Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Family Based Randomized Controlled Trial of Cardiovascular Risk Reduction in Individuals With Family History of Premature Coronary Heart Disease in India
Brief Summary: The overall goal of the study is to test the effectiveness and sustainability of an integrated care model for managing cardiovascular risk in individuals with family history of premature coronary heart disease (CHD).

This care model involves:

1. screening for cardiovascular risk factors,
2. providing lifestyle interventions for prevention and management of cardiovascular risk factors,
3. providing a framework for linkage to appropriate primary health care facility and
4. active follow-up of intervention adherence.

Initially, a formative qualitative research component will gather information on understanding of diseases, barriers to care, specific components of the intervention package (for example, context specific ways to enhance physical activity and to reduce prolonged sitting time, ways to improve diet etc.) and feedback on the intervention strategies (lifestyle education, care and linkage coordination). Then a randomized controlled trial involving \~700 families and 1400 participants will be used to determine whether an integrated care model is effective in reducing or halting the progression of CHD risk factors and risk factor clustering in families. The sustainability and scalability of this intervention will be assessed through economic and qualitative lenses to estimate value and acceptability. Scalability will be informed by cost-effectiveness and acceptability of the integrated cardiovascular risk reduction approach.


Options:
A: Arm Label: High intensity intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle intervention | Arm Label: Low intensity intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle intervention | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Lifestyle intervention; Assigned to Arm(s): High intensity intervention group, Low intensity intervention group
B: Arm Label: Immediate Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Immediate Intervention | Arm Label: Wait List Intervention; Type: OTHER; Interventions: Other: Wait List Intervention | Intervention Type: BEHAVIORAL; Name: Immediate Intervention; Assigned to Arm(s): Immediate Intervention | Intervention Type: OTHER; Name: Wait List Intervention; Assigned to Arm(s): Wait List Intervention
C: Arm Label: Control (Usual Care); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Simplified cardiovascular disease management | Intervention Type: OTHER; Name: Simplified cardiovascular disease management; Assigned to Arm(s): Intervention
D: Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Life style Intervention and care coordination; Type: EXPERIMENTAL; Interventions: Behavioral: Integrated cardiovascular disease risk management. | Intervention Type: BEHAVIORAL; Name: Integrated cardiovascular disease risk management.; Assigned to Arm(s): Life style Intervention and care coordination

Answer: D