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Randomized Controlled Trial
. 2016 Sep;78(7):851-60.
doi: 10.1097/PSY.0000000000000348.

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

Ashley E Moncrieft  1 , Maria M Llabre, Judith Rey McCalla, Miriam Gutt, Armando J Mendez, Marc D Gellman, Ronald B Goldberg, Neil Schneiderman
Affiliations
Randomized Controlled Trial

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

Ashley E Moncrieft et al. Psychosom Med. 2016 Sep.

Abstract

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 = .010) and glycosylated hemoglobin (M = 0.066%, SE = 0.028%, p = .017), and Beck Depression Inventory II scores (M = 1.009, SE = 0.226, p < .001), and improved estimated glomerular filtration rate (M = 0.742 ml·min·1.73 m, SE = 0.318 ml·min·1.73 m, p = .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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Conflict of interest statement

The authors have no conflicts to declare.

Figures

FIGURE 1
FIGURE 1
CONSORT flow diagram. BDI = Beck Depression Inventory; BMI = body mass index; HbA1c = glycosylated hemoglobin; CVD = cardiovascular disease; CALM-D = Community Approach to Lifestyle Modification for Diabetes.
FIGURE 2
FIGURE 2
Observed and model implied means for weight (A), glycemic control (B), depressive symptoms (C), and renal function (D) among intervention (white triangles, solid lines) and control (black squares, dashed lines) participants at each time point. Observed means were calculated using available data at each time point and should be interpreted with caution due to data missingness. Model-implied means are calculated using model-derived parameter estimates (intercepts and β coefficients). Full-information maximum likelihood was used to account for missing data in estimation of model parameters. BDI-II = Beck Depression Inventory II; eGFR = estimated glomerular filtration rate; HbA1c = glycosylated hemoglobin.
FIGURE 3
FIGURE 3
Means and standard errors for change in weight, glycemic control, depressive symptoms, and renal function for 12 months among control participants (n = 46), intervention participants completing less than seven sessions (n = 16), and intervention participants completing at least seven sessions (n = 25). BDI-II = Beck Depression Inventory II; eGFR = estimated glomerular filtration rate; HbA1c = glycosylated hemoglobin. Color image is available only in online version (www.psychosomaticmedicine.org).
See this image and copyright information in PMC

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