title: Feasibility study of portable technology for weight loss and HbA1c control in type 2 diabetes.
abstract: The study investigated the feasibility of conducting a future Randomised Controlled Trial (RCT) of a mobile health (mHealth) intervention for weight loss and HbA1c reduction in Type 2 Diabetes Mellitus (T2DM).
  
  
  
  The intervention was a small wearable mHealth device used over 12 weeks by overweight people with T2DM with the intent to lose weight and reduce their HbA1c level. A 4 week maintenance period using the device followed. The device records physical activity level and information about food consumption, and provides motivational feedback based on energy balance. Twenty-seven participants were randomised to receive no intervention; intervention alone; or intervention plus weekly motivational support. All participants received advice on diet and exercise at the start of the study. Weight and HbA1c levels were recorded at baseline and weeks 6, 12, and 16. Qualitative interviews were conducted with participants who received the intervention to explore their experiences of using the device and involvement in the study including the training received.
  
  
  
  Overall the device was perceived to be well-liked, acceptable, motivational and easy to use by participants. Some logistical changes were required during the feasibility study, including shortening of the study duration and relaxation of participant inclusion criteria. Descriptive statistics of weight and HbA1c data showed promising trends of weight loss and HbA1c reduction in both intervention groups, although this should be interpreted with caution.
  
  
  
  A number of methodological recommendations for a future RCT emerged from the current feasibility study. The mHealth device was acceptable and promising for helping individuals with T2DM to reduce their HbA1c and lose weight. Devices with similar features should be tested further in larger studies which follow these methodological recommendations.
authors.affiliation: School of Health and Related Research, Sheffield, Regent Court, The University of Sheffield, 30 Regent Street, Sheffield, S1 4DA, UK.
authors.forename: Claire L
authors.initials: CL
authors.lastname: Bentley
authors.affiliation: School of Health and Related Research, Sheffield, Regent Court, The University of Sheffield, 30 Regent Street, Sheffield, S1 4DA, UK.
authors.forename: Olubukola
authors.initials: O
authors.lastname: Otesile
authors.affiliation: Safer Care, Tamworth House, 185 Shirebrook Road, Sheffield, S8 9RF, UK.
authors.forename: Ruth
authors.initials: R
authors.lastname: Bacigalupo
authors.affiliation: Department of Oncology and Metabolism, The University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK.
authors.forename: Jackie
authors.initials: J
authors.lastname: Elliott
authors.affiliation: Department of Academic Rheumatology, King's College London, Denmark Hill, London, SE5 9RS, UK.
authors.forename: Hayley
authors.initials: H
authors.lastname: Noble
authors.affiliation: School of Health and Related Research, Sheffield, Regent Court, The University of Sheffield, 30 Regent Street, Sheffield, S1 4DA, UK.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Hawley
authors.affiliation: Department of Oncology and Metabolism, The University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Williams
authors.affiliation: School of Health and Related Research, Sheffield, Regent Court, The University of Sheffield, 30 Regent Street, Sheffield, S1 4DA, UK. p.cudd@sheffield.ac.uk.
authors.forename: Peter
authors.initials: P
authors.lastname: Cudd
mesh_terms: D000328:Adult; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000178:diet therapy / Q000628:therapy*; D015444:Exercise; D005240:Feasibility Studies; D030141:Feedback, Psychological; D005260:Female; D006442:Glycated Hemoglobin; D006801:Humans; D008297:Male; D008875:Middle Aged; D063731:Mobile Applications; D009042:Motivation; D009765:Obesity / Q000178:diet therapy / Q000628:therapy*; D017060:Patient Satisfaction; D017216:Telemedicine / Q000295:instrumentation / Q000379:methods*; D015431:Weight Loss
chemical_list: D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
keywords: Feasibility; HbA1c; Mobile health; Obesity; Type 2 diabetes; Weight