Reduced Occupational Sitting in Type 2 Diabetes Using mHealth (Mobile Health)

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT04219800
• Lead Sponsor: Umeå University

Brief Summary

Type 2 diabetes mellitus (T2DM) patients are suboptimal treated due to low uptake of physical activity. Recent research shows promising beneficial health effects from reducing sitting time by regular short bouts of light-intensity physical activity. These findings open up for a new focus in T2DM treatment but conclusive evidence is missing as studies have been short-term trials, mainly conducted in laboratory environments. Recent research suggest that reduced sitting and increased physical activity can be supported at a low cost by mHealth (mobile health) technology such as activity tracker armbands that warns of prolonged sitting and SMS text messages that reminds of activity breaks.

The overarching purpose of the project is to evaluate the effects of an intervention aimed to reduce occupational sitting in T2DM using mHealth (mobile health). It is hypothesized that the intervention will lead to (1) Activity changes - reduced sitting time and/or increased number of steps (primary outcome measures) and (2) Health effects - lower fatigue, improved health-related quality of life, reduced cardiometabolic risk, less sick leave, less medication, less musculoskeletal problems (secondary outcome measures)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-07
• Study Start: 2020-12-08
• Primary Completion: 2023-12-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-18
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• Type 2 Diabetes Melltitus
• 40-64 years
• HbA1c 48-100 mmol/mol
• BMI ≥ 25 kg/m2
• Working at least 75% of full-time in a mainly seated job.

Exclusion Criteria

• Pregnancy
• Regular vigorous intensity exercise
• Severe disease or for other reason unable to follow the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sitting time	12 months	Assessed by activPAL3 thigh-worn accelerometer

Secondary Outcome Measures

Name	Time	Method
Fatigue	12 months	MFI-20 questionnaire
Health-related quality of life	12 months	RAND-36 questionnaire
Steps	12 months	Assessed by activPAL3 thigh-worn accelerometer
Medications	12 months	Total use of medications
Cardiometabolic composite score (CCMR)	12 months	Will be determined by summing z-scores (\[value-mean\]/SD) of waist circumference (cm), mean arterial pressure (mmHg), HbA1c (mmol/mol), the inverse of HDL (mmol/L) and triglycerides (mmol/L), using sex-specific means and SDs
Sick leave	12 months	Assessed by diary
Musculoskeletal problems	12 months	NRS questionnaire

Trial Locations

Locations (5)

Björkskatans Hälsocentral; 🇸🇪 Luleå, Norrbotten, Sweden

Hallsbergs hälsocentral; 🇸🇪 Hallsberg, Sweden

Kärna Vårdcentral; 🇸🇪 Linköping, Sweden

Torsviks Vårdcentral; 🇸🇪 Stockholm, Sweden

Clinical Research Centre; 🇸🇪 Östersund, Sweden