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Effects of a multicomponent life-style intervention on weight, glycemic control, depressive symptoms, and renal function in low-income, minority patients with type 2 diabetes: results of the community approach to lifestyle modification for diabetes randomized controlled trial
Moncrieft AE, Llabre MM, McCalla JR, Gutt M, Mendez AJ, Gellman MD, Goldberg RB, Schneiderman N
Psychosomatic Medicine 2016 Sep;78(7):851-860
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: Few interventions have combined life-style and psychosocial approaches in the context of type 2 diabetes management. The purpose of this study was to determine the effect of a multicomponent behavioral intervention on weight, glycemic control, renal function, and depressive symptoms in a sample of overweight/obese adults with type 2 diabetes and marked depressive symptoms. METHODS: A sample of 111 adults with type 2 diabetes were randomly assigned to a 1-year intervention (n = 57) or usual care (n = 54) in a parallel groups design. Primary outcomes included weight, glycosylated hemoglobin, and Beck Depression Inventory II score. Estimated glomerular filtration rate served as a secondary outcome. All measures were assessed at baseline and 6 and 12 months after randomization by assessors blind to randomization. Latent growth modeling was used to examine intervention effects on each outcome. RESULTS: The intervention resulted in decreased weight (mean (M) 0.322 kg, standard error (SE) 0.124 kg, p = 0.010) and glycosylated hemoglobin (M 0.066%, SE 0.028%, p = 0.017), and Beck Depression Inventory II scores (M 1.009, SE 0.226, p < 0.001), and improved estimated glomerular filtration rate (M 0.742 ml/min/1.73m2, SE 0.318 ml/min/1.73m2, p = 0.020) each month during the first 6 months relative to usual care. CONCLUSIONS: Multicomponent behavioral interventions targeting weight loss and depressive symptoms as well as diet and physical activity are efficacious in the management of Type 2 diabetes. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov ID NCT01739205.

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