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: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Exercise intervention; Type: EXPERIMENTAL; Interventions: Other: Exercise intervention | Arm Label: Exercise intervention and dietary advice; Type: EXPERIMENTAL; Interventions: Other: Exercise intervention, Other: Exercise intervention and dietary advice | Intervention Type: OTHER; Name: Exercise intervention; Assigned to Arm(s): Exercise intervention, Exercise intervention and dietary advice | Intervention Type: OTHER; Name: Exercise intervention and dietary advice; Assigned to Arm(s): Exercise intervention and dietary advice
B: Arm Label: weight loss surgery; Type: EXPERIMENTAL; Interventions: Procedure: laparoscopic sleeve gastrectomy | Arm Label: Lifestyle Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: weight management program | Intervention Type: PROCEDURE; Name: laparoscopic sleeve gastrectomy; Assigned to Arm(s): weight loss surgery | Intervention Type: BEHAVIORAL; Name: weight management program; Assigned to Arm(s): Lifestyle Intervention
C: Arm Label: Furosemide first, then Acetazolamide; Type: EXPERIMENTAL; Interventions: Drug: Furosemide first, then Acetazolamide | Arm Label: Acetazolamide first, then Furosemide; Type: EXPERIMENTAL; Interventions: Drug: Acetazolamide first, then Furosemide | Intervention Type: DRUG; Name: Furosemide first, then Acetazolamide; Assigned to Arm(s): Furosemide first, then Acetazolamide | Intervention Type: DRUG; Name: Acetazolamide first, then Furosemide; Assigned to Arm(s): Acetazolamide first, then Furosemide
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