scholarly journals A Website to Promote Physical Activity in People With Type 2 Diabetes Living in Remote or Rural Locations: Feasibility Pilot Randomized Controlled Trial

JMIR Diabetes ◽  
2017 ◽  
Vol 2 (2) ◽  
pp. e26 ◽  
Author(s):  
Jenni Connelly ◽  
Alison Kirk ◽  
Judith Masthoff ◽  
Sandra MacRury
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

scholarly journals Electrically assisted cycling for individuals with type 2 diabetes mellitus: protocol for a pilot randomized controlled trial

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Jessica E. Bourne ◽  
Angie Page ◽  
Sam Leary ◽  
Robert C. Andrews ◽  
Clare England ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Type 2 Diabetes Mellitus ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Electrically Assisted ◽  
Pilot Randomized Controlled Trial

Abstract Background The global incidence of type 2 diabetes mellitus (T2DM) is increasing. Given the many complications associated with T2DM, effective management of the disease is crucial. Physical activity is considered to be a key component of T2DM management. However, people with T2DM are generally less physically active than individuals without T2DM and adherence to physical activity is often poor following completion of lifestyle interventions. As such, developing interventions that foster sustainable physical activity is of high priority. Electrically assisted bicycles (e-bikes) have been highlighted as a potential strategy for promoting physical activity in this population. E-bikes provide electrical assistance to the rider only when pedalling and could overcome commonly reported barriers to regular cycling. This paper describes the protocol of the PEDAL-2 pilot randomized controlled trial, an e-cycling intervention aimed at increasing physical activity in individuals with T2DM. Methods A parallel-group two-arm randomized waitlist-controlled pilot trial will be conducted. Forty individuals with T2DM will be randomly assigned, in a 1:1 allocation ratio, to an e-cycling intervention or waitlist control. Recruitment and screening will close once 20 participants have been randomized to each study arm. The intervention will involve e-bike training with a certified cycle instructor and provision of an e-bike for 12 weeks. Data will be collected at baseline, during the intervention and immediately post-intervention using both quantitative and qualitative methods. In this trial, the primary interests are determination of effective recruitment strategies, recruitment and consent rates, adherence and retention and delivery and receipt of the intervention. The potential impact of the intervention on a range of clinical, physiological and behaviour outcomes will be assessed to examine intervention promise. Data analyses will be descriptive. Discussion This paper describes the protocol for the PEDAL-2 pilot randomized controlled trial. Results from this trial will provide information on trial feasibility and identify the promise of e-cycling as a strategy to positively impact the health and behaviour of individuals with T2DM. If appropriate, this information can be used to design and deliver a fully powered definitive trial. Trial registration ISRCTN, ISRCTN67421464. Registered 03/01/2019.

scholarly journals Remotely Monitored Gamification and Social Incentives to Improve Glycemic Control Among Adults With Uncontrolled Type 2 Diabetes (iDiabetes): Protocol for a Randomized Controlled Trial

10.2196/14180 ◽  
2019 ◽  
Vol 8 (11) ◽  
pp. e14180 ◽  
Author(s):  
Michael Fortunato ◽  
Joseph Harrison ◽  
Ai Leen Oon ◽  
Dylan Small ◽  
Victoria Hilbert ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Glycemic Control ◽  
Behavioral Economics ◽  
Hba1c Level ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Social Incentives

Background Type 2 diabetes is a significant cause of morbidity and mortality in the United States. Lifestyle modifications including increasing physical activity and losing weight have been demonstrated to improve glycemic control. However, most patients struggle to make these changes. Many stakeholders are interested in using gamification and social incentives to increase engagement in healthy behaviors. However, these approaches often do not appropriately leverage insights from behavioral economics that could be used to address predictable barriers to behavior change. Objective This study aimed to describe the protocol for the Influencing DIabetics to Adapt Behaviors related to Exercise and weighT by Enhancing Social incentives (iDiabetes) trial, which aimed to evaluate the effectiveness of gamification interventions that leverage insights from behavioral economics to enhance supportive, competitive, or collaborative social incentives to improve glycemic control, promote weight loss, and increase physical activity among overweight and obese adults with type 2 diabetes. Methods We are conducting a one-year four-arm randomized controlled trial of 361 overweight and obese patients with type 2 diabetes and a glycated hemoglobin (HbA1c) level ≥8.0. Wireless weight scales and wearable devices are provided to remotely monitor weight and physical activity and transmit data to the study team. Patients are recruited by email, following which they establish a baseline measure of weight, daily step count, HbA1c level, and low-density lipoprotein cholesterol level and then repeat these measures at 6 and 12 months. The control arm receives no other interventions. Patients randomized to one of the three intervention arms are entered into a game designed using insights from behavioral economics to enhance supportive, competitive, or collaborative social incentives. To examine predictors of strong or poor performance, participants completed validated questionnaires on a range of areas including their personality, risk preferences, and social network. Results Enrollment of 361 patients was completed in January 2019. Results are expected in 2020. Conclusions The iDiabetes trial represents a scalable model to remotely monitor the daily health behaviors of adults with type 2 diabetes. Results from this trial will help provide insights into how to improve management of patients with type 2 diabetes. Trial Registration ClinicalTrials.gov NCT02961192; https://clinicaltrials.gov/ct2/show/NCT02961192 International Registered Report Identifier (IRRID) DERR1-10.2196/14180

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