Reasons for participation and non-participation in a diabetes prevention trial among women with prior gestational diabetes mellitus (GDM)

BMC Medical Research Methodology

Fidelma P Dunne⁷  Susan B Connolly²  Ciaran O’Neill³  Liam G Glynn⁴  John Newell⁶  Brian E McGuire⁵  Irene Gibson¹  Angela O’Dea⁷  Jennifer J Infanti⁷ 

[1] Croí–The West of Ireland Cardiac Foundation, Croí Heart and Stroke Centre, Moyola Lane, Newcastle, Galway, Ireland;Division of Cardiology Cardiothoracic and Thoracic Surgery, Imperial College Healthcare NHS Trust, London, UK;J.E. Cairnes School of Business & Economics, Cairnes Building, National University of Ireland Galway, Galway, Ireland;Discipline of General Practice, National University of Ireland Galway, 1 Distillery Road, Galway, Ireland;School of Psychology, National University of Ireland Galway, University Road, Galway, Ireland;HRB Clinical Research Facility, National University of Ireland Galway, University Road, Galway, Ireland;School of Medicine, Clinical Science Institute, National University of Ireland Galway, Galway, Ireland

关键词: Randomised controlled trial;    Risk factor modification;    Barriers to participation in lifestyle intervention;    Prevention of type 2 diabetes;    Gestational diabetes mellitus;   

Others  :  866480
DOI  :  10.1186/1471-2288-14-13

 received in 2013-09-03, accepted in 2014-01-20,  发布年份 2014

【 摘 要 】

Background

Gestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Lifestyle intervention can prevent progression to type 2 diabetes in high risk populations. We designed a randomised controlled trial (RCT) to evaluate the effectiveness of an established lifestyle intervention compared to standard care for delaying diabetes onset in European women with recent GDM. Recruitment into the RCT was more challenging than anticipated with only 89 of 410 (22%) women agreeing to participate. This paper identifies factors that could enhance participation of the target population in future interventions.

Methods

We hypothesised that women who agreed to participate would have higher diabetes risk profiles than those who declined, and secondly that it would be possible to predict participation on the bases of those risk factors. To test our hypothesis, we identified the subset of women for whom we had comprehensive data on diabetes risks factors 3-5 years following GDM, reducing the sample to 43 participants and 73 decliners. We considered established diabetes risk factors: smoking, daily fruit and vegetable intake, participation in exercise, family history of diabetes, glucose values and BMI scores on post-partum re-screens, use of insulin during pregnancy, and age at delivery. We also analysed narrative data from 156 decliners to further understand barriers to and facilitators of participation.

Results

Two factors differentiated participants and decliners: age at delivery (with women older than 34 years being more likely to participate) and insulin use during pregnancy (with women requiring the use of insulin in pregnancy less likely to participate). Binary logistic regression confirmed that insulin use negatively affected the odds of participation. The most significant barriers to participation included the accessibility, affordability and practicality of the intervention.

Conclusions

Women with recent GDM face multiple barriers to lifestyle change. Intervention designers should consider: (i) the practicalities of participation for this population, (ii) research designs that capitalise on motivational differences between participants, (iii) alleviating concerns about long-term diabetes management. We hope this work will support future researchers in developing interventions that are more relevant, effective and successful in recruiting the desired population.

Trial registration

Current Controlled Trials ISRCTN41202110

【 授权许可】

   
2014 Infanti et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Dunne FP, Gaffney G: The birth of ATLANTIC DIP: an overview. Ir Med J 2012, 105(5 Suppl):2-4.
• [2]Lancet T: The global challenge of diabetes. Lancet 2008, 371(9626):1723.
• [3]Reece EA: The fetal and maternal consequences of gestational diabetes mellitus. J Matern Fetal Neonatal Med 2010, 23(3):199-203.
• [4]O'Sullivan EP, Avalos G, O'Reilly M, Dennedy MC, Gaffney G, Dunne FP: Atlantic DIP: the prevalence and consequences of gestational diabetes in Ireland. Ir Med J 2012, 105(5 Suppl):13-15.
• [5]Metzger B, Lowe L, Dyer A: Hyperglycemia and adverse pregnancy outcomes. New Eng J Med 2008, 358(19):1991-2002.
• [6]O'Sullivan EP, Avalos G, O'Reilly M, Dennedy MC, Gaffney G, Dunne F: Atlantic Diabetes in Pregnancy (DIP): the prevalence and outcomes of gestational diabetes mellitus using new diagnostic criteria. Diabetologia 2011, 54(7):1670-1675.
• [7]Lydon K, Dunne FP, Owens L, Avalos G, Sarma KM, O'Connor C, Nestor L, McGuire BE: Psychological stress associated with diabetes during pregnancy: a pilot study. Ir Med J 2012, 105(5 Suppl):26-28.
• [8]Vaarasmaki M, Pouta A, Elliot P, Tapanainen P, Sovio U, Ruokonen A, Hartikainen AL, McCarthy M, Jarvelin MR: Adolescent manifestations of metabolic syndrome among children born to women with gestational diabetes in a general-population birth cohort. Am J Epidemiol 2009, 169(10):1209-1215.
• [9]Aberg A, Westbom L: Association between maternal pre-existing or gestational diabetes and health problems in children. Acta Paediatr 2001, 90(7):746-750.
• [10]Bellamy L, Casas JP, Hingorani AD, Williams D: Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet 2009, 373(9677):1773-1779.
• [11]Hyer S, Shehata H: Gestational diabetes mellitus. Curr Obstetr Gynecol 2005, 15:368-374.
• [12]Ekelund U, Brage S, Griffin SJ, Wareham NJ: Objectively measured moderate- and vigorous-intensity physical activity but not sedentary time predicts insulin resistance in high-risk individuals. Diabetes Care 2009, 32(6):1081-1086.
• [13]O'Reilly MW, Avalos G, Dennedy MC, O'Sullivan EP, Dunne F: Atlantic DIP: high prevalence of abnormal glucose tolerance post partum is reduced by breast-feeding in women with prior gestational diabetes mellitus. Eur J Endocrinol 2011, 165(6):953-959.
• [14]O’Reilly M, Avalos G, O’Sullivan E, Dennedy M, Dunne F: High prevalence of metabolic syndrome postpartum associated with adverse maternal outcomes in women with gestational diabetes. Ir J Med Sci 2010, 179(Suppl 13):523.
• [15]Eriksson KF, Lindgärde F: Prevention of type 2 (non-insulin-dependent) diabetes mellitus by diet and physical exercise. The 6-year Malmö feasibility study. Diabetologia 1991, 34(12):891-898.
• [16]Moore SM, Hardie EA, Hackworth NJ, Critchley CR, Kyrios M, Buzwell SA, Crafti NA: Can the onset of type 2 diabetes be delayed by a group-based lifestyle intervention? A randomised control trial. Psychol Health 2010, 26(4):485-499.
• [17]Laatikainen T, Dunbar JA, Chapman A, Kilkkinen A, Vartiainen E, Heistaro S, Philpot B, Absetz P, Bunker S, O'Neil A: Prevention of type 2 diabetes by lifestyle intervention in an Australian primary health care setting: Greater Green Triangle (GGT) Diabetes Prevention Project. BMC public health 2007, 7(1):249. BioMed Central Full Text
• [18]Knowler W, Barrett-Connor E, Fowler S, Hamman R, Lachin J, Walker E, Nathan D: Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. New Eng J Med 2002, 346(6):393-403.
• [19]Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Aunola S, Cepaitis Z, Moltchanov V, Hakumäki M, Mannelin M, Martikkala V, Sundvall J, Uusitupa M: Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. New Eng J Med 2001, 344(18):1343-1350.
• [20]Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Xiao JZ, Cao HB, Liu PA: Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance: the Da Qing IGT and Diabetes Study. Diabetes Care 1997, 20(4):537-544.
• [21]Ackermann RT, Finch EA, Brizendine E, Zhou HH, Marrero DG: Translating the Diabetes Prevention Program into the community - The DEPLOY pilot study. Am J Prev Med 2008, 35(4):357-363.
• [22]Gillies CL, Abrams KR, Lambert PC, Cooper NJ, Sutton AJ, Hsu RT, Khunti K: Pharmacological and lifestyle interventions to prevent or delay type 2 diabetes in people with impaired glucose tolerance: systematic review and meta-analysis. BMJ 2007, 334(7588):19.
• [23]Lindström J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemiö K, Hämäläinen H, Härkönen P, Keinänen-Kiukaanniemi S, Laakso M, Louheranta A, Mannelin M, Paturi M, Sundvall J, Valle T, Uusitupa M, Tuomilehto J: Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet 2006, 368(9548):1673-1679.
• [24]Ratner RE, Christophi CA, Metzger BE, Dabelea D, Bennett PH, Pi-Sunyer X, Fowler S, Kahn SE: Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab 2008, 93(12):4774-4779.
• [25]Clark HD, van Walraven C, Code C, Karovitch A, Keely E: Did publication of a clinical practice guideline recommendation to screen for type 2 diabetes in women with gestational diabetes change practice? Diabetes Care 2003, 26(2):265-268.
• [26]Dietz PM, Vesco KK, Callaghan WM, Bachman DJ, Bruce FC, Berg CJ, England LJ, Hornbrook MC: Postpartum screening for diabetes after a gestational diabetes mellitus-affected pregnancy. Obstet Gynecol 2008, 112(4):868-874.
• [27]Ferrara A, Hedderson MM, Albright CL, Ehrlich SF, Quesenberry CP Jr, Peng T, Feng J, Ching J, Crites Y: A pregnancy and postpartum lifestyle intervention in women with gestational diabetes mellitus reduces diabetes risk factors: a feasibility randomized control trial. Diabetes Care 2011, 34(7):1519-1525.
• [28]Ostbye T, Krause KM, Lovelady CA, Morey MC, Bastian LA, Peterson BL, Swamy GK, Brouwer RJ, McBride CM: Active Mothers Postpartum: a randomized controlled weight-loss intervention trial. Am J Prev Med 2009, 37(3):173-180.
• [29]Hunt KJ, Conway DL: Who returns for postpartum glucose screening following gestational diabetes mellitus? Am J Obstet Gynecol 2008, 198(4):404-e1.
• [30]Kim C, McEwen LN, Piette JD, Goewey J, Ferrara A, Walker EA: Risk perception for diabetes among women with histories of gestational diabetes mellitus. Diabetes Care 2007, 30(9):2281-2286.
• [31]Morrison M, Lowe J, Collins C: Perceived risk of type 2 diabetes in Australian women with a recent history of gestational diabetes mellitus. Diabet Med 2010, 27(8):882-886.
• [32]Spirito A, Ruggiero L, Bond A, Rotondo L, Coustan DR: Screening measure to assess knowledge of diabetes in pregnancy. Diabetes Care 1990, 13(7):712-718.
• [33]Doran F, Davis K: Factors that influence physical activity for pregnant and postpartum women and implications for primary care. Aust J Prim Health 2011, 17(1):79-85.
• [34]Bennett WL, Ennen CS, Carrese JA, Hill-Briggs F, Levine DM, Nicholson WK, Clark JM: Barriers to and facilitators of postpartum follow-up care in women with recent gestational diabetes mellitus: a qualitative study. J Womens Health 2011, 20(2):239-245.
• [35]Sharp L, Cotton SC, Alexander L, Williams E, Gray NM, Reid JM: Reasons for participation and non-participation in a randomized controlled trial: postal questionnaire surveys of women eligible for TOMBOLA (Trial Of Management of Borderline and Other Low-Grade Abnormal smears). Clin Trials 2006, 3(5):431-442.
• [36]Dasgupta K, Da Costa D, Pillay S, De Civita M, Gougeon R, Leong A, Bacon S, Stotland S, Chetty VT, Garfield N: Strategies to optimize participation in diabetes prevention programs following gestational diabetes: a focus group study. PloS one 2013, 8(7):e67878.
• [37]Infanti JJ, Dunne FP AOD, Gillespie P, Gibson I, Glynn LG, Noctor E, Newell J, McGuire BE: An evaluation of Croi MyAction community lifestyle modification programme compared to standard care to reduce progression to diabetes/pre-diabetes in women with prior gestational diabetes mellitus (GDM): study protocol for a randomised controlled trial. Trials 2013, 14(1):121.
• [38]Wood D, Kotseva K, Jennings C, Mead A, Jones J, Holden A, Connolly S, De Bacquer D, De Backer G: EUROACTION: A European Society of Cardiology demonstration project in preventive cardiology: A cluster randomised controlled trial of a multi-disciplinary preventive cardiology programme for coronary patients, asymptomatic high risk individuals and their families. Eur Heart J 2004, 6(Supplement J):J3-J15.
• [39]Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De Bacquer D, Collier T, De Backer G, Faergeman O: Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet 2008, 371(9629):1999-2012.
• [40]Gibson I, Flaherty G, Cormican S, Jones J, Kerins C, Walsh AM, Costello C, Windle J, Connolly S, Crowley J: Translating guidelines to practice: findings from a multidisciplinary preventive cardiology programme in the west of Ireland. Eur J Preventive Cardiol 2013. Published online: http://dx.doi.org/10.1177/2047487313498831 webcite
• [41]Noctor E, Crowe C, Carmody LA, Avalos GM, Kirwan B, Infanti JJ, O'Dea A, Gillespie P, Newell J, McGuire B, O'Neill C, O'Shea PM, Dunne FP: ATLANTIC DIP: simplifying the follow-up of women with previous gestational diabetes. Eur J Endocrinol 2013, 169(5):681-687.
• [42]Katula JA, Vitolins MZ, Rosenberger EL, Blackwell CS, Morgan TM, Lawlor MS, Goff DC: One-year results of a community-based translation of the diabetes prevention program Healthy-Living Partnerships to Prevent Diabetes (HELP PD) project. Diabetes Care 2011, 34(7):1451-1457.
• [43]British Heart Foundation: The National Audit of Cardiac Rehabilitation. Edited by ASR. London: British Heart Foundation; 2012.
• [44]Chan DSK, Chau JPC, Chang AM: Acute coronary syndromes: cardiac rehabilitation programmes and quality of life. J Adv Nurs 2005, 49(6):591-599.
• [45]Daly J, Sindone AP, Thompson DR, Hancock K, Chang E, Davidson P: Barriers to participation in and adherence to cardiac rehabilitation programs: a critical literature review. Prog Cardiovasc Nurs 2002, 17(1):8-17.
• [46]Yohannes AM, Yalfani A, Doherty P, Bundy C: Predictors of drop-out from an outpatient cardiac rehabilitation programme. Clin Rehabil 2007, 21(3):222-229.
• [47]Taylor GH, Wilson SL, Sharp J: Medical, psychological, and sociodemographic factors associated with adherence to cardiac rehabilitation programs: a systematic review. J Cardiovasc Nurs 2011, 26(3):202-209.
• [48]French DP, Lewin RJP, Watson N, Thompson DR: Do illness perceptions predict attendance at cardiac rehabilitation and quality of life following myocardial infarction? J Psychosom Res 2005, 59(5):315-322.
• [49]Hayman RM, Taylor BJ, Peart NS, Galland BC, Sayers RM: Participation in research: Informed consent, motivation and influence. J Paediatr Child Health 2001, 37(1):51-54.
• [50]Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P: Attitudes towards clinical research amongst participants and nonparticipants. J Intern Med 2002, 251(2):156-168.
• [51]Rubin R, Fujimoto W, Marrero D, Brenneman T, Charleston J, Edelstein S, Fisher E, Jordan R, Knowler W, Lichterman L: The Diabetes Prevention Program: recruitment methods and results. Control Clin Trials 2002, 23(2):157-171.
• [52]Hunt LM, Arar NH: An analytical framework for contrasting patient and provider views of the process of chronic disease management. Med Anthropol Q 2001, 15(3):347-367.
• [53]Stephenson J, Imrie J: Do we really need RCTs to evaluate behavioural and social interventions? BMJ 1998, 316:61l-3.
• [54]McCarthy CR: Historical background of clinical trials involving women and minorities. Acad Med 1994, 69(9):695.
• [55]Coakley M, Fadiran EO, Parrish LJ, Griffith RA, Weiss E, Carter C: Dialogues on diversifying clinical trials: successful strategies for engaging women and minorities in clinical trials. J Womens Health 2012, 21(7):713-716.
• [56]Merkatz RB: Inclusion of women in clinical trials: a historical overview of scientific, ethical, and legal issues. J Obstet Gynecol Neonatal Nurs 1998, 27(1):78-84.
• [57]Angell M: Caring for women's health – what is the problem? New Eng J Med 1993, 329(4):271-272.
• [58]Grant JB, Mackinnon AJ, Christensen H, Walker J: Participants’ perceptions of motivation, randomisation and withdrawal in a randomised controlled trial of interventions for prevention of depression. J Med Ethics 2009, 35(12):768-773.
• [59]Brewin CR, Bradley C: Patient preferences and randomised clinical trials. BMJ 1989, 299(6694):313.
• [60]Brewin T, Thornton H, Bradley C, McPherson K, Gore S, Silverman W, Altman D: Patients' preferences and randomised trials. Lancet 1996, 347(9008):1118-1119.
• [61]Howard L, Thornicroft G: Patient preference randomised controlled trials in mental health research. Br J Psychiatry 2006, 188:303-304.
• [62]Schwarzer R, Renner B: Social-cognitive predictors of health behavior: Action self-efficacy and coping self-efficacy. Health psychol 2000, 19(5):487-495.
• [63]IADPSG: International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care 2010, 33(3):676-682.