From pills to programs: lessons from medicine for developing effective lifestyle interventions.

Abstract

To propose a scheme for comprehensive development and evaluation of lifestyle interventions. We adapted the four-phase system used in drug development, the engine of progress in medicine for decades, to construct a system for developing lifestyle intervention programs. Phase I: The intervention is constructed and tested with a small number of individuals. Acceptability and feasibility are assessed. Evaluation is primarily qualitative. Phase II: Effectiveness on intermediate endpoints (e.g. behavior) is tested in a real field setting, with a limited number of individuals, using a before-and-after design. An iterative process of testing and refinement may be necessary. Phase III: The effectiveness of the intervention on health-related outcomes is tested, using, where possible, a randomized design. Phase IV: Large-scale implementation and penetration are assessed in other populations. Process variables and local and national health indicators are studied. The development and evaluation of our hygiene intervention, which took place in Jerusalem from 1999 to 2001, is presented as a case study. Adaptation of the phased system of drug development to lifestyle interventions is a conceptually simple approach to building effective, sustainable programs for community-based public health.