Outcomes of Different Lifestyle Approaches in a Multicentre, Open-Label, Parallel-Group, Randomised Controlled Trial of the Effectiveness of Integrating a Pragmatic Pathway for Prescribing Liraglutide 3.0 mg in Weight Management Services (STRIVE Study)
Abstract
1. Introduction
2. Materials and Methods
- •
- The difference in absolute weight change between cohorts, in kg;
- •
- Changes to parameters relating to metabolic health: the waist circumference difference from baseline (cm) and glycaemic control (HbA1c);
- •
- Changes to core quality-of-life measures on EQ5D: self-reported anxiety/depression, the ability to carry out activities of daily living/self-care, and the ability to carry out usual activities.
- •
- Improvements in obesity-related complications: diabetes onset, HTN, chronic pain, and mobility.
3. Results
3.1. Participants’ Baseline Characteristics
3.2. Weight-Related Outcomes at Week 52
3.3. Weight-Related Outcomes at Week 104
3.4. Changes in Parameters Relating to Metabolism
3.4.1. Waist Circumference
3.4.2. Glycaemia
3.5. Changes in Parameters Relating to Quality of Life
3.5.1. Anxiety/Depression
3.5.2. Ability to Perform Self-Care/Activities of Daily Living
3.5.3. Ability to Carry out Usual Activities
3.5.4. Pain
3.5.5. Mobility
3.6. Changes in Parameters Relating to Complications of Obesity
3.6.1. Diabetes Onset
3.6.2. Cardiometabolic Risk Factors
4. Discussion
Secondary Outcomes
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Baseline Characteristic |
Total Population
(n = 132) |
UK Cohort
(n = 92) |
Dublin Cohort
(n = 40) | p-Value | |||
---|---|---|---|---|---|---|---|
Number | Percentage | Number | Percentage | Number | Percentage | ||
Sex | |||||||
Men | 53 | 40.2 | 35 | 38.0 | 18 | 45.0 | 0.454 |
Women | 79 | 59.9 | 57 | 62.0 | 22 | 55.0 | |
Missing | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | |
Ethnicity | |||||||
White | 114 | 86.4 | 74 | 80.4 | 40 | 100.0 | 0.028 |
Black | 11 | 8.3 | 11 | 12.0 | 0 | 0.0 | |
South Asian | 3 | 2.3 | 3 | 3.3 | 0 | 0.0 | |
Mixed/Other | 4 | 3.0 | 4 | 4.4 | 0 | 0.0 | |
Missing | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | |
Glycaemic Status | |||||||
Normoglycaemia | 66 | 50.0 | 41 | 44.6 | 25 | 62.5 | 0.184 |
Pre-diabetes | 20 | 15.2 | 17 | 18.5 | 3 | 7.5 | |
Diabetes remission | 3 | 2.3 | 3 | 3.3 | 0 | 0.0 | |
Diabetes | 41 | 31.1 | 29 | 31.5 | 12 | 30.0 | |
Missing | 2 | 1.5 | 2 | 2.2 | 0 | 0.0 | |
Hypertension status | |||||||
No | 41 | 31.1 | 34 | 37.0 | 7 | 17.5 | 0.032 |
Yes | 90 | 68.2 | 58 | 63.0 | 32 | 80.0 | |
Missing | 1 | 0.8 | 0 | 0.0 | 1 | 2.5 | |
Number of diabetes medications | |||||||
Does not have diabetes | 91 | 68.9 | 63 | 68.5 | 28 | 70.0 | 0.560 |
0 | 12 | 9.1 | 8 | 8.7 | 4 | 10.0 | |
1 | 22 | 16.7 | 17 | 18.5 | 5 | 12.5 | |
2 | 6 | 4.6 | 4 | 4.4 | 2 | 5.0 | |
≥3 | 1 | 0.8 | 0 | 0.0 | 1 | 2.5 | |
Number of antihypertensive medications | |||||||
Does not have hypertension | 44 | 33.3 | 33 | 35.9 | 11 | 27.5 | 0.456 |
0 | 24 | 18.2 | 18 | 19.6 | 6 | 15.0 | |
1 | 25 | 18.9 | 16 | 17.4 | 9 | 22.5 | |
2 | 22 | 16.7 | 16 | 17.4 | 6 | 15.0 | |
≥3 | 17 | 12.9 | 9 | 9.8 | 8 | 20.0 | |
EQ5D—Mobility | |||||||
1 | 39 | 29.6 | 26 | 28.3 | 13 | 32.5 | 0.211 |
2 | 37 | 28.0 | 24 | 26.1 | 13 | 32.5 | |
3 | 32 | 24.2 | 25 | 27.2 | 7 | 17.5 | |
4 | 17 | 12.9 | 14 | 15.2 | 3 | 7.5 | |
5 | 1 | 0.8 | 1 | 1.1 | 0 | 0.0 | |
Missing | 6 | 4.6 | 2 | 2.2 | 4 | 10.0 | |
EQ5D—Self-care | |||||||
1 | 89 | 67.4 | 61 | 66.3 | 28 | 70.0 | 0.073 |
2 | 18 | 13.6 | 13 | 14.1 | 5 | 12.5 | |
3 | 17 | 12.9 | 14 | 15.2 | 3 | 7.5 | |
4 | 3 | 2.3 | 3 | 3.3 | 0 | 0.0 | |
5 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | |
Missing | 5 | 3.8 | 1 | 1.1 | 4 | 10.0 | |
EQ5D—Usual activities | |||||||
1 | 49 | 37.1 | 31 | 33.7 | 18 | 45.0 | 0.008 |
2 | 40 | 30.3 | 29 | 31.5 | 11 | 27.5 | |
3 | 27 | 20.5 | 21 | 22.8 | 6 | 15.0 | |
4 | 12 | 9.1 | 11 | 12.0 | 1 | 2.5 | |
5 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | |
Missing | 4 | 3.0 | 0 | 0.0 | 4 | 10.0 | |
EQ5D—Pain/discomfort | |||||||
1 | 20 | 15.2 | 12 | 13.0 | 8 | 20.0 | 0.161 |
2 | 48 | 36.4 | 35 | 38.0 | 13 | 32.5 | |
3 | 32 | 24.2 | 21 | 22.8 | 11 | 27.5 | |
4 | 18 | 13.6 | 15 | 16.3 | 3 | 7.5 | |
5 | 8 | 6.1 | 7 | 7.6 | 1 | 2.5 | |
Missing | 6 | 4.6 | 2 | 2.2 | 4 | 10.0 | |
EQ5D—Anxiety/depression | |||||||
1 | 57 | 43.2 | 37 | 40.2 | 20 | 50.0 | 0.015 |
2 | 40 | 30.3 | 30 | 32.6 | 10 | 25.0 | |
3 | 23 | 17.4 | 17 | 18.5 | 6 | 15.0 | |
4 | 6 | 4.6 | 6 | 6.5 | 0 | 0.0 | |
5 | 2 | 1.5 | 2 | 2.2 | 0 | 0.0 | |
Missing | 4 | 3.0 | 0 | 0.0 | 4 | 10.0 |
Baseline Characteristic |
Total Population
(n = 132) |
UK Cohort
(n = 92) |
Dublin Cohort
(n = 40) | 1 p-Value | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
N
Missing | Mean | SD | Median | IQR |
N
Missing | Mean | SD | Median | IQR |
N
Missing | Mean | SD | Median | IQR | ||
Age, years | 0 | 51.81 | 10.77 | 53.1 | 45.5, 58.8 | 0 | 50.15 | 10.26 | 51.0 | 44.5, 56.8 | 0 | 55.63 | 11.09 | 56.9 | 48.8, 65.4 | 0.008 |
Body mass index, kg/m2 | 1 | 45.52 | 7.25 | 43.7 | 40.5, 49.4 | 0 | 46.58 | 7.54 | 45.5 | 40.9, 50.0 | 1 | 43.02 | 5.89 | 41.4 | 40.0, 47.0 | 0.004 |
Waist circumference, cm | 2 | 131.81 | 12.95 | 131.0 | 122.0, 142.3 | 0 | 132.22 | 13.36 | 131.4 | 123.2, 143.8 | 2 | 130.82 | 12.02 | 130.5 | 120.8, 140.0 | 0.480 |
HbA1c, mmol/mol | 2 | 44.71 | 10.79 | 41.0 | 38.0, 47.0 | 2 | 45.07 | 10.29 | 42.0 | 39.0, 47.0 | 0 | 43.90 | 11.93 | 40.0 | 38.0, 47.5 | 0.097 |
HbA1c, % | 2 | 6.24 | 0.99 | 5.9 | 5.6, 6.5 | 2 | 6.28 | 0.94 | 6.0 | 5.7, 6.5 | 0 | 6.16 | 1.09 | 5.8 | 5.6, 6.5 | 0.091 |
Systolic blood pressure, mmHg | 1 | 138.12 | 17.79 | 137.0 | 124.0, 152.0 | 0 | 135.85 | 18.12 | 132.5 | 124.0, 146.8 | 1 | 143.49 | 15.95 | 145.0 | 131.0, 155.0 | 0.012 |
Diastolic blood pressure, mmHg | 1 | 81.99 | 12.04 | 81.0 | 74.0, 90.0 | 0 | 80.20 | 11.39 | 79.5 | 74.0, 87.8 | 1 | 86.23 | 12.62 | 86.0 | 80.0, 96.0 | 0.004 |
Outcome Measure | UK Cohort | Dublin Cohort | p-Value | ||
---|---|---|---|---|---|
Number |
Percentage or
(Standard Deviation) | Number |
Percentage or
(Standard Deviation) | ||
Outcomes at 52 weeks | n = 66 | n = 27 | |||
>15% weight loss | 2 | 3.0% | 4 | 14.8% | 0.07 |
Waist circumference, cm | 128.7 | (11.7) | 126.9 | (12.1) | 0.09 |
HbA1c, mmol/mol | 47.1 | (11.2) | 41.9 | (10.3) | 0.03 |
New-onset diabetes | 3 | 0 | |||
Systolic blood pressure, mmHg | 136.9 | (17.1) | 140.1 | (14.9) | 0.38 |
Diastolic blood pressure, mmHg | 81.6 | (13.8) | 84.1 | (12.9) | 0.22 |
Outcomes at 104 weeks | n = 40 | n = 21 | |||
>10% weight loss | 1 | 2.5% | 3 | 14.3% | 0.04 |
Waist circumference, cm | 128.9 | (14.1) | 126.5 | (13.4) | 0.09 |
HbA1c, mmol/mol | 47.4 | (10.7) | 40.7 | (10.6) | 0.02 |
New-onset diabetes | 6 | 0 | |||
Systolic blood pressure, mmHg | 137.3 | (18.4) | 140.3 | (15.2) | 0.31 |
Diastolic blood pressure, mmHg | 82.3 | (13.1) | 83.5 | (13.7) | 0.47 |
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Al-Najim, W.; Dehestani, B.; Al-Humadi, A.W.; Bodicoat, D.H.; Papamargaritis, D.; Lean, M.; McGowan, B.; Webb, D.R.; Wilding, J.P.; Davies, M.J.; et al. Outcomes of Different Lifestyle Approaches in a Multicentre, Open-Label, Parallel-Group, Randomised Controlled Trial of the Effectiveness of Integrating a Pragmatic Pathway for Prescribing Liraglutide 3.0 mg in Weight Management Services (STRIVE Study). Metabolites 2025, 15, 398. https://doi.org/10.3390/metabo15060398
Al-Najim W, Dehestani B, Al-Humadi AW, Bodicoat DH, Papamargaritis D, Lean M, McGowan B, Webb DR, Wilding JP, Davies MJ, et al. Outcomes of Different Lifestyle Approaches in a Multicentre, Open-Label, Parallel-Group, Randomised Controlled Trial of the Effectiveness of Integrating a Pragmatic Pathway for Prescribing Liraglutide 3.0 mg in Weight Management Services (STRIVE Study). Metabolites. 2025; 15(6):398. https://doi.org/10.3390/metabo15060398
Chicago/Turabian StyleAl-Najim, Werd, Babak Dehestani, Ahmed W. Al-Humadi, Danielle H. Bodicoat, Dimitris Papamargaritis, Michael Lean, Barbara McGowan, David R. Webb, John PH Wilding, Melanie J. Davies, and et al. 2025. "Outcomes of Different Lifestyle Approaches in a Multicentre, Open-Label, Parallel-Group, Randomised Controlled Trial of the Effectiveness of Integrating a Pragmatic Pathway for Prescribing Liraglutide 3.0 mg in Weight Management Services (STRIVE Study)" Metabolites 15, no. 6: 398. https://doi.org/10.3390/metabo15060398
APA StyleAl-Najim, W., Dehestani, B., Al-Humadi, A. W., Bodicoat, D. H., Papamargaritis, D., Lean, M., McGowan, B., Webb, D. R., Wilding, J. P., Davies, M. J., & le Roux, C. W. (2025). Outcomes of Different Lifestyle Approaches in a Multicentre, Open-Label, Parallel-Group, Randomised Controlled Trial of the Effectiveness of Integrating a Pragmatic Pathway for Prescribing Liraglutide 3.0 mg in Weight Management Services (STRIVE Study). Metabolites, 15(6), 398. https://doi.org/10.3390/metabo15060398