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

NCT04219800 | Unknown

• 1 other identifier: 2019-05383
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 6

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)

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Sitting time

  Assessed by activPAL3 thigh-worn accelerometer

  12 months

Secondary Outcomes (7)

• Steps

  12 months

• Fatigue

  12 months

• Health-related quality of life

  12 months

• Cardiometabolic composite score (CCMR)

  12 months

• Sick leave

  12 months

Other Outcomes (1)

• General self-efficacy

  12 months

Study Arms (2)

mHealth

EXPERIMENTAL

1. 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.

Behavioral: Patient-centered counselling and written material; Behavioral: mHealth

Control

OTHER

Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.

Behavioral: Patient-centered counselling and written material

Interventions

Patient-centered counselling and written material BEHAVIORAL

Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.

Control; mHealth

mHealth BEHAVIORAL

1. 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.

mHealth

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Umeå University: lead
• Norrbottens County Council: collaborator
• Vastra Gotaland Region: collaborator
• Region Östergötland: collaborator
• Region Stockholm: collaborator
• Region Örebro County: collaborator
• Region Västerbotten: collaborator
• Region Jämtland Härjedalen: collaborator

Study Sites (6)

Björkskatans Hälsocentral

Luleå, Norrbotten County, Sweden

Location

Hallsbergs hälsocentral

Hallsberg, Sweden

Location

Kärna Vårdcentral

Linköping, Sweden

Location

Clinical Research Centre

Östersund, Sweden

Location

Torsviks Vårdcentral

Stockholm, Sweden

Location

Clinical Research Centre

Umeå, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35897022 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Patrik Wennberg

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 7, 2020
• Study Start: December 8, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6)