Sitting less and moving more for improved metabolic and brain health in type 2 diabetes: ‘OPTIMISE your health’ trial protocol

Brakenridge, Christian J. and Gardiner, Paul A. ORCID: https://orcid.org/0000-0002-8072-2673 and Grigg, Ruth V. and Winkler, Elisabeth A. H. and Fjeldsoe, Brianna S. and Schaumberg, Mia A. and Owen, Neville and Eakin, Elizabeth G. and Biddle, Stuart J. H. ORCID: https://orcid.org/0000-0002-7663-6895 and Moodie, Marjory and Daly, Robin M. and Green, Daniel J. and Cohen, Neale and Gray, Len and Comans, Tracy and Buman, Matthew P and Goode, Ana D. and Nguyen, Phuong and Gao, Lan and Healy, Genevieve N. and Dunstan, David W. (2022) Sitting less and moving more for improved metabolic and brain health in type 2 diabetes: ‘OPTIMISE your health’ trial protocol. BMC Public Health, 22 (1):929. pp. 1-26.

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Abstract

Background: Clinical practice guidelines recommend that adults with type 2 diabetes (T2D) sit less and move more throughout the day. The 18-month OPTIMISE Your Health Clinical Trial was developed to support desk-based workers with T2D achieve these recommendations. The two-arm protocol consists of an intervention and control arms. The intervention arm receives 6 months health coaching, a sit-stand desktop workstation and an activity tracker, followed by 6 months of text message support, then 6 months maintenance. The control arm receives a delayed modified intervention after 12 months of usual care. This paper describes the methods of a randomised controlled trial (RCT) evaluating the effectiveness and cost-effectiveness of the intervention, compared to a delayed intervention control. Methods: This is a two-arm RCT being conducted in Melbourne, Australia. Desk-based workers (≥0.8 full-time equivalent) aged 35–65 years, ambulatory, and with T2D and managed glycaemic control (6.5–10.0% HbA1c), are randomised to the multicomponent intervention (target n = 125) or delayed-intervention control (target n = 125) conditions. All intervention participants receive 6 months of tailored health coaching assisting them to “sit less” and “move more” at work and throughout the day, supported by a sit-stand desktop workstation and an activity tracker (Fitbit). Participants receive text message-based extended care for a further 6-months (6–12 months) followed by 6-months of non-contact (12–18 months: maintenance). Delayed intervention occurs at 12–18 months for the control arm. Assessments are undertaken at baseline, 3, 6, 12, 15 and 18-months. Primary outcomes are activPAL-measured sitting time (h/16 h day), glycosylated haemoglobin (HbA1c; %, mmol/mol) and, cognitive function measures (visual learning and new memory; Paired Associates Learning Total Errors [adjusted]). Secondary, exploratory, and process outcomes will also be collected throughout the trial. Discussion: The OPTIMISE Your Health trial will provide unique insights into the benefits of an intervention aimed at sitting less and moving more in desk-bound office workers with T2D, with outcomes relevant to glycaemic control, and to cardiometabolic and brain health. Findings will contribute new insights to add to the evidence base on initiating and maintaining behaviour change with clinical populations and inform practice in diabetes management.


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Item Type: Article (Commonwealth Reporting Category C)
Refereed: Yes
Item Status: Live Archive
Faculty/School / Institute/Centre: Current – Faculty of Health, Engineering and Sciences - School of Health and Medical Sciences (1 Jan 2022 -)
Faculty/School / Institute/Centre: Current - Institute for Resilient Regions - Centre for Health Research (1 Apr 2020 -)
Date Deposited: 18 Jul 2022 03:18
Last Modified: 14 Oct 2022 02:26
Uncontrolled Keywords: Cognitive function; Glycaemic control; Sedentary behaviour; Type 2 diabetes
Fields of Research (2020): 42 HEALTH SCIENCES > 4299 Other health sciences > 429999 Other health sciences not elsewhere classified
42 HEALTH SCIENCES > 4207 Sports science and exercise > 420799 Sports science and exercise not elsewhere classified
32 BIOMEDICAL AND CLINICAL SCIENCES > 3299 Other biomedical and clinical sciences > 329999 Other biomedical and clinical sciences not elsewhere classified
Socio-Economic Objectives (2020): 20 HEALTH > 2001 Clinical health > 200199 Clinical health not elsewhere classified
Funding Details:
Identification Number or DOI: https://doi.org/10.1186/s12889-022-13123-x
URI: http://eprints.usq.edu.au/id/eprint/49654

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