Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effectiveness of PRECEDE Model for Health Education on Cardiovascular Risk Reduction in Patients With Type 2 Diabetes Mellitus
Brief Summary: BACKGROUND: Individual health education is considered to be essential in the overall care of patients with type 2 diabetes (DM2), although there is some uncertainty regarding its metabolic control benefits. There have been very few randomized studies on the effects of individual education on normal care in DM2 patients with a control group, and none of these have assessed the long-term results. Therefore, this study aims to use this design to assess the effectiveness of the PRECEDE (Predisposing, Reinforcing, Enabling, Causes in Educational Diagnosis, and Evaluation) education model in the metabolic control and the reduction of cardiovascular risk factors, in patients with type 2 diabetes.

METHODS: An open community randomized clinical trial will be carried out in 8 urban community health centers in the Northeastern Madrid (Spain). Six hundred patients with DM2 will be randomized in two groups: PRECEDE or conventional model for health promotion education. The main outcome measures is glycated hemoglobin A1C, body mass index (BMI), blood pressure, lipids and control criteria during the 2-year follow-up period.


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard Behavioral Weight Loss Program | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Behavioral: Stepped-Care Weight Loss Program | Intervention Type: BEHAVIORAL; Name: Standard Behavioral Weight Loss Program; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Stepped-Care Weight Loss Program; Assigned to Arm(s): 2
B: Arm Label: Conventional Health Promotion Education (CHPE).; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: CHPE | Arm Label: PRECEDE HPE model; Type: EXPERIMENTAL; Interventions: Behavioral: PRECEDE HPE model | Intervention Type: BEHAVIORAL; Name: PRECEDE HPE model; Assigned to Arm(s): PRECEDE HPE model | Intervention Type: BEHAVIORAL; Name: CHPE; Assigned to Arm(s): Conventional Health Promotion Education (CHPE).
C: Arm Label: Case-Management for Behavior Change; Type: EXPERIMENTAL; Interventions: Behavioral: Vivamos Activos Fair Oaks Program | Arm Label: Case-Management plus Home Visits; Type: EXPERIMENTAL; Interventions: Behavioral: Vivamos Activos Fair Oaks Program | Arm Label: Usual Primary Care; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Vivamos Activos Fair Oaks Program | Intervention Type: BEHAVIORAL; Name: Vivamos Activos Fair Oaks Program; Assigned to Arm(s): Case-Management for Behavior Change, Case-Management plus Home Visits, Usual Primary Care
D: Arm Label: A - GWL; Type: EXPERIMENTAL; Interventions: Behavioral: Group weight loss program | Arm Label: B - GWL+SWA; Type: EXPERIMENTAL; Interventions: Other: Group weight loss program plus use of the Senseware Armband | Arm Label: C - SWA Alone; Type: EXPERIMENTAL; Interventions: Device: Use of the senseware armband alone program | Arm Label: D - Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Group weight loss program; Assigned to Arm(s): A - GWL | Intervention Type: OTHER; Name: Group weight loss program plus use of the Senseware Armband; Assigned to Arm(s): B - GWL+SWA | Intervention Type: DEVICE; Name: Use of the senseware armband alone program; Assigned to Arm(s): C - SWA Alone

Answer: B