Diabetes Mellitus, Type II Clinical Trial
Official title:
´Sit Less, Move More` at Work: Impact of a mHealth Intervention on the Glycaemic Control and Anthropometric Profile of Office Employees With Diabetes Type 2. A Randomized Controlled Trial.
The objective of the study is measuring the impact of a ´sit less, move more` mHealth intervention at work on the glycaemic control and anthropometric profile of office employees with diabetes type 2 (DT2) at short, mid and long term.
A double-blind randomized controlled trial. Seven Primary Care Centers from Spain (n=5
Catalonia, n=2 Madrid), 2 hospitals (n=1 Catalonia, n=1 Madrid) and 2 companies (occupational
health services; n=1 public, n=1 private) will participate in the study. In each center,
physicians, nurses, endocrinologists and occupational physicians will recruit patients with
DT2 who spend at least 55% of their working hours doing desk-based tasks (OSPAQ) and have a
cellphone. Following the CONSORT Statement (2010), volunteers will be randomized into a
control (CG) or intervention group (IG) by the research team using a computer program to
generate the random sequence. 184 individuals are needed in each group. Main variables:
fasting glucose levels, HbA1c, weight, height, BMI, waist circumference. Occupational sitting
time and sitting time breaks will be measured using ActivPAL devices. Other variables:
physical activity (IPAQ short), quality of life (EuroQool), presenteeism (WLQ),
triglycerides, total cholesterol (LDL and HDL), blood pressure and sociodemographic
variables.
Intervention: A mHealth program (13 wks) will progressively replace occupational sitting time
with light physical activities. Participants from the CG will receive usual care.
Multivariate analysis will assess changes over time (post intervention and at 6 months follow
up) in the dependent variables; looking at differences between groups. Intention to treat
will be applied.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03596177 -
A Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Participants With Type 2 Diabetes Mellitus
|
Phase 2 | |
Completed |
NCT01728740 -
Bioequivalence Study for Acarbose / Metformin FDC
|
Phase 1 | |
Completed |
NCT02648854 -
Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers
|
Phase 1 | |
Recruiting |
NCT02347020 -
Impact of Sleep and Meal Timing on Food Intake Regulation
|
N/A | |
Completed |
NCT00577590 -
Effects of Fatty Acid Delivery on Heart Metabolism and Function in Type 2 Diabetes (T2DM
|
N/A | |
Completed |
NCT00094796 -
Rosiglitazone to Reverse Metabolic Defects in Diabetes
|
Phase 2 | |
Completed |
NCT04830969 -
Impact of Periodontal Therapy on Patients With Diabetes
|
Phase 2 | |
Completed |
NCT03112382 -
Effect of SLC30A8 rs13266634 Genetic Polymorphism on Zinc Supplementation and Glycemic Control in Egyptian Patients With Type 2 Diabetes Mellitus
|
Phase 4 | |
Recruiting |
NCT01197092 -
The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
|
Phase 2 | |
Completed |
NCT00649909 -
Effect of Glucose Control on the Response to Aspirin in Type 2 Diabetic Patients
|
N/A | |
Terminated |
NCT00554697 -
Diabetes Mellitus Type II and Tissue Oxygenation
|
N/A | |
Not yet recruiting |
NCT05957224 -
Differences in Postprandial Glucose Changes
|
N/A | |
Active, not recruiting |
NCT02088658 -
Technology Intensified Diabetes Education Study in African Americans
|
N/A | |
Completed |
NCT00081328 -
Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)
|
Phase 3 | |
Completed |
NCT00482079 -
A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)
|
Phase 2 | |
Completed |
NCT03012074 -
Episodic to Real-Time Care in Diabetes Self-Management
|
N/A | |
Completed |
NCT02175537 -
Microclinic Social Induction Pilot Intervention for Diabetes and Obesity Management in Qatar
|
N/A | |
Completed |
NCT01651065 -
Micro-Clinic Obesity and Metabolic Risk Prevention Program
|
N/A | |
Completed |
NCT00528918 -
Comparison of Apidra to Regular Insulin in Hospitalized Patients
|
N/A | |
Completed |
NCT00086515 -
Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)
|
Phase 3 |