Reduced Occupational Sitting in Type 2 Diabetes Using mHealth (Mobile Health) (ROSEBUD)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Patient-centered counselling and written material
mHealth
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Type 2 Diabetes Melltitus
- 40-64 years
- HbA1c 53-100 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
Sites / Locations
- Björkskatans HälsocentralRecruiting
- Hallsbergs hälsocentralRecruiting
- Kärna VårdcentralRecruiting
- Torsviks VårdcentralRecruiting
- Clinical Research CentreRecruiting
- Clinical Research CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
mHealth
Control
Arm Description
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.
Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.
Outcomes
Primary Outcome Measures
Sitting time
Assessed by activPAL3 thigh-worn accelerometer
Secondary Outcome Measures
Steps
Assessed by activPAL3 thigh-worn accelerometer
Fatigue
MFI-20 questionnaire
Health-related quality of life
RAND-36 questionnaire
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
Sick leave
Assessed by diary
Medications
Total use of medications
Musculoskeletal problems
NRS questionnaire
Full Information
NCT ID
NCT04219800
First Posted
January 2, 2020
Last Updated
December 8, 2022
Sponsor
Umeå University
Collaborators
Norrbottens County Council, Vastra Gotaland Region, Region Östergötland, Region Stockholm, Region Örebro County, Region Västerbotten, Region Jämtland Härjedalen
1. Study Identification
Unique Protocol Identification Number
NCT04219800
Brief Title
Reduced Occupational Sitting in Type 2 Diabetes Using mHealth (Mobile Health)
Acronym
ROSEBUD
Official Title
Reduced Occupational Sitting in Type 2 Diabetes Using mHealth (Mobile Health)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
Collaborators
Norrbottens County Council, Vastra Gotaland Region, Region Östergötland, Region Stockholm, Region Örebro County, Region Västerbotten, Region Jämtland Härjedalen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mHealth
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Patient-centered counselling and written material
Intervention Description
Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.
Intervention Type
Behavioral
Intervention Name(s)
mHealth
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sitting time
Description
Assessed by activPAL3 thigh-worn accelerometer
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Steps
Description
Assessed by activPAL3 thigh-worn accelerometer
Time Frame
12 months
Title
Fatigue
Description
MFI-20 questionnaire
Time Frame
12 months
Title
Health-related quality of life
Description
RAND-36 questionnaire
Time Frame
12 months
Title
Cardiometabolic composite score (CCMR)
Description
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
Time Frame
12 months
Title
Sick leave
Description
Assessed by diary
Time Frame
12 months
Title
Medications
Description
Total use of medications
Time Frame
12 months
Title
Musculoskeletal problems
Description
NRS questionnaire
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
General self-efficacy
Description
GSE-10 questionnaire
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrik Wennberg
Phone
+46907869450
Email
patrik.wennberg@umu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Brännholm Syrjälä
Email
maria.brannholm-syrjala@norrbotten.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrik Wennberg
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Björkskatans Hälsocentral
City
Luleå
State/Province
Norrbotten
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Nordendahl, PhD, MD
Email
maria.nordendahl@umu.se
First Name & Middle Initial & Last Name & Degree
Anna Bengtsson, PhD, MD
First Name & Middle Initial & Last Name & Degree
Maria Nordendahl, PhD, MD
Facility Name
Hallsbergs hälsocentral
City
Hallsberg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Jansson, PhD, MD
Email
stefan.jansson@regionorebrolan.se
First Name & Middle Initial & Last Name & Degree
Stefan Jansson, PhD, MD
Facility Name
Kärna Vårdcentral
City
Linköping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Rådholm, PhD, MD
Email
karin.radholm@liu.se
First Name & Middle Initial & Last Name & Degree
Karin Rådholm, PhD, MD
Facility Name
Torsviks Vårdcentral
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Ugarph Morawski, PhD, MD
Email
anna.ugarph-morawski@sll.se
First Name & Middle Initial & Last Name & Degree
Anna Ugarph Morawski, PhD, MD
Facility Name
Clinical Research Centre
City
Umeå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Fhärm, PhD, MD
Email
eva.fharm@umu.se
First Name & Middle Initial & Last Name & Degree
Eva Fhärm, PhD, MD
Facility Name
Clinical Research Centre
City
Östersund
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikael Lilja, PhD, MD
Email
mikael.lilja@regionjh.se
First Name & Middle Initial & Last Name & Degree
Mikael Lilja, PhD, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35897022
Citation
Syrjala MB, Bennet L, Dempsey PC, Fharm E, Hellgren M, Jansson S, Nilsson S, Nordendahl M, Rolandsson O, Radholm K, Ugarph-Morawski A, Wandell P, Wennberg P. Health effects of reduced occupational sedentary behaviour in type 2 diabetes using a mobile health intervention: a study protocol for a 12-month randomized controlled trial-the ROSEBUD study. Trials. 2022 Jul 27;23(1):607. doi: 10.1186/s13063-022-06528-x.
Results Reference
derived
Learn more about this trial
Reduced Occupational Sitting in Type 2 Diabetes Using mHealth (Mobile Health)
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