::AID-EAT2260050209>;2-T.
    1. Cebolla A, Barrada JR, Van Strien T, Oliver E, Baños R. Validation of the Dutch Eating Behavior Questionnaire (DEBQ) in a sample of Spanish women. Appetite. 2014. 10.1016/j.appet.2013.10.014.
    1. Lovibond SH, Lovibond PF. Manual for the Depression Anxiety Stress Scales (DASS). New South Wales: Psychology Foundation Monograph; 1993.
    1. Bados A, Solanas A, Andrés R. Psychometric properties of the Spanish version of depression, anxiety and stress scales (DASS). Psicothema. 2005;17:679–83.
    1. Gogtay NJ. Principles of sample size calculation. Indian J Ophthalmol. 2010. 10.4103/0301-4738.71692.
    1. Melville KM, Casey LM, Kanavagh DJ. Dropbout from internet-based treatment for psychological disorders. Br J Clin Psychol. 2010. 10.1348/014466509X472138.
    1. G*Power: Statistical Power Analysis for Windows and Mac. . Accessed 10 Apr 2019.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel