Multi-site feasibility and fidelity of remote yoga intervention to improve management of type-2 diabetes: Design and methods of the HA1C (healthy active and in control) study

Abstract

Introduction

Diabetes is a leading cause of death in the United States placing tremendous burden on individuals and the health care system. Yoga could be an attractive option for adults with diabetes with potential benefits for glycemic control and stress reduction.

Methods

Healthy Active and In Control is a study examining multi-site fidelity and feasibility of remote yoga compared to standard exercise intervention for diabetes management. Adults (N = ∼30 per site) with type II diabetes (T2DM), are recruited from three sites and randomized to receive either a 12-week program of yoga or standard exercise. The yoga intervention is delivered remotely via zoom twice weekly. Participants in the standard exercise group engage in self-paced aerobic exercise with weekly staff check-in. Assessments are conducted at enrollment, end of treatment (week 12), and at 3- and 6-months post-intervention. The primary aim is to assess whether intervention components can be delivered with fidelity across the three sites. Feasibility and acceptability of the yoga and exercise interventions are compared. Data on biological (HbA1c), behavioral (e.g., physical activity, diabetes self-care behaviors), and psychological factors (e.g., mindfulness, diabetes distress) related to diabetes management are also explored along with factors associated with yoga and exercise adherence.

Conclusion

This study uses rigorous methodology to establish the feasibility and acceptability of remote-delivered yoga for individuals with T2DM from diverse populations and to assess whether the remote intervention can be delivered with fidelity across sites in preparation for a future multisite efficacy trial.