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    Manchester Intermittent versus Daily Diet App Study (MIDDAS): A pilot randomized controlled trial in patients with type 2 diabetes

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    Authors
    McDiarmid, S.
    Harvie, Michelle N
    Johnson, R.
    Vyas, A.
    Aglan, A.
    Moran, J.
    Ruane, H.
    Hulme, A.
    Sellers, K.
    Issa, B. G.
    Affiliation
    The Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    Aims: To test the feasibility and potential efficacy of remotely supported intermittent low energy diets (ILEDs) and continuous low energy diets (CLEDs) in people with type 2 diabetes (T2D) and the feasibility of a Randomized Controlled Trial (RCT) comparing the two approaches. Materials and methods: Seventy-nine adults with overweight/obesity and T2D (≤8 years duration) were randomized 1:1 to CLED (eight weeks/56 days of daily Optifast 820kcal (3430kJ) diet) or isoenergetic ILED (two days of Optifast and five days of a Mediterranean diet/week for 28 weeks). Weight maintenance/continued weight loss was undertaken for the remainder of the 52 weeks. Both groups received frequent telephone and/or the Oviva app support. Feasibility outcomes included study uptake, retention, app usage, dietary adherence, weight loss, and change in HbA1c at 52 weeks. Results: We enrolled 39 ILED and 40 CLED participants and 27 (69%) ILED and 30 CLED (75%) attended 52-week follow-up. Eighty-nine percent (70/79) started using the app and 86% (44/51) still used the app at 52 weeks. Intention-to-treat analysis at 52 weeks showed percentage weight loss was mean (CI) -5.4% (-7.6, -3.1%) for ILED and -6.0% (-7.9, -4.0%) for CLED. HbA1c<48mmol/mol was achieved in 42% of both groups. Mean (CI) changes in the T2D medication effect score (MES) were 0.0008 (-0.3, 0.3) for ILED and -0.5 (-0.8, -0.3) for CLED. Conclusion: The study demonstrates the feasibility and potential efficacy of remotely delivered ILED and CLED programs for weight loss and HbA1c reduction, and the feasibility of an RCT comparing the two approaches.
    Citation
    McDiarmid S, Harvie M, Johnson R, Vyas A, Aglan A, Moran J, et al. Manchester Intermittent versus Daily Diet App Study ( MIDDAS ): A pilot randomized controlled trial in patients with type 2 diabetes [Internet]. Diabetes, Obesity and Metabolism. Wiley; 2021.
    Journal
    Diabetes Obesity and Metabolism
    URI
    http://hdl.handle.net/10541/624798
    DOI
    10.1111/dom.14592
    PubMed ID
    34726317
    Additional Links
    https://dx.doi.org/10.1111/dom.14592
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1111/dom.14592
    Scopus Count
    Collections
    All Paterson Institute for Cancer Research

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