Rationale and study protocol for the 'eCoFit' randomized controlled trial: Integrating smartphone technology, social support and the outdoor physical environment to improve health-related fitness among adults at risk of, or diagnosed with, Type 2 Diabetes

Contemp Clin Trials. 2016 Jul:49:116-25. doi: 10.1016/j.cct.2016.06.013. Epub 2016 Jun 28.

Abstract

Introduction: The prevalence and risk of Type 2 Diabetes (T2D) has dramatically increased over the past decade. Physical activity (PA) has significant benefits for the treatment and prevention of T2D. The aim of this study is to develop, implement and evaluate a community-based PA intervention to improve aerobic and muscular fitness among adults at risk of, or diagnosed with T2D.

Research design and methods: The eCoFit pilot intervention will be evaluated using a randomized controlled trial (RCT) design. The 20-week (Phases 1 and 2) multi-component intervention was guided by Social Cognitive Theory, Health Action Process Approach Model, and Cognitive Behavior Therapy strategies. Phase 1 (Weeks 1-10) includes: i) 5 group face-to-face sessions consisting of outdoor training and cognitive mentoring; and ii) the use of the eCoFit smartphone application with a description of where and how to use the outdoor environment to be more physically active. Phase 2 (Weeks 11-20) includes the use of the eCoFit smartphone application only. Assessments are to be conducted at baseline, 10-weeks (primary end-point) and 20-weeks (secondary end-point) post-baseline. Primary outcomes are cardio-respiratory fitness and muscular fitness (lower body). Secondary outcomes include physical, behavioral, mental health and quality of life, and social-cognitive outcomes.

Discussion: eCoFit is an innovative, multi-component intervention, which integrates smartphone technology, social support and the outdoor physical environment to promote aerobic and resistance training PA among adults at risk of, or diagnosed with T2D. The findings will be used to guide future interventions and to develop and implement effective community-based prevention programs.

Trial registration: Australian New Zealand Clinical Trials Registry No: ACTRN12615000990527.

Keywords: Outdoor physical environment; Physical activity; Pre-diabetes; Smartphone application (app); Social support; Type 2 Diabetes (T2D).

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Australia
  • Cardiorespiratory Fitness*
  • Cognitive Behavioral Therapy
  • Diabetes Mellitus, Type 2 / rehabilitation*
  • Environment
  • Exercise
  • Exercise Therapy*
  • Female
  • Humans
  • Male
  • Mental Health*
  • Middle Aged
  • Mobile Applications*
  • Muscle Strength
  • Overweight / rehabilitation*
  • Physical Fitness
  • Pilot Projects
  • Psychological Theory
  • Quality of Life*
  • Risk
  • Smartphone*
  • Social Support*

Associated data

  • ANZCTR/ACTRN12615000990527