Develop,Implement, and Evaluate of a Workplace-Based Resistance Training Intervention for Glycemic Control Among Office Workers with Type 2 Diabetes Mellitus.
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Eswaran.T.P.M
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Glycemic control measured by:
Overview
Brief Summary
This research project aims to develop, implement, and evaluate a workplace-based resistance training intervention to improve glycemic control among office workers with type 2 diabetes mellitus. The study is structured in three phases. Phase 1 involves developing a context-specific resistance training protocol through expert consensus using a Formative Research method. Phase 2 will conduct a pilot randomized controlled trial to test the effectiveness of the intervention on glycemic outcomes and related health parameters among office workers. Phase 3 will assess the feasibility and acceptability of the intervention through mixed-methods research. The intervention includes resistance exercises using resistance bands performed during work hours. This study addresses the significant burden of diabetes in sedentary office workers and aims to fill current gaps in workplace wellness programs by focusing on resistance training.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 30.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •The study includes adults aged between 30 to 55 years who are full-time employees engaging in sedentary office work for at least five hours daily and have a diagnosis of Type 2 Diabetes Mellitus with controlled glycemic levels, specifically HbA1c between 6.5% to 7.5% and fasting blood glucose between 124 to 200 mg/dL.
- •Both men and women working regular daytime hours in the office are eligible.
- •The intervention group consists of staff from the Manipal Academy of Higher Education (MAHE), whereas the control group includes personnel from other similar workplace settings.
Exclusion Criteria
- •encompass individuals with medical or orthopedic conditions restricting the ability to perform resistance exercises, pregnant or lactating women, those with uncontrolled diabetes indicated by HbA1c above 7.5%, those on unstable job status intending to leave within four months, current participation in other structured resistance training programs, allergies to materials used in exercises (e.g., latex), and those with neurological or nephrological complications such as foot ulcers limiting physical activity.
Outcomes
Primary Outcomes
Glycemic control measured by:
Time Frame: A. Baseline (pre-intervention) | B. Mid-intervention (after 2 months) | C. Post-intervention (after 4 months)
1. HbA1c percentage and mmol/mol
Time Frame: A. Baseline (pre-intervention) | B. Mid-intervention (after 2 months) | C. Post-intervention (after 4 months)
2. Fasting blood glucose (mg/dL)
Time Frame: A. Baseline (pre-intervention) | B. Mid-intervention (after 2 months) | C. Post-intervention (after 4 months)
Secondary Outcomes
- 1. Blood pressure (millimeters of mercury)(2. Heart rate variability (milliseconds))
Investigators
EswaranTPM
Manipal College of Health Professions, Manipal Academy of Higher Education