Obesity in women Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
This four-arm parallel pilot study will be conducted in University College Dublin. Following an initial screening, the participants will be randomised with an allocation ratio of 1:1:1:1 into one of t
150 minutes per week
2. Resistance training: progressive resistance exercise
150 minutes per week
3. Combined training: progressive combined aerobic/resistance training
150 minutes per week
4. Control: non-exercise group (participants to maintain baseline physical activity levels)
Participants allocated to one of the exercise programmes will progress the amount and
Sponsors
University College Dublin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female aged 18-50 years at the time of consent 2. Body Mass Index (BMI) =30 kg/m² and /or a waist circumference >88 cm 3. Are currently physically inactive (exercising less than 150 min/week)
Exclusion criteria
Exclusion criteria: 1. BMI <30 kg/m² or waist circumference <88 cm 2. Unstable cardiovascular, respiratory, renal or hepatic condition 3. Contraindicated or no clinician (i.e. GP) has advised them against exercising (i.e. chest pain during activity or at rest, severe hypertension, etc) 4. Have undergone weight loss surgery in the past 3 months 5. Are pregnant (or within 6 months post-pregnancy) or lactating 6. Have a significant mental illness or cognitive deficits 7. Are participating in another trial (exercise-based or targeting weight-loss) at the time of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiorespiratory fitness is measured using VO2max at baseline and post-intervention (after 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body composition is measured using BMI, waist circumference, waist-hip ratio, fat mass, body fat percentage, and muscle mass at baseline and post-intervention (after 12 weeks) 2. Strength is measured using 5RM bench press, leg dynamometry, and grip strength at baseline and post-intervention (after 12 weeks) 3. Quality of life is measured using the EuroQol-5D-5L (EQ-5D-5L) questionnaire at baseline and post-intervention (after 12 weeks) 4. Pain is measured using the Brief Pain Inventory at baseline and post-intervention (after 12 weeks) 5. Physical activity is measured using the International Physical Activity Questionnaire (IPAQ) at baseline and post-intervention (after 12 weeks) 6. Sleep is measured using the Pittsburgh Sleep Quality Index at baseline and post-intervention (after 12 weeks) 7. Mood is measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and post-intervention (after 12 weeks) 8. Trial fidelity and feasibility are measured using the following: 8.1. Recruitment challenges 8.2. Retention rates of all trial arms 8.3. Adherence of participants (% of participants who attended >70% of sessions) 8.4. Incidence of adverse events (an adverse event defined as an event which a participant identifies a problem caused by the exercise programme that required the participant to seek treatment from a health professional and/or prevents participation in the programme) 8.5. Exercise volume/intensity adherence (reps, sets, target heart rate compliance) 8.6. The number of participants needed per group in order to achieve significance in a potential follow-up randomized controlled trial (via a power calculation) 8.7. Acceptability of trial procedures and interventions through a qualitative exploration of subjects experience of each intervention These will be measured during the study and post-intervention (after 12 weeks) as applicable | — |
Countries
Ireland
Contacts
Public ContactMary E Davis
Outcome results
None listed