Design and methodology of a community-based cluster-randomized controlled trial for dietary behaviour change in rural Kerala.

BACKGROUND
Interventions targeting lifestyle-related risk factors and non-communicable diseases have contributed to the mainstream knowledge necessary for action. However, there are gaps in how this knowledge can be translated for practical day-to-day use in complex multicultural settings like that in India. Here, we describe the design of the Behavioural Intervention for Diet study, which was developed as a community-based intervention to change dietary behaviour among middle-income households in rural Kerala.

METHODS
This was a cluster-randomized controlled trial to assess the effectiveness of a sequential stage-matched intervention to bring about dietary behaviour change by targeting the procurement and consumption of five dietary components: fruits, vegetables, salt, sugar, and oil. Following a step-wise process of pairing and exclusion of outliers, six out of 22 administrative units in the northern part of Trivandrum district, Kerala state were randomly selected and allocated to intervention or control arms. Trained community volunteers carried out the data collection and intervention delivery. An innovative tool was developed to assess household readiness-to-change, and a household measurement kit and easy formulas were introduced to facilitate the practical side of behaviour change. The 1-year intervention included a household component with sequential stage-matched intervention strategies at 0, 6, and 12 months along with counselling sessions, telephonic reminders, and home visits and a community component with general awareness sessions in the intervention arm. Households in the control arm received information on recommended levels of intake of the five dietary components and general dietary information leaflets.

CONCLUSIONS
Formative research provided the knowledge to contextualise the design of the study in accordance with socio-cultural aspects, felt needs of the community, and the ground realities associated with existing dietary procurement, preparation, and consumption patterns. The study also addressed two key issues, namely the central role of the household as the decision unit and the long-term sustainability through the use of existing local and administrative networks and community volunteers.