PROSPERO International prospective register of systematic reviews

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1 PROSPERO International prospective register of systematic reviews A systematic review of behaviour change interventions targeting physical activity, exercise and HbA1c in adults with type 2 diabetes Leah Avery, Darren Flynn, Anna van Wersch, Michael Trenell, Falko Sniehotta Citation Leah Avery, Darren Flynn, Anna van Wersch, Michael Trenell, Falko Sniehotta. A systematic review of behaviour change interventions targeting physical activity, exercise and HbA1c in adults with type 2 diabetes. PROSPERO 2011:CRD Available from Review question(s) In adults with Type 2 diabetes are behavioural interventions more effective than standard clinical care for impacting positively on free-living physical activity/exercise and glycosylated haemoglobin A1c (HbA1c)? Searches PsycINFO MEDLINE CINAHL EMBASE Scopus Cochrane Library Restrictions: English Language, Humans Types of study to be included Randomised controlled trials (RCTs). Condition or domain being studied Type 2 diabetes (HbA1c) Physical activity/exercise behaviour Participants/ population Adults aged 18 years or older, with a diagnosis of Type 2 diabetes (NIDDM or IDDM) controlled by diet, oral medication, a combination of these, or insulin. Intervention(s), exposure(s) Behavioural interventions targeting physical activity/exercise with a minimum of one month follow-up delivered by healthcare and non-healthcare professionals (including remotely via the Internet or telephone) in primary and secondary care, outpatient and community settings. The following will be excluded: (i) Interventions targeting multiple behaviors, such as PA/exercise and diet (studies were retained if all study participants received a dietary component that was consistent with usual care); Page: 1 / 5

2 (ii) targeting multiple chronic diseases or gestational diabetes; (iii) PA/exercise sessions conducted entirely in a clinical setting (e.g., exercise laboratory or hospital-based gymnasium) supervised by study personnel/clinicians, with no subsequent intervention activity out of the clinical setting (i.e., participants are not encouraged to engage in free-living PA/exercise outside of supervised sessions); (vi) included combinations of diet or pharmacological agents with PA/exercise in one arm of the trial; (v) comparisons of pharmacological agents alongside and against PA/exercise(vi) studies comparing different behavioral interventions targeting PA/exercise that did not include acomparison arm that constituted usual care. Comparator(s)/ control Studies with control/comparator arms that consist of patients with Type 2 diabetes receiving usual/standard clinical care were eligible for inclusion Context Intervention studies delivered by healthcare and non-healthcare professionals (including remotely via the Internet or telephone) in primary and secondary care, outpatient and community settings were considered for inclusion in the review. Outcome(s) Primary outcomes Studies had to include both of the following primary outcomes to be eligible for inclusion: Change in level of physical activity or exercise (measured objectively or subjectively) Change in HbA1c level Outcomes will be categorised into short, medium and long-term and were defined as follows: =4 weeks to 12 months (long-term). Secondary outcomes In addition, for studies that met the primary outcome inclusion criteria, information on the following secondary outcomes were assessed where possible: * Change in weight/bmi Change in cognitive-behavioral variables (e.g., attitudes, beliefs, self efficacy) Changes in global/dimensions of health-related quality of life Outcomes were categorised into short, medium and long-term and will be defined as follows: =4 weeks to 12 months (long-term). Data extraction, (selection and coding) All studies retained after full-text selection underwent data extraction by four members of the review team (LA, DF, FFS, AvW). In order to reduce the potential for bias, each study included in the review was independently extracted by two members of the review team, and disagreements were resolved via discussion. Any missing data were sought by contacting the corresponding authors of included studies. Salient details of the study population, intervention (including the setting, mode of delivery, types of interventionist, and type of physical activity/exercise), comparator intervention(s) and outcomes were captured using a structured data extraction form. A coding scheme developed by Michie and Prestwich (2010) was applied where possible to each included study to establish the extent to which interventions were theory-based. Descriptions of intervention content were coded into Page: 2 / 5

3 specific theory-linked behaviour change techniques using a revision to the taxonomy proposed by Abraham and Michie (2008) for interventions targeting physical activity (Michie et al 2011). Inter-rater reliability for these checklists was established using Cohen s kappa and intra-class correlation. Data were also extracted on treatment fidelity measures employed by included studies using guidance published by Bellg et al. (2004): Design of study (e.g., intensity of interventions and addressing drop out of interventionists) Monitoring and improving training (i.e., standardizing training, measuring skill acquisition and preventing skill drift) Delivery of interventions (i.e., standardizing delivery and checking for protocol adherence) Receipt of intervention (i.e., an interventionist s satisfaction with training programmes and monitoring and improving the ability of participants to understand and perform behavioral skills and cognitive strategies during delivery of the interventions) Enactment of intervention-related knowledge and skills ( the extent to which a [person] actually implements a specific behavioral skill, cognitive strategy, or motivational state at the appropriate time and setting in his or her daily life ) Risk of bias (quality) assessment All included studies underwent independent assessment of methodological quality by two members of the review team (disagreements were resolved via team discussion). The methodological quality assessment framework for RCTs developed by the Cochrane Collaboration (Higgins and Green 2009) was used to assess the risk of bias with regards to: sequence generation; allocation concealment; blinding (participants, study personnel and outcome assessors); incomplete outcome data; selective outcome reporting; and other sources of potential bias not covered by the framework. Strategy for data synthesis Data extracted from included studies were synthesized statistically using meta-analytic techniques where they were determined to be sufficiently homogeneous (assessed using the standard Chi-square test) and good methodological quality. Data synthesis will be performed according to the statistical guidelines provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins and Green 2009). Analysis of subgroups or subsets Where possible, sub-group analyses for primary outcomes (physical activity and HbA1c) different health behaviour change theories; theory-linked behaviour change techniques; and timing of outcome measurements (short-, mediumand long-term) was conducted. Dissemination plans A manuscript will be submitted to a leading journal in this field (Diabetes) and the results of the review will be disseminated locally, nationally and internationally. Contact details for further information Leah Avery MoveLab; Physical Activity & Exercise Research Group Institute of Cellular Medicine Faculty of Medical Sciences William Leech Building Newcastle University Page: 3 / 5

4 Newcastle upon Tyne NE2 4HH Organisational affiliation of the review Newcastle University Review team Miss Leah Avery, Newcastle University, NIHR Biomedical Research Centre for Ageing and MRC Centre for Brain Ageing and Vitality Dr Darren Flynn, Newcastle University, Institute of Health & Society Professor Anna van Wersch, Teesside University, School of Social Sciences & Law Dr Michael Trenell, Newcastle University, NIHR Biomedical Research Centre for Ageing and MRC Centre for Brain Ageing and Vitality Dr Falko Sniehotta, Newcastle University, Institute of Health & Society Anticipated or actual start date 01 September 2010 Anticipated completion date 30 September 2011 Funding sources/sponsors The European Union Seventh Framework Programme (FP7/ ) under grant agreement no Health- F , for the project FLIP. Conflicts of interest None known Language English Country England Subject index terms status Subject indexing assigned by CRD Subject index terms Adult; Diabetes Mellitus, Type 2; Exercise; Health Behavior; Hemoglobin A, Glycosylated; Humans Any other information This systematic review forms part of the development of a larger pilot study. In addition it is it being undertaken as part of the first authors PhD thesis Stage of review Completed and published Date of registration in PROSPERO 02 June 2011 Page: 4 / 5

5 Powered by TCPDF ( Date of publication of this revision 26 November 2013 Details of final report/publication(s) Avery L, Flynn D, van Wersch A, Sniehotta FF, Trenell MI. Changing physical activity behavior in type 2 diabetes: a systematic review and meta-analysis of behavioral interventions. Diabetes Care 2012; 35(12): DOI /CRD Stage of review at time of this submission Started Completed Preliminary searches No Yes Piloting of the study selection process No Yes Formal screening of search results against eligibility criteria No Yes Data extraction No Yes Risk of bias (quality) assessment No Yes Data analysis No Yes PROSPERO International prospective register of systematic reviews The information in this record has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Page: 5 / 5