Designing Interventions to Improve the Health of Women Using the ORBIT Model.

ABSTRACT

Researchers may find it difficult to transition from conducting descriptive, mechanistic, and associational studies to developing interventions based on those findings because little guidance is available. In this article, we present the Obesity-Related Behavioral Intervention Trials (ORBIT) model and describe its applicability in designing behaviorally oriented interventions for women. Adapted from drug development research on the translation of basic laboratory research to clinical practice, the ORBIT model emphasizes the pre-efficacy testing phases of intervention development. Phase I is focused on the definition and refinement of the intervention and incorporates various study designs, including experimental, observational, qualitative, and adaptive design. Phase II involves the use of single-group proof-of-concept, feasibility, and preliminary efficacy studies to show the feasibility and capacity of the intervention to produce change in an intermediate endpoint. Phase III involves the use of randomized controlled trials to test the efficacy of the intervention. We illustrate how the ORBIT model could be applied in a hypothetical intervention to increase a woman's sense of control of her life before behavioral weight loss efforts in the postpartum period.