Relationship of exercise volume to improvements of quality of life with supervised exercise training in patients with type 2 diabetes in a randomised controlled trial: the Italian Diabetes and Exercise Study (IDES)

Abstract Background: Approximately 37% of the individuals with prediabetes will have diabetes in four years if they do not change their lifestyle through any intervention. Lifestyle modification intervention has shown to be effective in reducing or delaying the onset of type 2 diabetes mellitus (T2DM) among high-risk individuals. Some intervention approaches integrate human coaching into technology using phone or email to enable wider reach, known as digital therapy. It is considered as a scalable method to reach a larger population who are at risk, convenient and accessible. This study aims to determine the feasibility and efficacy of lifestyle intervention to prevent type 2 diabetes among adults who are at risk of developing diabetes, an assessor-blinded, parallel-group, randomised controlled trial using the Malaysia Diabetes Prevention Programme (MyDiPP) app.Methods: ‘MyDiPP’ is a 12-month lifestyle intervention digital therapy with multiple approaches (weight loss, dietary modification, physical activity and quality of life). Eligible adults are aged 18-65 years, overweight/obese (BMI ≥ 23 kgm2) and athigh-risk for type2diabetes (American Diabetes Association(ADA) Diabetes Risk Score ≥ 5, or HbA1c of 5.6-6.2%). Each participant will be randomly assigned to one oftwo study groups in 1:1 ratio using simple randomisation to intervention or usual care control groups. The primary outcome is the change in weight at 6 months and 12 months, while the secondary outcomes are changes in HbA1c level, physical activity level, dietary intake and quality of life. The MyDiPP programme is an assessor-blinded, parallel-group, randomised controlled trial, in which the app consists of educational lessons, group, technology-enabled discussions, tools to track nutritional intake, physical activity, body weight and blood glucose level as well as platform to communicate with the health coaches. Discussion: This study is necessary to determine to what extent the intervention programme reduces risks of diabetes risk in comparison to the usual care.Trial registration details:This trial was prospectively registered with Clinical Trial Registry (CTR) on 21st June 2019 with trial registration number NCT03997656.

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Effect of computerised training on cognition, sel Management and quality of life in elderly with type 2 Diabetes mellitus: a study protocol for a single blind Randomised controlled trial

International Journal of Pharma and Bio Sciences ◽

10.22376/ijpbs.2017.8.3.b544-548 ◽

2017 ◽

Vol 8 (3) ◽

Author(s):

SUMAM SUNNY ◽

DR. AJITH S ◽

DR.DHANESH KUMAR K.U

Keyword(s):

Quality Of Life ◽

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Randomised Controlled ◽

Single Blind

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Protocol for a randomised controlled trial to evaluate the effectiveness of the diabetes community exercise and education programme (DCEP) for long-term management of diabetes

BMJ Open ◽

10.1136/bmjopen-2018-025578 ◽

2019 ◽

Vol 9 (2) ◽

pp. e025578

Author(s):

Leigh Hale ◽

Tim Stokes ◽

Bonnie Scarth ◽

Ramakrishnan Mani ◽

Trudy Sullivan ◽

...

Keyword(s):

Quality Of Life ◽

Type 2 Diabetes ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Education Programme ◽

Secondary Outcome ◽

Randomised Controlled

IntroductionType 2 diabetes is common in Māori and Pacific peoples and in those living in areas of high socioeconomic deprivation in New Zealand (NZ). People with type 2 diabetes often have multimorbidity, which makes their diabetes management more complex. The Diabetes Community Exercise and Education Programme (DCEP) is an interprofessional, patient-centred, whānau (family)-supported package of care specifically developed to engage with Māori and Pacific people and those living in deprived areas. We have previously demonstrated the feasibility and acceptability of the DCEP. This study aims to determine the effectiveness and cost-effectiveness of the DCEP through a pragmatic randomised controlled trial (RCT).Methods and analysis220 adults (age ≥35 years) with type 2 diabetes will be recruited from general practices in the lower South Island of NZ (Dunedin and Invercargill) to participate in an RCT. Participants will be randomised to intervention (DCEP) and control (usual care) groups. The DCEP participants will have their exercise goals agreed on with a physiotherapist and nurse and will attend two 90 min exercise and education sessions per week for 12 weeks. The primary outcome measure is blood glucose control (glycated haemoglobin). Secondary outcome measures include quality of life assessed using the Audit of Diabetes-Dependent Quality of Life questionnaire. Data will be collected at four time points: baseline, end of the 12-week intervention (3 months), 6 months postintervention (9 months) and 12 months after the intervention ends (15 months). We will also conduct a cost-effectiveness analysis and a qualitative process evaluation.Ethics and disseminationThe study has been approved by the Health and Disability Ethics Committee, Ministry of Health (HDEC17/CEN/241/AM01). A key output will be the development of an evidence-based training package to facilitate implementation of the DCEP in other NZ regions.Trial registration numberACTRN 12617001624370 p; Pre-results.

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