Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Lifestyle Management of CKD in Obese Diabetic Patients
Brief Summary: The purpose of this randomized clinical trial is to evaluate the efficacy of 3 different technology-supported approaches to engaging 300 individuals with diabetes and concurrent chronic kidney disease in weight loss, dietary sodium restriction, and dietary restriction of inorganic phosphates when compared to usual care. Participants will be randomized to 1 of 4 groups, Usual Care (UC), Social Cognitive Theory-based Group Counseling (SCT), Mobile self-monitoring with tailored feedback and counseling (MONITORING), or a combination of SCT plus MONITORING conditions (COMBINED). Investigators will evaluate the intervention arms primarily in terms of weight reduction, urinary sodium excretion, and serum phosphorus and, secondarily in terms of physical activity, blood pressure, fasting lipids, medication requirements, and pulse wave velocity. Measurements will occur at baseline, 6, and 12 months. The statistical modeling of the baseline, 6 mos and 12 mos outcome variables will be based on logistic generalized linear mixed models (for binary outcomes) linear mixed models (for continuous outcomes), and random effects multinomial models (for outcomes with more than 2 levels, such as changes in medication management). In separate analyses of the intervention arm only, investigators will model self-monitoring adherence and examine possible associations between self-monitoring adherence and outcomes. The mediating effect of self-efficacy on the primary outcomes will be evaluated using structural equation models.


Options:
A: Arm Label: High risk management; Type: EXPERIMENTAL; Interventions: Behavioral: High-risk patient standardized management package | Arm Label: Salt reduction; Type: EXPERIMENTAL; Interventions: Behavioral: Community based salt reduction program | Arm Label: high risk management and salt reduction; Type: EXPERIMENTAL; Interventions: Behavioral: High-risk patient standardized management package, Behavioral: Community based salt reduction program | Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: High-risk patient standardized management package; Assigned to Arm(s): High risk management, high risk management and salt reduction | Intervention Type: BEHAVIORAL; Name: Community based salt reduction program; Assigned to Arm(s): Salt reduction, high risk management and salt reduction
B: Arm Label: Study group; Type: EXPERIMENTAL; Interventions: Behavioral: Low-salt educational programme, Behavioral: Low-salt Bangladeshi educational programme | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Low-salt educational programme; Assigned to Arm(s): Study group | Intervention Type: BEHAVIORAL; Name: Low-salt Bangladeshi educational programme; Assigned to Arm(s): Study group | Intervention Type: BEHAVIORAL; Name: Low-salt Bangladeshi educational programme; Assigned to Arm(s): Study group
C: Arm Label: SCT-based behavioral intervention; Type: EXPERIMENTAL; Interventions: Behavioral: SCT-based behavioral intervention | Arm Label: Attention control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Attention Control | Intervention Type: BEHAVIORAL; Name: SCT-based behavioral intervention; Assigned to Arm(s): SCT-based behavioral intervention | Intervention Type: BEHAVIORAL; Name: Attention Control; Assigned to Arm(s): Attention control
D: Arm Label: Usual Care (UC); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Social Cognitive Theory (SCT); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Social Cognitive Theory | Arm Label: Monitoring; Type: ACTIVE_COMPARATOR; Interventions: Other: Monitoring | Arm Label: Combined; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Social Cognitive Theory, Other: Monitoring | Intervention Type: BEHAVIORAL; Name: Social Cognitive Theory; Assigned to Arm(s): Combined, Social Cognitive Theory (SCT) | Intervention Type: OTHER; Name: Monitoring; Assigned to Arm(s): Combined, Monitoring

Answer: D