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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Jun 5, 2020
Date Accepted: Dec 30, 2020

The final, peer-reviewed published version of this preprint can be found here:

Intermittent Versus Continuous Low-Energy Diet in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial

McDiarmid S, Harvie M, Johnson R, Vyas A, Aglan A, Moran J, Ruane H, Hulme A, Sellers K, Issa B

Intermittent Versus Continuous Low-Energy Diet in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial

JMIR Res Protoc 2021;10(3):e21116

DOI: 10.2196/21116

PMID: 33739297

PMCID: 8088860

Intermittent Versus Continuous Low Energy Diet in Patients with Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial

  • Sarah McDiarmid; 
  • Michelle Harvie; 
  • Rhona Johnson; 
  • Avni Vyas; 
  • Azza Aglan; 
  • Jacqui Moran; 
  • Helen Ruane; 
  • Amanda Hulme; 
  • Katharine Sellers; 
  • Basil Issa

ABSTRACT

Background:

Intensive face-to-face weight loss programs using continuous low energy diets (CLEDs) (800 kcal/day) can produce significant weight loss and remission from type 2 diabetes (T2D). Intermittent low energy diets (ILEDs) and remotely delivered programs could be a viable alternative to support patient choice and adherence.

Objective:

This paper describes the protocol of a pilot randomized controlled trial (RCT) to test the feasibility and efficacy of remotely supported CLED and isocaloric ILED programs amongst patients with overweight and obesity and T2D.

Methods:

This RCT recruited 79 participants from primary care, 2 NHS hospital trusts and a voluntary T2D research register in the United Kingdom. Participants were randomized to a remotely delivered CLED (n=40) (8 weeks of Optifast® 800 calorie formula diet followed by 4 weeks of food reintroduction) or an isocaloric ILED (n=39) (2 days of Optifast 800 calorie diet and 5 days of a portion controlled Mediterranean diet for 28 weeks). For the remainder of the 12 months the CLED group were asked to follow a portion controlled Mediterranean diet and the ILED group followed 1–2 days/week of a food-based 800 calorie diet and 5–6 days/week of a portion controlled Mediterranean diet. Participants received high-frequency multidisciplinary remote support from a dietitian, diabetes nurse, exercise specialist and psychologist via telephone and/or the Oviva smartphone application. The primary outcomes of the study were uptake, weight loss and change in HbA1c at 12 months. An outcome assessing trial retention was added retrospectively. Secondary outcomes assessed adherence and qualitative measures and adverse events.

Results:

A total of 79 overweight or obese participants aged 18–75 and diagnosed with T2D in the last 8 years were recruited to the Manchester Intermittent versus Daily diet Diabetes App Study (MIDDAS) between February 2018 and February 2019. Data analysis is currently underway and the first results are expected to be submitted for publication in 2020.

Conclusions:

The outcomes of the MIDDAS study will inform the feasibility of remotely delivered CLED and ILED programs in clinical practice and the requirement for a larger scale RCT. Clinical Trial: ISRCTN Registry. ISRCTN15394285; http://www.isrctn.com/ISRCTN15394285


 Citation

Please cite as:

McDiarmid S, Harvie M, Johnson R, Vyas A, Aglan A, Moran J, Ruane H, Hulme A, Sellers K, Issa B

Intermittent Versus Continuous Low-Energy Diet in Patients With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial

JMIR Res Protoc 2021;10(3):e21116

DOI: 10.2196/21116

PMID: 33739297

PMCID: 8088860

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