Abstract
BackgroundWeight loss maintenance is a challenge for people with type 2 diabetes mellitus (T2DM), which attenuates the long-term benefits of weight loss for diabetes management. Medication, specific dietary requirements and the psychosocial burden of T2DM signify that weight loss maintenance designed for obesity may not suit people with T2DM. The primary objective of this review is to comprehensively evaluate existing weight maintenance interventions for people with or at high risk of T2DM.MethodsWe registered a protocol for the systematic review and meta-analysis of randomised and non-randomised weight maintenance interventions for T2DM. Studies included will have been carried out in adults with clinical diagnosis of T2DM or pre-diabetes. All intervention types will be accepted (e.g. behavioural/lifestyle change and pharmacological). The primary outcomes will be weight control, glycaemic control and adverse effects. Secondary outcomes will include cardiovascular risk factors (e.g. total cholesterol, LDL-cholesterol, blood pressure control), psychological wellbeing (including health-related quality of life), change in glucose medication and waist circumference. Multiple electronic databases will be searched such as MEDLINE, EMBASE, Web of Science, PsychINFO and international registers (e.g. Cochrane Central Register of Controlled Trials, WHO ICTRP). OpenGrey will be searched for grey literature. Two researchers will screen all citations and abstracts. This process will also be conducted by an additional researcher using a semi-automated tool to reduce human error. Full-text articles will be further examined by the researchers to select a final set for further analysis, and a narrative synthesis of the evidence will be presented. Potential sources of heterogeneity will be assessed, and a meta-analysis will be conducted if feasible. Risk of bias will be evaluated using the Cochrane risk of bias tool and the certainty of evidence using the GRADE (grading of recommendations, assessment, development and evaluation) approach.DiscussionThis review will critically appraise existing weight maintenance interventions targeting T2DM. Findings will inform future intervention development to support people with T2DM delay weight regain and prolong successful diabetes management.Systematic review registrationPROSPERO CRD42020168032
Highlights
Weight loss maintenance is a challenge for people with type 2 diabetes mellitus (T2DM), which attenuates the long-term benefits of weight loss for diabetes management
Given the importance of weight maintenance for diabetes-related health outcomes and the economic savings for the healthcare system, development and implementation of weight maintenance interventions that are effective for people with or at high risk of T2DM is crucial
The systematic review described in this protocol aims to thoroughly evaluate the effectiveness of existing weight maintenance interventions that have targeted people with or at high risk of T2DM
Summary
The present study protocol is reported in accordance with the reporting guidance provided in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement [22] (Additional file 1). We will provide information on patient populations studied, the interventions evaluated, and any comparators used; how the studies have described and measured patient-important outcomes; and a brief summary of results in relation to weight maintenance, glucose control and adverse effects from the intervention. This will provide initial insight on study heterogeneity. Grading will be based on risk of bias of individual studies, inconsistency (based on variation in point estimates, confidence intervals overlap, p value of heterogeneity, I2 score, outcome of the subgroup analysis), indirectness (based on differences in interventions and patients, method of measurement of patient-important outcomes and comparison of interventions), imprecision Sample size, overlapping confidence intervals and judgement on the importance of observed differences) and publication bias (based on funding sources, size of studies and the comprehensiveness of data search)
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