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

Diabetes Mellitus, Type 2 Clinical Trial

— ROSEBUD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04219800
• Other study ID #: 2019-05383
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Patient-centered counselling and written material
Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.
• mHealth
Activity tracker armband (Garmin Vivofit); warns of prolonged sitting and counts daily steps. SMS text messages; reminds of activity breaks. Mobile video instruction for standing pause gymnastics.

Locations

Country	Name	City	State
Sweden	Hallsbergs hälsocentral	Hallsberg
Sweden	Kärna Vårdcentral	Linköping
Sweden	Björkskatans Hälsocentral	Luleå	Norrbotten
Sweden	Clinical Research Centre	Östersund
Sweden	Torsviks Vårdcentral	Stockholm
Sweden	Clinical Research Centre	Umeå

Sponsors (8)

Lead Sponsor	Collaborator
Umeå University	Norrbottens County Council, Region Jämtland Härjedalen, Region Örebro County, Region Östergötland, Region Stockholm, Region Västerbotten, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General self-efficacy	GSE-10 questionnaire	12 months
Primary	Sitting time	Assessed by activPAL3 thigh-worn accelerometer	12 months
Secondary	Steps	Assessed by activPAL3 thigh-worn accelerometer	12 months
Secondary	Fatigue	MFI-20 questionnaire	12 months
Secondary	Health-related quality of life	RAND-36 questionnaire	12 months
Secondary	Cardiometabolic composite score (CCMR)	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	12 months
Secondary	Sick leave	Assessed by diary	12 months
Secondary	Medications	Total use of medications	12 months
Secondary	Musculoskeletal problems	NRS questionnaire	12 months