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Preliminary efficacy and feasibility of referral to exercise specialists, psychologists and provision of a technology-based behavior change support package to promote physical activity in school teachers 'at risk' of, or diagnosed with, type 2 diabetes: The 'SMART Health' Pilot Study Protocol.
Contemporary Clinical Trials 2019 January 11
INTRODUCTION: Type 2 diabetes mellitus (T2DM) is a global public health concern. Aerobic physical activity (PA) and resistance training (RT) play significant roles in the prevention and management of T2DM. The aim of this pilot trial is to determine the preliminary efficacy and confirm feasibility of referral to exercise physiologists, psychologists, and provision of a technology-based behavior change support package to promote aerobic PA and RT in school teachers 'at risk' of or diagnosed with T2DM.
RESEARCH DESIGN AND METHODS: The SMART (Support, Motivation and Physical Activity Research for Teachers') Health pilot study will be evaluated using a three-arm randomized controlled trial. The intervention will be guided by Social Cognitive Theory, Health Action Process Approach Model and Cognitive Behavioral Therapy strategies. The participants will be randomly allocated to one of three study groups: Group 1: wait-list control group; Group 2: 5 face-to-face visits with a psychologist and exercise specialist over 3 months; and Group 3: same as Group 2 plus technology-based behavior change support package for an additional 6 months. Assessments will be conducted at baseline, 3-, 9- (primary time-point) and 18-months post-baseline. The primary outcome will be PA measured with pedometers.
DISCUSSION: SMART Health is an innovative, multi-component intervention, that integrates referral to exercise specialists, psychologists and provision of a technology-based behavior support package to promote PA and RT in adults diagnosed with T2DM or 'at risk' of T2DM. The findings will be used to guide future PA interventions and to develop effective community-based diabetes prevention and treatment programs.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry No: ACTRN12616001309471.
RESEARCH DESIGN AND METHODS: The SMART (Support, Motivation and Physical Activity Research for Teachers') Health pilot study will be evaluated using a three-arm randomized controlled trial. The intervention will be guided by Social Cognitive Theory, Health Action Process Approach Model and Cognitive Behavioral Therapy strategies. The participants will be randomly allocated to one of three study groups: Group 1: wait-list control group; Group 2: 5 face-to-face visits with a psychologist and exercise specialist over 3 months; and Group 3: same as Group 2 plus technology-based behavior change support package for an additional 6 months. Assessments will be conducted at baseline, 3-, 9- (primary time-point) and 18-months post-baseline. The primary outcome will be PA measured with pedometers.
DISCUSSION: SMART Health is an innovative, multi-component intervention, that integrates referral to exercise specialists, psychologists and provision of a technology-based behavior support package to promote PA and RT in adults diagnosed with T2DM or 'at risk' of T2DM. The findings will be used to guide future PA interventions and to develop effective community-based diabetes prevention and treatment programs.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry No: ACTRN12616001309471.
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