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

Not Applicable
Active, not recruiting
Conditions
Diabetes Mellitus, Type 2
Interventions
Behavioral: Patient-centered counselling and written material
Behavioral: mHealth
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

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
Arm && Interventions
GroupInterventionDescription
ControlPatient-centered counselling and written materialPatient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.
mHealthPatient-centered counselling and written material1. Activity tracker armband (Garmin Vivofit); warns of prolonged sitting and counts daily steps. 2. SMS text messages; reminds of activity breaks. 3. Mobile video instruction for standing pause gymnastics.
mHealthmHealth1. Activity tracker armband (Garmin Vivofit); warns of prolonged sitting and counts daily steps. 2. SMS text messages; reminds of activity breaks. 3. Mobile video instruction for standing pause gymnastics.
Primary Outcome Measures
NameTimeMethod
Sitting time12 months

Assessed by activPAL3 thigh-worn accelerometer

Secondary Outcome Measures
NameTimeMethod
Fatigue12 months

MFI-20 questionnaire

Health-related quality of life12 months

RAND-36 questionnaire

Steps12 months

Assessed by activPAL3 thigh-worn accelerometer

Medications12 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 leave12 months

Assessed by diary

Musculoskeletal problems12 months

NRS questionnaire

Trial Locations

Locations (5)

Clinical Research Centre

🇸🇪

Östersund, Sweden

Hallsbergs hälsocentral

🇸🇪

Hallsberg, Sweden

Björkskatans Hälsocentral

🇸🇪

Luleå, Norrbotten, Sweden

Kärna Vårdcentral

🇸🇪

Linköping, Sweden

Torsviks Vårdcentral

🇸🇪

Stockholm, Sweden

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