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)
by
, , , , and
Werd Al-Najim
1,2
,
Babak Dehestani
1,
Ahmed W. Al-Humadi
1,
Danielle H. Bodicoat
3,
Dimitris Papamargaritis
4,5,6,
Michael Lean
7,
Barbara McGowan
8,
David R. Webb
4,5,
John PH Wilding
9,
Melanie J. Davies
4,5 and
Carel W. le Roux
1,2,*
1
Clinical Research Centre, St. Vincent’s University Hospital, Elm Park, Dublin 4, Ireland
2
Diabetes Complications Research Centre, Conway Institute, University College Dublin, Dublin 4, Ireland
3
Independent Researcher, Leicester LE1 7RH, UK
4
Diabetes Research Centre, Leicester General Hospital, College of Life Sciences, University of Leicester, Leicester LE5 4PW, UK
5
National Institute for Health and Care Research (NIHR), Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and the University of Leicester, Leicester LE5 4PW, UK
6
Department of Diabetes and Endocrinology, Kettering General Hospital, University Hospitals of Northamptonshire NHS Group, Kettering NN16 8UZ, UK
7
School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow G31 2ER, UK
8
Diabetes, Endocrinology and Obesity (DEO) Clinical Academic Partnership, King’s Health Partners, Guy’s & St Thomas’ Hospital, London SE1 7EH, UK
9
Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool L7 8TX, UK
*
Author to whom correspondence should be addressed.
Metabolites 2025, 15(6), 398; https://doi.org/10.3390/metabo15060398
Submission received: 4 April 2025
/
Revised: 26 May 2025
/
Accepted: 10 June 2025
/
Published: 13 June 2025
(This article belongs to the Special Issue Diabetes and Metabolic Diseases: From Prevention to Clinical Management)
Abstract
Background/Objectives: The STRIVE study was a multicentre, open-label, real-world clinical trial evaluating the effectiveness of a targeted prescribing pathway for liraglutide 3.0 mg as an adjunct to standard care versus standard care alone in people with obesity attending Specialist Weight Management Services (SWMS) in the UK and Ireland. This post hoc analysis focuses on the standard care arm to explore differences in outcomes between sites, particularly the potential impact of offering meal replacements as part of usual care. Methods: Participants included individuals with a BMI ≥ 35 kg/m² and at least one obesity-related complication who received standard care at five SWMS sites. All sites provided specialist nutrition and exercise counselling; however, only the Dublin site (n = 40) included meal replacements as part of routine care. Baseline characteristics and weight change data were compared between the Dublin and UK cohorts (n = 92) at 52 and 104 weeks. Statistical comparisons were made using appropriate parametric and non-parametric tests. Results: At baseline, the Dublin cohort was significantly older (p < 0.01), had a higher prevalence of hypertension (p < 0.05), and a lower reported incidence of depression/anxiety (p < 0.05) than the UK cohort. At week 52, the Dublin group achieved greater mean weight loss (−6.1%, SD ± 5.7%) compared to the UK cohort (−1.3%, SD ± 6.7%, n = 27, p < 0.01). By week 104, Dublin participants maintained a mean weight loss of −4.4% (SD ± 5.7%) while UK participants had a mean weight gain of 0.37% (SD ± 7.6%) (p < 0.05). Conclusions: The integration of meal replacements as part of usual care may have contributed to the greater and sustained weight loss observed in the Dublin cohort compared to other SWMS in the UK.
1. Introduction
Patients with a body mass index (BMI) > 35 kg/m2 and one or more obesity-related complications can be defined as having severe and complex obesity (SCO) [1]. Such complications may include pre-diabetes, type 2 diabetes (T2DM), sleep apnoea, and hypertension (HTN) [2]. The prevalence of obesity continues to increase [3], and the rates of obesity-related complications and SCO continue to rise with it [3,4]. In Ireland and the UK, tertiary management of patients living with SCO occurs within a multidisciplinary setting within specialist weight management services (SWMSs), with the purpose of considering pharmacological and surgical options [1,2]. While these treatment options have shown great success in improving health outcomes, some barriers remain in place for their regular use, including the price and availability of medications and surgery [5,6]. Another barrier to care is that not all patients will respond to medication and surgery, but this remains difficult to predict prior to starting the interventions [7]. Finally, gastrointestinal side effects with medications and surgery are normally mild to moderate, but some patients still find these difficult to tolerate [8,9].
Lifestyle interventions are an important option for improving quality of life and health gains for people with SCO. There is no universal approach to the use of lifestyle intervention for improving health gains. General guidance for intensive lifestyle intervention has been proposed by the American Heart Association, the American College of Cardiology, and the Obesity Society [10]. Within these guidelines, the three pillars of dietary modification, physical therapy, and behavioural therapy are described [10]. However, across different countries and respective cultural contexts, the feasibility of implementing these guidelines [10] may be challenging. For example, individuals receiving high-intensity intervention are to receive a minimum of 14 in-person individual or group sessions for the first 6 months [10]. Implementing these best-practice guidelines may be difficult in more resource-challenged environments. As such, adaptability to local populations and services is an important factor in optimising lifestyle intervention for people living with obesity.
The STRIVE study was an open label, real-world, randomised controlled trial (RCT) assessing the clinical effectiveness at 52 and 104 weeks of a targeted prescribing pathway for liraglutide 3.0 mg as an adjunct to standard care in specialist weight management services (SWMSs), aiming to achieve ≥15% weight loss (WL) [2]. The STRIVE study demonstrated that 21% (54 out of 260) of the participants randomised to the targeted prescribing pathway for liraglutide 3 mg achieved more than 15% WL at one year (after passing all the three stopping rules), and approximately half of those who passed all the stopping rules and stayed on liraglutide for the second year were able to maintain ≥10% WL at 104 weeks [2,11]. Improvements in cardiometabolic risk factors and in some parameters of quality of life during the study were confirmed without new safety signals.
Our study is a post hoc analysis of the standard-care arm of the STRIVE study [11]. The aim of this analysis was to examine the differences in WL and health gain achievement within SWMSs across the UK and Irish sites involved in the STRIVE study.
2. Materials and Methods
The STRIVE study [2] recruited patients from five different specialist weight management centres: Dublin, Glasgow, Leicester, Liverpool, and London. Participants meeting the inclusion criteria for the trial [2] were randomised in a 2:1 manner, with 2 participants receiving liraglutide 3.0 mg in addition to standard care for every 1 participant receiving standard care alone. Randomisation occurred by way of a validated online system (sealedenvelope.com), and was stratified according to location and a BMI ≥ or ≤45 kg/m2. Participants were informed of their randomisation outcome at the time of randomisation.
Standard-care practice was multidisciplinary, but centres were allowed to have variations in team composition depending on local service needs and funding. Typical team members included clinical specialist nurses, dieticians, specialist physicians, psychologists, and physiotherapists. A specialist physician was available at all sites. The trial participants received best-practice care within their local centre and ongoing support throughout the trial duration of 104 weeks.
All sites delivered lifestyle interventions focused on dietary modification with a reduction of 500 kcal, physical activity for 150 min/week, and behavioural support, although the format of delivery varied. WL interventions largely focused on tailored guidance on the reduction of energy intake and promotion of physical activity. The Dublin cohort uniquely received structured partial meal replacements (Herbalife®) for breakfast and lunch as part of usual care, as well as supervised or supported exercise regimens. Local practices varied across sites, given that the STRIVE study was a pragmatic real-world study [2]. Monitoring and clinical visits occurred at pre-defined intervals, as previously described [2].
This is a post hoc analysis of the standard-care arm of the STRIVE trial. The detailed statistical analysis plan for the STRIVE study has been previously described [2], and the same methodology was followed for this post hoc analysis for all sites within the standard-care arm of the STRIVE Study. We set out to compare the achievement of ≥15% WL at weeks 52 and 104 between all sites and key secondary outcomes. These outcomes were as follows:
- •
- 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.
Descriptive statistics were used to summarise baseline characteristics and outcomes at weeks 52 and 104. Between-group comparisons for continuous variables (e.g., weight, HbA1c, waist circumference) were assessed using independent-samples t-tests or Mann–Whitney U tests, depending on the data distribution. Categorical variables (e.g., proportions achieving > 5%, >10%, or >15% WL) were analysed using chi-square tests or Fisher’s exact tests, as appropriate. Within-group changes from baseline were evaluated using paired t-tests. All statistical tests were two-tailed, with significance defined as p < 0.05. No adjustments were made for confounding variables, as this was an exploratory post hoc analysis.
3. Results
There were no statistically significant differences between the WL responses of the UK sites, but the WL was greater in the Dublin cohort. Thus, the UK sites were collapsed together and compared as one cohort with the Dublin cohort.
3.1. Participants’ Baseline Characteristics
A complete data set for 132 participants in the standard-care arm was available for analysis. There were 40 participants receiving standard care in the Dublin cohort. The remaining 92 were spread across sites based in the UK. The participant distribution in the UK cohort was as follows: Glasgow (n = 9), Leicester (n = 30), Liverpool (n = 26), and London (n = 27). The ratio of males to females was similar across all sites. Table 1 summarises the categorical baseline characteristics. Greater ethnic heterogeneity was observed within the UK cohort (p < 0.05), but no difference in mean BMI was observed between Caucasian and non-Caucasian participants.
At baseline, no differences were observed with regard to the proportions of participants with diabetes and using diabetes medications. At baseline, the participants in the Dublin cohort reported more HTN (p < 0.05), fewer challenges in performing their daily activities (p < 0.01), and less anxiety and depression (p < 0.05) than the UK cohort. The patients in the Dublin cohort were also older and had lower BMIs (Table 2).
3.2. Weight-Related Outcomes at Week 52
Data were analysed from all participants with a full data set. Data from 93 participants were analysed at 52 weeks, with n = 27 from the Dublin cohort and n = 66 from the UK cohort (Table 3). At 1 year, 14.8% (4/27) of the Dublin participants and 3.0% (2/66) of the UK participants achieved >15% WL, representing a non-significant trend toward greater WL in the Dublin cohort (p = 0.07). Participants in the Dublin cohort lost more kilograms and a greater percentage of body weight at all time points. At week 52, a significantly higher proportion of participants from Dublin achieved ≥5% WL compared to the UK cohort (p < 0.05).
3.3. Weight-Related Outcomes at Week 104
Data were available for n = 61 participants at week 104, with n = 40 from the UK cohort and n = 21 from the Dublin cohort (Table 3). At this time point, participants in the Dublin cohort were significantly more likely to have lost ≥10% of their baseline body weight compared to their UK counterparts (p < 0.05). From baseline to week 104, participants in the UK cohort gained an average of 0.71 kg (SD ± 9.52), while those in the Dublin cohort lost an average of 5.7 kg (SD ± 10.88).
3.4. Changes in Parameters Relating to Metabolism
3.4.1. Waist Circumference
Data were available for n = 61 participants at week 104, with n = 40 from the UK cohort and n = 21 from the Dublin cohort (Tabel 3). At each of these time points, there was no statistically significant difference in waist circumference between the Dublin and UK cohorts (all p = 0.09).
3.4.2. Glycaemia
Data were available for n = 61 participants at week 104, with n = 40 from the UK cohort and n = 21 from the Dublin cohort (Tabel 3). At baseline, there was no difference in HbA1c between the Dublin and UK cohorts. However, at week 52, in the Dublin cohort, the HbA1c decreased from baseline, whereas in the UK cohort, it increased from baseline (p = 0.03). This difference became more pronounced at week 104, when the HbA1c increased from baseline in the UK cohort and further decreased in the Dublin cohort (p = 0.02).
3.5. Changes in Parameters Relating to Quality of Life
3.5.1. Anxiety/Depression
Data were analysed for 46 participants from the UK cohort and 15 participants from the Dublin cohort. The participants in the Dublin cohort were less likely at baseline to report anxiety/depression on the EQ5D (p = 0.015). No difference was noted between cohorts for improvement in anxiety/depression self-reporting at week 52. At week 52, 29.5% of all the participants had worsening in their anxiety/depression self-rating between baseline and week 52, which was associated with weight gain from baseline. At week 104, 14.8% of all the participants had worsening in their anxiety/depression self-rating between the visits at weeks 52 and 104, which was also associated with weight gain from baseline.
3.5.2. Ability to Perform Self-Care/Activities of Daily Living
Data were available for n = 46 from the UK cohort and n = 15 from the Dublin cohort. At baseline, there was no difference between the UK or Dublin cohorts for self-rated ability to perform activities of daily living. No difference was observed at week 52 or 104 between the cohorts.
3.5.3. Ability to Carry out Usual Activities
Data were available for n = 46 participants from the UK cohort and n = 15 participants from the Dublin cohort. At baseline, there was no difference between the UK or Dublin cohorts in terms of the participants’ ability to carry out usual activities. No difference was observed at week 52 or 104 between cohorts. At week 52, 26.2% of all the participants reported a decline in their ability to carry out day-to-day tasks from baseline, which was associated with weight gain from baseline.
3.5.4. Pain
Data were available for n = 45 from the UK cohort and n = 15 from the Dublin cohort. At baseline, there was no difference between UK or Dublin cohorts in self-rated pain/discomfort. No difference was observed at week 52 or 104 between cohorts. At week 52, 33.3% of all the participants had worsening in their self-reported pain/discomfort, which was associated with weight gain from baseline. A further 21.7% reported worsening from week 52 to 104, which was associated with more weight gain from week 52 to 104.
3.5.5. Mobility
Data were available for n = 45 from the UK cohort and n = 15 from the Dublin cohort. At baseline, there was no difference between the UK and Dublin cohorts in self-rated mobility challenges. No difference was observed at week 52 or 104 between cohorts. At week 52, 30.0% of all the participants had worsening in their self-reported mobility, which was associated with weight gain from baseline. A further 16.7% reported deterioration from week 52 to 104. This was associated with weight gain from week 52 to 104.
3.6. Changes in Parameters Relating to Complications of Obesity
3.6.1. Diabetes Onset
At weeks 52 and 104, no participants in the Dublin cohort developed new-onset diabetes, as defined by a HbA1c > 48 mmol/mol (Tabel 3). In the UK cohort, 3.3% (n = 3) developed new-onset diabetes at week 52, which was associated with a weight gain of 2.1% from baseline. At week 104, a further 3.3% (n = 3) from the UK cohort developed new-onset diabetes. This was associated with a weight gain of 3.2% between weeks 52 and 104.
3.6.2. Cardiometabolic Risk Factors
From baseline, more participants in the Dublin cohort had HTN than in the UK cohort (p < 0.05), but there was no difference in the use of antihypertensive medications. The participants in the Dublin cohort had higher systolic (p = 0.01) and diastolic (p = 0.004) blood pressure at baseline. However, by week 52, there were no differences in the development or remission of HTN between cohorts.
4. Discussion
The Dublin cohort lost 4.9% more weight than the UK cohort. The reasons for this may partly relate to the use of meal replacements for breakfast and lunch as part of usual care in the Dublin cohort. Previous work from the Glasgow site on complete meal-replacement intervention also demonstrated a higher proportional WL with this intervention than with food-based caloric restriction [12].
Socioeconomic factors may also play an important role, as the majority of participants within the Dublin cohort were domiciled within commuting distance of the clinical trial site, which was situated in an affluent part of Dublin. Lower socioeconomic status has previously been shown to be a hindrance in adherence to lifestyle intervention programmes [13]. Furthermore, given the nature of a clinical trial, people of higher socioeconomic and educational status are more likely to be recruited and to display positive outcomes [14]. The trial sites within the UK had greater heterogeneity in terms of socioeconomic considerations given the variation in site locations.
Participants in the Dublin cohort were, on average, 5 years older than those in the UK cohort. Current evidence on the implications of age in WL is mixed and context-dependent. Older patients may have a greater response to lifestyle intervention [15]. One of the limitations of the use of WL as a measure of health gain in obesity care is that it does not encompass changes in muscle mass. With increasing age comes an increasing risk of sarcopenia, notably during periods of WL [16]. Thus, one of the limitations to the interpretation of WL in this older cohort is the inability to control for absolute body-composition changes beyond waist circumference. Protein intake, which can be increased with meal replacements, and strength training remain important protective factors for preventing muscle loss in sarcopenic obesity [17]. In addition to age and socioeconomic status, other baseline differences between the cohorts—such as lower BMIs and lower rates of self-reported anxiety or depression in the Dublin group—may have influenced the observed outcomes. These imbalances were not adjusted for in the analysis, and thus represent potential confounding factors. While the use of meal replacements likely contributed to the greater WL in the Dublin cohort, it is also possible that differences in baseline health status, psychological wellbeing, or readiness to engage in treatment played a role. These factors should be considered when interpreting the findings of this post hoc analysis.
Secondary Outcomes
The Dublin cohort had greater improvements in glycaemic control at weeks 52 and 104 (p = 0.02). The greater WL is a possible explanation, especially as more patients achieved >10% WL in the Dublin cohort, which may be sufficient to disrupt type 2 diabetes, but also to prevent the development of type 2 diabetes [18].
The Dublin cohort had more HTN at baseline and at weeks 52 and 104, despite having more WL and no difference in medication use. This would suggest that WL achieved through a non-pharmacological approach has a minor effect on treating the disease of HTN. More WL may have been needed. Our study may be underpowered to detect the association between WL and improvement in blood pressure, because we had too few patients who achieved more than 10% WL within the standard-care arm.
Despite the greater WL in the Dublin participants, there were no differences during follow-up in anxiety, depression, ability to perform self-care, activities of daily living, ability to carry out usual activities, pain, and mobility. This may be a type II statistic error due to the sample size, or it may be due to the fact that the Dublin cohort started with a good baseline, thus making improvements less easy to observe.
An important limitation of this post hoc analysis is that the study design did not set out to compare different strategies for the standard-care arm. However, this is also a strength, because all centres used their own standard care, and hence it reflected real-world evidence. Even though there was a difference in the WL achieved, the effect size of the WL was not sufficient to result in major changes as regards the complications of obesity. The study was underpowered to show changes in HTN, type 2 diabetes, and quality of life measures, although the trends associated with greater WL in the Dublin cohort were consistent with the expected effect on obesity complications. The lack of more detailed body composition analysis was a major limitation, and this should be included in future studies.
In conclusion, while there were modest differences observed pre-intervention between the Dublin and UK cohorts, the Dublin cohort randomised to the standard-care arm did lose more weight than the UK cohort. The reasons for this may relate to variation in socioeconomic status and or the use of meal replacements. People living with obesity should be informed that standard lifestyle treatments with or without meal replacements remain a valid treatment option, but the percentage of patients who lose more than 15% body weight at 52 weeks or more than 10% bodyweight at 104 weeks remains below 20%.
Author Contributions
W.A.-N.: investigation; project administration; writing—review and editing. AI: investigation; project administration; writing—review and editing. B.D.: investigation; project administration. A.W.A.-H.: investigation; project administration. D.H.B.: formal analysis; data curation; data verification; methodology, writing—review and editing. D.P.: co-investigator; conceptualisation; literature search; data verification; methodology; investigation; visualisation. M.L.: primary investigator; conceptualisation; investigation; writing—review and editing. B.M.: primary investigator; conceptualisation; methodology; investigation; supervision; writing—review and editing. D.R.W.: primary investigator; investigation; methodology; writing—review and editing. J.P.W.: primary investigator; conceptualisation; investigation; methodology; supervision; writing—review and editing. M.J.D.: chief investigator; conceptualisation; methodology; data verification; funding acquisition; supervision; writing—review and editing. C.W.l.R.: primary investigator; conceptualisation; methodology; supervision; writing—review and editing. All authors have read and agreed to the published version of the manuscript.
Funding
Novo Nordisk provided funding for this investigator-initiated study and had no role in the study design, data collection, data analysis, data interpretation, or writing of this work.
Institutional Review Board Statement
Approval for the protocol (and any subsequent substantial amendments) was obtained from the Medicines and Healthcare products Regulatory Agency (MHRA, UK Competent authority) and the Health Products Regulatory Authority (HRPA, Irish Competent Authority). This protocol was approved by the Health Research Authority (HRA), and ethical approval as a Clinical Trial of an Investigational Medicinal Product (CTIMP) study was granted by the North West Deanery National Research Ethics Service (NRES) committee (17/NW/0517) in the UK (29 September 2017) and by the St Vincent’s University Hospital European Research Ethics Committee (EUREC) (2017-002998-20) in Ireland (2017-11-28). The study was conducted in accordance with the principles laid down by the 18th World Medical Assembly (Helsinki, 1964) and all applicable amendments laid down by the World Medical Assemblies, as well as in full conformity with the International Conference of Harmonisation (ICH) Guidelines for Good Clinical Practice (CPMP/ICH/135/95) July 1996. Ethical and research governance approval was obtained for this study from the HRA, appropriate regulatory bodies, and the National Health Service (NHS) Trust prior to any participant activity.
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
Data Availability Statement
The original contributions presented in this study are included in the article. Further inquiries can be directed to the corresponding author(s).
Acknowledgments
This research was funded by an investigator-initiated grant from Novo Nordisk A/S. Prefilled liraglutide pens were provided by Novo Nordisk. Leicester Clinical Trials Unit provided statistical and database support for the trial. In Leicester, the research was carried out at the National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre (BRC). During the course of the study, DP was funded by an NIHR Clinical Lectureship. The authors would also like to thank all members of the Data and Safety Monitoring Committee and the Trial Steering Committee, as well as the research participants, for their valuable contributions. The views expressed are those of the authors, and not necessarily those of the UK NHS or NIHR.
Conflicts of Interest
W.A.-N. does not report any conflicts of interest. B.D. does not report any conflicts of interest. A.A.-H. does not report any conflicts of interest. D.H.B. is an independent consultant who is contracted to work on projects, including those in relation to obesity and diabetes. D.P. has received travel and meeting support from Novo Nordisk and honoraria for lectures from Novo Nordisk, Eli Lilly, Boehringer Ingelheim, and Johnson and Johnson. D.P. also reports grants from Novo Nordisk, the Novo Nordisk UK Research Foundation, the Academy of Medical Sciences/Diabetes UK, Health Education East Midlands, and the National Institute for Health and Care Research (NIHR). D.P. is also a Trustee for the Association of the Study of Obesity (ASO) and a member of the academic subcommittee of the Association of the British Clinical Diabetologists (ABCD). M.L. reports grants from Novo Nordisk, the National Institute for Health Care and Research (NIHR), All Saints Educational Trust, and Diabetes UK. M.L. also reports honoraria from Novo Nordisk, Eli Lilly, and Nestle, as well as consulting fees from Counterweight Ltd., and has received support for attending meetings and/or travel from the EASD nutritional study group. B.M. is a shareholder of Reset Health and reports honoraria from Novo Nordisk and Janssen, and she has received support for attending meetings or travel from Novo Nordisk. B.M. also reports a grant from Novo Nordisk and consulting fees from Novo Nordisk, Prizer, and Johnson and Johnson. B.M. is the Chair of Obesity Management Collaborative- UK and co-chair of the EASO Task Force. D.R.W. reports research funding support from Novo Nordisk and the National Institute for Health Care and Research (NIHR). D.R.W. is also chairing the data and safety monitoring committee for an investigator-initiated study funded by Novo Nordisk. JPHW reports consultancy/advisory board work contracted via the University of Liverpool (no personal payment) for Altimmune, Astra- Zeneca, Boehringer Ingelheim, Lilly, Cytoki, Napp, Novo Nordisk, Menarini, Mundipharma, Pfizer, Rhythm Pharmaceuticals, Sanofi, Saniona, Tern, Shionogi, and Ysopia in relation to obesity and type 2 diabetes. J.P.W. is named grantholder (at the University of Liverpool) for research grants for clinical trials from AstraZeneca and Novo Nordisk, and has received fees for clinical trials (at Liverpool University Hospitals NHS Foundation Trust) from Novo Nordisk, Lilly, and Rhythm Pharmaceuticals. J.P.W. reports personal lecture fees from AstraZeneca, Boehringer Ingelheim, Napp, Medscape, and Novo Nordisk in relation to lectures on diabetes and/or obesity, and has received support for attending meeting or travel from Novo Nordisk. J.P.W. reports editorial work for Springer Nature (Medicine Matters Diabetes website), and he was a past president of the World Obesity Federation and a board member of the World Obesity Federation. J.P.W. also reports fees (paid to University of Liverpool) from AstraZeneca for being a Data and Safety Monitoring Board member for a clinical trial, and he is also the speciality lead for the Metabolic and Endocrine Specialty Group of the NIHR Clinical Research Network, a member of the Rank Prize Funds Nutrition Committee, a previous member of the RCP committee on Nutrition, Weight and Health, and an advisor on obesity treatments for NICE. M.J.D. reports consulting fees from Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Sanofi, and honoraria for lectures from Eli Lilly, Sanofi Aventis, Boehringer Ingelheim, Novo Nordisk, AstraZeneca, Novartis, Napp Pharmaceuticals, and Amgen. C.W.l.R. reports grants from the Irish Research Council, Science Foundation Ireland, Anabio, and the Health Research Board. He serves on the advisory boards of Novo Nordisk, Herbalife, GI Dynamics, Eli Lilly, Johnson & Johnson, Altimmune, Irish Life Health, and Boehringer Ingelheim, and reports honoraria for presentations from Novo Nordisk, Herbalife, Johnson and Johnson, Eli Lilly, Boehringer Ingelheim, Rhythm Pharmaceuticals, and Currax Pharmaceuticals. C.W.l.R. has received support to attend meetings and/or travel from Novo Nordisk, Herbalife, Johnson and Johnson, Eli Lilly, and Boehringer Ingelheim. C.W.l.R. is a member of the Irish Society for Nutrition and Metabolism outside the area of work commented on here. He was the previous chief medical officer and director of the Medical Device Division of Keyron in 2021. Both of these were unremunerated positions. C.W.l.R. was a previous investor in Keyron, which develops endoscopically implantable medical devices intended to mimic the surgical procedures of sleeve gastrectomy and gastric bypass. The product has only been tested in rodents, and none of Keyron’s products are currently licenced. They do not have any contracts with other companies to put their products into clinical practice. No patients have been included in any of Keyron’s studies, and they are not listed on the stock market. C.W.l.R. was gifted stock holdings in September 2021 and divested all stock holdings in Keyron in September 2021. He continues to provide scientific advice to Keyron for no remuneration. C.W.l.R. also provides services to Beyond BMI, a private obesity clinic providing obesity care. M.J.D. has received grants in support of investigations and investigator-initiated trials from Novo Nordisk, Sanofi Aventis, Eli Lilly, Boehringer Ingelheim, Astra-zeneca, and Janssen.
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Table 1.
Summary of categorical baseline characteristics.
| 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 | |
Table 2.
Summary of continuous baseline characteristics.
| 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 |
1. UK sites included Glasgow (n = 9), Leicester (n = 30), Liverpool (n = 26), and London (n = 27). Standard Deviation (SD). p-value compares mean value of “UK cohort” and “Dublin cohort”.
Table 3.
Summary of primary and secondary outcomes at 52 weeks and 104 weeks.
| 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
AMA Style
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
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