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Effect of a long-term behavioural weight loss intervention on nephropathy in overweight or obese adults with type 2 diabetes: a secondary analysis of the Look AHEAD randomised clinical trial.

ABSTRACT: BACKGROUND:Long-term effects of behavioural weight loss interventions on diabetes complications are unknown. In a secondary analysis of the Look AHEAD (Action for Health in Diabetes) multicentre randomised clinical trial, we assessed whether an intensive lifestyle intervention (ILI) affects the development of nephropathy in people with type 2 diabetes. METHODS:Overweight or obese people aged 45-76 years with type 2 diabetes were randomly assigned (1:1) to ILI or to a diabetes support and education (DSE) group by a central web-based data management system, stratified by clinical centre and blocked with random block sizes. The ILI was designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity. The interventions were terminated early because of absence of effect on the primary outcome of cardiovascular disease events in the main Look AHEAD trial. Albuminuria and estimated glomerular filtration rate were prespecified as two of many other outcomes and were assessed from baseline until the interventions ended. They were combined post hoc to define the main outcome for this report, very-high-risk chronic kidney disease (CKD), based on the 2013 Kidney Disease Improving Global Outcomes (KDIGO) classification. Outcomes assessors and laboratory staff were masked to treatment, but participants and interventionists were not masked. Time-to-event data were analysed by intention to treat by the Kaplan-Meier method and proportional hazards models. The Look AHEAD trial is registered with ClinicalTrials.gov, NCT00017953. FINDINGS:Of the 5145 participants randomly assigned in the Look AHEAD trial (2570 to ILI and 2575 to DSE), analyses for very-high-risk CKD were done in 2423 (94%) of patients in the ILI group and 2408 (94%) of those in the DSE group. After a median of 8·0 years (IQR 7·9-9·9) of follow-up, the incidence of very-high-risk CKD was lower in the ILI group than in the DSE group, with incidence rates of 0·91 cases per 100 person-years in the DSE group and 0·63 per 100 person-years in the ILI group (difference 0·27 cases per 100 person-years, hazard ratio 0·69, 95% CI 0·55-0·87; p=0·0016). This effect was partly attributable to reductions in bodyweight, HbA1c, and systolic blood pressure. There were no safety concerns regarding kidney-related adverse events. INTERPRETATION:Weight loss should be considered as an adjunct to medical treatments to prevent or delay progression of CKD in overweight or obese people with type 2 diabetes. FUNDING:National Institute of Diabetes and Digestive and Kidney Diseases.

SUBMITTER: Look AHEAD Research Group

PROVIDER: S-EPMC4443484 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Effect of a long-term behavioural weight loss intervention on nephropathy in overweight or obese adults with type 2 diabetes: a secondary analysis of the Look AHEAD randomised clinical trial.

The lancet. Diabetes & endocrinology 20140810 10

<h4>Background</h4>Long-term effects of behavioural weight loss interventions on diabetes complications are unknown. In a secondary analysis of the Look AHEAD (Action for Health in Diabetes) multicentre randomised clinical trial, we assessed whether an intensive lifestyle intervention (ILI) affects the development of nephropathy in people with type 2 diabetes.<h4>Methods</h4>Overweight or obese people aged 45-76 years with type 2 diabetes were randomly assigned (1:1) to ILI or to a diabetes supp ...[more]

PMID: 25127483

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Project description:Aims and objectivesTo determine whether a weight management intervention (WMI) plus cardiac rehabilitation (CR) compared to CR alone improves outcomes for overweight and obese cardiac revascularisation patients.BackgroundDespite participating in cardiac rehabilitation (CR), few cardiac patients lose enough weight to achieve clinically significant cardiovascular disease risk reduction.DesignA randomised controlled design was used with measurements at baseline, 4 and 6 months, guided by the CONSORT checklist, see Supporting Information File S1. Adults who had undergone either coronary artery bypass surgery (CABS) or percutaneous coronary intervention (PCI) and participated in a rural CR programmes were recruited. Subjects were randomised to a 12-week telehealth WMI or control group. The primary outcome was weight loss. Secondary outcomes included physical activity, patient activation, perceived self-efficacy and use of weight management behaviours.ResultsA total of 43 subjects participated, with a mean age of 63 (±9.3) years. The WMI group had significantly more weight loss averaged across the 4 and 6 months of 13.8 (±2.8) pounds compared to the control group [mean = 7.8 (±2.2) pounds]. There were no significant differences in physical activity (activity counts or daily minutes in moderate or more intense activity). The WMI group had significantly higher levels of patient activation. They also had significantly higher total scores on the Diet and Exercise Self-Management survey, and subscales that included self-efficacy for specific eating habits and managing diet behaviour.ConclusionsFindings demonstrated the usefulness and feasibility of using telehealth delivery of the WMI for cardiac rehabilitation participants in rural communities to improve weight management outcomes.Relevance to practiceStudy findings underscore the opportunity to further improve weight loss of overweight and obese cardiac participants using a weight management intervention to augment CR participation.

Project description:This study compared the efficacy of two multi-component m-health interventions with a wait-list control group on body weight (primary outcome), and secondary outcomes of cardiovascular risk factors, lifestyle behaviours, and mental health. Three-arm randomised controlled trial (Enhanced: physical activity, diet, sleep, Traditional: physical activity, diet, Control) with assessments conducted at baseline, 6 and 12 months. Participants (n = 116) were overweight or obese adults aged 19-65 (M = 44.5 [SD = 10.5]). The 6-month intervention was delivered via a smartphone app providing educational materials, goal-setting, self-monitoring and feedback, and also included one face-to-face dietary consultation, a Fitbit and scales. The trial was prospectively registered and conducted between May 2017 and September 2018. Group differences on primary and secondary outcomes were examined between the Pooled Intervention groups (Pooled Intervention = Enhanced and Traditional) and Control groups, and then between Enhanced and Traditional groups. Nineteen participants (16.4%) formally withdrew from the trial. Compared with the Control group, average body weight of the Pooled Intervention group did not differ at 6 (between-group difference = -0.92, (95% CI -3.33, 1.48)) or 12 months (0.00, (95% CI -2.62, 2.62)). Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (-1037.03, (-2028.84, -45.22)), and improved insomnia symptoms at 12 months (-2.59, (-4.79, -0.39)). Compared with the Traditional group, the Enhanced group had increased waist circumferences (2.69, (0.20, 5.18)) and sedentary time at 6 months (105.66, (30.83, 180.48)), and improved bed time variability at 12 months (-1.08, (-1.86, -0.29)). No other significant differences were observed between groups. Relative to Controls, the Pooled Intervention groups did not differ on body weight but improved resistance training, and reduced energy intake and insomnia symptom severity. No additional weight loss was apparent when targeting improvements in physical activity, diet and sleep in combination compared with physical activity and diet.

Dataset Information

Effect of a long-term behavioural weight loss intervention on nephropathy in overweight or obese adults with type 2 diabetes: a secondary analysis of the Look AHEAD randomised clinical trial.

Publications

Effect of a long-term behavioural weight loss intervention on nephropathy in overweight or obese adults with type 2 diabetes: a secondary analysis of the Look AHEAD randomised clinical trial.

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