A systematic search and qualitative review of reporting bias of lifestyle interventions in randomized controlled trials of diabetes prevention and management.

BACKGROUND:Scholars have documented presumptions regarding the relationships between diet, exercise, weight, and type 2 diabetes. However, it is unclear to what extent researchers contribute to these presumptions, and how often these relationships are thoroughly delineated within the context of randomized controlled trials (RCTs). Thus, the aim was to conduct a systematic search and qualitative, thematic analysis of RCTs focusing on lifestyle interventions for diabetes prevention or management, to examine how researchers discuss body weight in 1) the rationale and design of their RCTs; and 2) their presentation and interpretation of their findings. METHODS:We completed an electronic search for records published between 2007 and November 2016. Selection criteria included: RCTs with a follow-up period of ≥12 months; adult participants with type 2 diabetes/pre-diabetes; lifestyle interventions classified as dietary, exercise, and/or behavioural; primary outcomes of incident diabetes and complications, mortality, cardiovascular disease, and quality of life; and secondary outcomes of glycemic control and blood pressure. Nineteen articles were identified for inclusion and subject to thematic content analysis. RESULTS:Obesity and weight loss figured prominently in the rationale and outcomes of the majority of the articles, despite intentional exclusion of "weight loss" and "obesity" as search terms. There was ambiguity over whether weight loss was classified as inclusive to the intervention, an outcome, or a measure of adherence. Results revealed that authors frequently engaged in "spin reporting" by pooling data from intervention and control groups to test the relationship between weight lost and outcomes and in their presentation of results. CONCLUSIONS:Researchers need to be aware of their biases and assumptions regarding body weight in designing, analyzing, and interpreting lifestyle interventions for diabetes prevention and management.