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The impact of low-energy total diet replacement with behavioural support for remission of type 2 diabetes on disordered eating (ARIADNE): Protocol for a non-inferiority randomised controlled trial.
Tsompanaki, E, Aveyard, P, Park, RJ, Koutoukidis, DA
Contemporary clinical trials. 2024;:107542
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INTRODUCTION The National Health Service (NHS) in England is currently piloting a weight loss programme for remission of newly diagnosed type 2 diabetes (T2D), where participants replace all food with low-energy nutritionally complete formula products for 12 weeks (total diet replacement, TDR) and receive behavioural support. In a clinical trial, this programme led to remission in nearly half the participants. However, this weight loss programme might also worsen disordered eating and prompt eating disorders in susceptible people. We aim to investigate if the TDR programme is non-inferior to standard care in terms of disordered eating in susceptible individuals. METHODS Fifty six people with newly diagnosed T2D, BMI ≥ 27 kg/m2, and medium to high scores of disordered eating based on the Eating Disorders Examination questionnaire (EDE-Q) will be randomised 1:1 to TDR receiving remote weekly/bi-weekly dietetic support or standard care. Participants will be re-assessed remotely at 1, 3, 4, 6, and 12 months. The primary outcome will be the between-group difference in the score of the EDE-Q. If the sample size can be expanded to 150, we will reduce the non-inferiority boundary. Weight, glycated haemoglobin (HbA1c), impairment from disordered eating, and distress will be secondary outcomes. Using the recorded consultations, we will evaluate the process in observed changes in eating behaviour and disordered eating. CONCLUSIONS If TDR for T2D remission is deemed non-inferior to standard care, more people may enrol and benefit from T2D remission. If TDR exacerbates disordered eating, screening may reduce unintended harm. TRIAL REGISTRATION NCT05744232 (ClinicalTrials.gov, prospectively registered).
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Effect of planned pauses versus continuous energy restriction on weight loss and attrition: a systematic review.
Wren, GM, Koutoukidis, DA, Scragg, J, Tsompanaki, E, Hobson, A, Jebb, SA
Obesity (Silver Spring, Md.). 2024;(3):454-465
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OBJECTIVE The objective of this study was to investigate whether pausing a weight loss program for a defined period of time could enhance weight loss and reduce attrition. METHODS Five databases and two trial registries were searched from inception to July 2023. Randomized-controlled trials of adults with overweight and/or obesity were included if they compared planned-pause interventions with continuous energy restriction (CER), usual care, or a minimal intervention. To be included, the weight loss intervention must have incorporated a pause of at least 1 week. Pooled mean differences for weight change and risk ratios for attrition were calculated using random-effects meta-analyses. RESULTS Nine intervention arms (N = 796 participants, 77% female) were included. Pooled results did not detect a significant difference in weight change between planned pauses and CER interventions at the end of the active intervention at a median 26 weeks (planned pauses vs. CER mean: -7.09 vs. -7.0 kg; mean difference: -0.09 kg; 95% CI: -1.10 to 0.93) or at final follow-up at a median 52 weeks (planned pauses vs. CER mean: -6.91 vs. -6.19 kg; mean difference: -0.72 kg; 95% CI: -2.92 to 1.48). There was no difference in attrition between planned pauses and CER interventions at the end of the active intervention (risk ratio: 1.20, 95% CI: 0.82 to 1.75) or at final follow-up (risk ratio: 1.04, 95% CI: 0.89 to 1.22). CONCLUSIONS Planned pauses were consistently found to be no more or less effective than CER for weight loss or attrition.
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Participants' perspectives of being recruited into a randomised trial of a weight loss intervention before colorectal cancer surgery: a qualitative interview study.
Talbot, A, Jebb, SA, Foster, C, Realpe, AX, Wheatstone, P, Buczacki, S, Koutoukidis, DA
BMC cancer. 2024;(1):802
Abstract
BACKGROUND The period between cancer diagnosis and surgery presents an opportunity for trials to assess the feasibility of behaviour change interventions. However, this can be a worrying time for patients and may hinder recruitment. We describe the perspectives of patients with excess weight awaiting colorectal cancer surgery about their recruitment into a randomised trial of a prehabilitation weight loss intervention. METHODS We interviewed the first 26 participants from the 8 recruitment sites across England in the 'CARE' feasibility trial. Participants were randomised into either usual care (n = 13) or a low-energy nutritionally-replete total diet replacement programme with weekly remote behavioural support by a dietitian (n = 13). The semi-structured interviews occurred shortly after recruitment and the questions focused on participants' recollections of being recruited into the trial. We analysed data rapidly and then used a mind-mapping technique to develop descriptive themes. Themes were agreed by all co-authors, including a person with lived-experience of colorectal surgery. RESULTS Participants had a mean body mass index (± SD) of 38 kg/m2 (± 6), age of 50 years (± 12), and 42% were female. People who participated in the trial were motivated by the offer of structured weight loss support that could potentially help them improve their surgical outcomes. However, participants also had concerns around the potential unpalatability of the intervention diet and side effects. Positive attitudes of clinicians towards the trial facilitated recruitment but participants were disappointed when they were randomised to usual care due to clinical teams' overemphasis on the benefits of losing weight. CONCLUSIONS Patients were motivated to take part by the prospect of improved surgical outcomes. However, the strong preference to be allocated to the intervention suggests that balanced communication of equipoise is crucial to minimise disappointment from randomisation to usual care and differential dropout from the trial. CLINICAL TRIAL REGISTRATION ISRCTN39207707, Registration date 13/03/2023.
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CARE: Protocol of a randomised trial evaluating the feasibility of preoperative intentional weight loss to support postoperative recovery in patients with excess weight and colorectal cancer.
Koutoukidis, DA, Jebb, SA, Foster, C, Wheatstone, P, Horne, A, Hill, TM, Taylor, A, Realpe, A, Achana, F, Buczacki, SJA
Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland. 2023;(9):1910-1920
Abstract
AIM: Excess weight increases the risk of morbidity following colorectal cancer surgery. Weight loss may improve morbidity, but it is uncertain whether patients can follow an intensive weight loss intervention while waiting for surgery and there are concerns about muscle mass loss. The aim of this trial is to assess the feasibility of intentional weight loss in this setting and determine progression to a definitive trial. METHODS CARE is a prospectively registered, multicentre, feasibility, parallel, randomised controlled trial with embedded evaluation and optimisation of the recruitment process. Participants with excess weight awaiting curative colorectal resection for cancer are randomised 1:1 to care as usual or a low-energy nutritionally-replete total diet replacement programme with weekly remote behavioural support by a dietitian. Progression criteria will be based on the recruitment, engagement, adherence, and retention rates. Data will be collected on the 30-day postoperative morbidity, the typical primary outcome of prehabilitation trials. Secondary outcomes will include, among others, length of hospital stay, health-related quality of life, and body composition. Qualitative interviews will be used to understand patients' experiences of and attitudes towards trial participation and intervention engagement and adherence. CONCLUSION CARE will evaluate the feasibility of intensive intentional weight loss as prehabilitation before colorectal cancer surgery. The results will determine the planning of a definitive trial.
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Association of changes in histologic severity of nonalcoholic steatohepatitis and changes in patient-reported quality of life.
Heath, L, Aveyard, P, Tomlinson, JW, Cobbold, JF, Koutoukidis, DA
Hepatology communications. 2022;(10):2623-2633
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Nonalcoholic steatohepatitis (NASH) is a prevalent chronic disease that is associated with a spectrum of liver fibrosis and can lead to cirrhosis. Patients with NASH report lower health-related quality of life (HRQoL) than the general population. It remains uncertain how changes in histologic severity are associated with changes in HRQoL. This is a secondary analysis of the Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment (FLINT) and Pioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis (PIVENS) randomized controlled trials in patients with biopsy-proven NASH. HRQoL was assessed using short form-36 at baseline and at follow-up biopsy (at 72 and 96 weeks, respectively). Adjusted linear regression models were used to examine the association between changes in liver fibrosis (primary analysis), nonalcoholic fatty liver disease (NAFLD) activity score (secondary analysis), and changes in HRQoL scores. Compared with stable fibrosis, improvement of fibrosis by at least one stage was significantly associated with improvements only in the physical function component by 1.8 points (95% confidence interval, 0.1, 3.5). Worsening of fibrosis by at least one stage was not associated with statistically significant changes in any HRQoL domain compared with stable fibrosis. Associations between HRQoL and NAFLD disease activity score in the secondary analysis were of similar magnitude. Weight loss was associated with small improvements in physical function, general health, and energy levels. Conclusion: Improvements in fibrosis stage were associated with improvements in the physical component of HRQoL, but the clinical impact was modest. As improving fibrosis may not meaningfully improve well-being, treatment for NASH will be cost effective only if it prevents long-term hepatic and cardiovascular disease.
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The association of weight loss with changes in the gut microbiota diversity, composition, and intestinal permeability: a systematic review and meta-analysis.
Koutoukidis, DA, Jebb, SA, Zimmerman, M, Otunla, A, Henry, JA, Ferrey, A, Schofield, E, Kinton, J, Aveyard, P, Marchesi, JR
Gut microbes. 2022;(1):2020068
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The gut microbiome may be a mediator between obesity and health outcomes. However, it is unclear how intentional weight loss changes the gut microbiota and intestinal permeability. We aimed to systematically review and quantify this association. We searched Medline, Embase, CINAHL, Cochrane databases, and trial registries until June 2020 (PROSPERO CRD42020205292). We included trials of weight loss interventions (energy-restricted diets, pharmacotherapy, bariatric surgery) reporting on the microbiome. Two reviewers independently completed screening, extraction, and risk assessment with the ROBINS-I tool. Pooled standardized mean differences (SMDs) were obtained from random-effects meta-analyses. Forty-seven trials with 1,916 participants (81% female) and a median follow-up of 6 months (range: 2-24) were included. Based on imprecise evidence but with fairly consistent direction of effect, weight loss was associated with a statistically significant increase in α-diversity [SMD: 0.4 (95% CI: 0.2, 0.6], p < .0001, I2 = 70%, n = 30 studies) and a statistically significant reduction in intestinal permeability [SMD: -0.7 (95% CI: -0.9, -0.4), p < .0001, I2 = 83%, n = 17 studies]. Each kg of weight loss was associated with a 0.012 (95% CI: 0.0003, 0.024, p = .045) increase in α-diversity and a -0.017 (95% CI: -0.034, -0.001, p = .038) reduction in intestinal permeability. There was clear evidence of increases in the relative abundance of Akkermansia, but no clear evidence of changes in individual phyla, species, or fecal short-chain fatty acids. Restricting the analyses to the studies with lower risk of bias did not materially alter the estimates. Increasing weight loss is positively associated with increases in gut microbiota α-diversity and reductions in intestinal permeability.
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Identifying and measuring the behavioural, dietary, and physical activity components of weight management consultations delivered by general practice nurses in routine care.
Tong, H, Morris, E, Jebb, SA, Koutoukidis, DA
BMC family practice. 2021;(1):65
Abstract
BACKGROUND Many people with obesity receive weight loss consultations by general practice nurses (GPNs) in routine primary care. This exploratory study aimed to characterise the components of these consultations, including behaviour change techniques (BCTs), and dietary and physical activity recommendations. METHODS We analysed audio recordings of weight management consultations conducted by 8 GPNs as part of the 'usual care' group in a randomised controlled trial (ISRCTN75092026). Consultations were coded against three taxonomies to classify BCTs, dietary recommendations, and physical activity recommendations. Associations between coded content and weight loss were assessed. Differences in the content of consultations where weight loss was < 5% or ≥ 5% from baseline weight at 6 months were explored. RESULTS One hundred and fifty audio recordings were available from 53 out of 140 (38%) participants in the usual care group. Participants had on average 3 (SD = 1) recorded consultations over 3 months, lasting 14 (SD = 7) minutes each. Weight change at 3, 6, and 12 months was -3.6% (SD = 4.3), -5.5% (SD = 6.0) and -4.2% (SD = 6.5) for participants with audio recordings. GPNs used 3.9 (SD = 1.6) of 93 BCTs, 3.3 (SD = 2.7) of 30 dietary recommendations and 1.4 (SD = 1.2) of 10 physical activity recommendations per consultation. The most commonly employed BCTs were feedback on outcome of behaviour (80.0%), problem solving (38.0%), and social reward (34.3%). The most common dietary recommendations were about portion size (31.3%), nutrients (28.0%), and balanced diet (19.7%). The main physical activity recommendation was about walking (30.3%). There was no association between weight loss and the number of dietary recommendations, physical activity recommendations, or BCTs used per consultation, or per participant. Social reward was the only technique used significantly more in consultations of participants that lost ≥ 5% of their baseline weight at 6 months. CONCLUSIONS The study provides a new method that could be used to describe the content of weight management consultations. Specific dietary or physical activity recommendations and BCTs were used infrequently and inconsistently in this group of GPNs. Although replication is required in larger samples, this may point to a weakness in current practice.
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The Effect of Moderate Weight Loss on a Non-Invasive Biomarker of Liver Fibrosis: A Randomised Controlled Trial.
Koutoukidis, DA, Jebb, SA, Aveyard, P, Astbury, NM
Obesity facts. 2020;13(2):144-151
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Non-alcoholic fatty liver disease covers a range of conditions from excess fat in the liver through inflammation and fibrosis, to advanced fibrosis, and cirrhosis. The Enhanced Liver Fibrosis (ELF) score is emerging as a promising blood biomarker for fibrosis. The aim of this study was to examine whether a community weight loss programme reduces ELF score over 12 months compared with a weight-loss intervention which is less effective. This study is a secondary analysis of a published randomised controlled trial. Participants (n=73) were equally randomised to a community weight loss programme (WeightWatchers) or usual care. Results indicate that there was no evidence of an effect of a community weight loss programme on changes in the ELF score and no association between weight loss and the ELF score in people who had, on average, an ELF score compatible with moderate fibrosis. Authors conclude that using the ELF test to assess weight loss treatment efficacy in improving liver fibrosis may be of limited value, thus biopsy remains the gold-standard assessment for liver fibrosis.
Abstract
BACKGROUND Referral to weight loss programmes is the only effective treatment for non-alcoholic fatty liver disease (NAFLD). Clinicians should advise weight loss and screen for liver fibrosis using the Enhanced Liver Fibrosis (ELF) score. AIM: To examine if the ELF score changes with weight loss. DESIGN AND SETTING Randomised controlled trial (ISRCTN85485463) in UK primary care during 2007-2008. METHOD Adults with a BMI of 27-35 kg/m2 and ≥1 risk factor for obesity-related disease were randomised to attend a community weight loss programme (n = 45) or receive usual weight loss advice from a practice nurse (n = 28). Weight and the ELF score were measured at baseline and 1 year. Analysis of covariance examined mean changes in the ELF score between groups and its relationship with weight loss. RESULTS Mean (SD) BMI was 31.10 kg/m2 (2.55) with evidence of moderate levels of liver fibrosis at baseline (mean ELF score: 8.93 [0.99]). There was no evidence that the community weight loss programme reduced the ELF score compared with usual care (difference +0.13 points, 95% CI: -0.25 to 0.52) despite greater weight loss (difference: -2.66 kg, 95% CI: -5.02 to -0.30). Mean weight loss in the whole cohort was 7.8% (5.9). There was no evidence of an association between weight change and change in ELF; the coefficient for a 5% weight loss was -0.15 (95% CI: -0.30 to 0.0002). CONCLUSION We found no evidence that the ELF score changed meaningfully following moderate weight loss. Clinicians should not use the ELF score to measure improvements in NAFLD fibrosis following weight loss programmes.
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Diet, physical activity, and health-related outcomes of endometrial cancer survivors in a behavioral lifestyle program: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomized controlled pilot trial.
Koutoukidis, DA, Beeken, RJ, Manchanda, R, Burnell, M, Ziauddeen, N, Michalopoulou, M, Knobf, MT, Lanceley, A
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society. 2019;(3):531-540
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OBJECTIVES To explore the effectiveness of a theory-based behavioral lifestyle intervention on health behaviors and quality of life in endometrial cancer survivors.' METHODS This was a secondary analysis of a randomized controlled pilot trial conducted in two UK hospitals enrolling disease-free stage I-IVA endometrial cancer survivors. Participants were allocated to an 8-week group-based healthy eating and physical activity intervention or usual care using 1:1 minimization. Participants were followed up at 8 and 24 weeks, with the 8-week assessment being blinded. Diet, physical activity, and quality of life were measured with the Alternative Healthy Eating Index 2010, Stanford 7-Day Physical Activity Recall, and the EORTC Quality of life Questionnaire Core 30, respectively. We analyzed all eligible participants using the intention-to-treat approach in complete cases, adjusting for baseline values, body mass index, and age. RESULTS We enrolled 60 of the 296 potentially eligible endometrial cancer survivors (May - December 2015). Fifty-four eligible participants were randomized to the intervention (n=29) or usual care (n=31), and 49 had complete follow-up data (n=24 in the intervention and n= 25 in usual care). Intervention adherence was 77%. At 8 weeks, participants in the intervention improved their diet compared to usual care (difference in Alternative Healthy Eating Index 2010 score 7.5 (95% CI: 0.1 to 14.9), P=0.046) but not their physical activity (0.1 metabolic equivalent-h/day 95% CI: (-1.6 to 1.8), P=0.879), or global quality of life score (5.0 (95% CI: -3.4 to 13.3), P=0.236). Global quality of life improved in intervention participants at 24 weeks (difference 8.9 (95% CI: 0.9 to 16.8), P=0.029). No intervention-related adverse events were reported. CONCLUSIONS The potential effectiveness of the intervention appeared promising. A future fully-powered study is needed to confirm these findings. TRIAL REGISTRATION NUMBER NCT02433080.
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Effects of weight stigma in news media on physical activity, dietary and weight loss intentions and behaviour.
Lambert, ER, Koutoukidis, DA, Jackson, SE
Obesity research & clinical practice. 2019;(6):571-578
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OBJECTIVES To investigate the effect of weight stigma in news media on (a) intentions to increase physical activity (PA), improve diet quality and lose weight, and (b) changes in PA, diet quality and body mass index (BMI) over one month, in (i) women of all weight categories and (ii) a subsample of women living with obesity. METHODS UK-based women (N=172; subgroup with obesity N=81) were assigned to read an experimental (weight stigma; N=75) or control (smoking stigma; N=97) news article. Questionnaires were administered immediately after, and one month subsequently to collect information on BMI, PA, diet quality, intentions, past stigma, and diet and PA self-efficacy. Logistic and linear regression analyses were used to assess the effect of weight stigma on all outcome variables. RESULTS In the whole sample, there was no significant effect of weight stigma on any primary or secondary outcome. In women with obesity, there was no significant effect of weight stigma on diet quality (0.26 units, 95% CI: -0.36 to 0.87) or PA (-1.83 units, 95% CI: -11.11 to 7.44) at follow up, but exposure to weight stigma was associated with a significant increase in BMI at 1-month follow-up (1.15kg/m2, 95% CI: 0.38 to 1.92) compared with the control group. CONCLUSIONS In people with obesity, exposure to weight-stigmatising media may contribute to increased BMI over time. Larger trials with longer follow-up are needed to confirm these findings.
