scholarly journals Design of a randomised controlled trial: does indirect calorimetry energy information influence weight loss in obesity?

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044519
Author(s):  
Jonathan Lim ◽  
Uazman Alam ◽  
Daniel Cuthbertson ◽  
John Wilding
Keyword(s):  
Weight Loss ◽  
Energy Balance ◽  
Randomised Controlled Trial ◽  
Weight Management ◽  
Indirect Calorimetry ◽  
Peptide Yy ◽  
Controlled Trial ◽  
Negative Energy ◽  
Negative Energy Balance ◽  
Randomised Controlled

IntroductionRespiratory quotient (RQ) provides an indication of the relative balance of carbohydrate and fat oxidation. RQ could serve as an early biomarker of negative energy balance during weight loss. Restriction of energy intake relative to total daily energy requirements produces a negative energy balance which can lead to a fall in RQ, accompanied by a decrease in resting energy expenditure (REE). However, the net change in body weight does not usually match predicted weight change due to intraindividual metabolic adaptations. Our aim is to determine the effectiveness of utilising EE information from indirect calorimetry during weight loss intervention.Methods and analysisWe will undertake an assessor-blinded, parallel-group randomised controlled trial of 105 adults with obesity randomised in 1:1 ratio to receive either standard weight management care (SC) or EE information plus SC (INT) during a 24-week multicomponent weight management programme. The primary outcome is difference in weight loss between INT and SC group at 24 weeks. Secondary outcomes include: change in RQ, REE, glycaemic variability, and appetite-relating gut hormones (glucagon-like peptide 1, gastric inhibitory polypeptide, peptide YY). Generalised linear mixed models (intention to treat) will assess outcomes for treatment (INT vs SC), time (baseline, 24 weeks) and the treatment-by-time interaction. This will be the first study to evaluate impact of utilising measured REE and RQ on the lifestyle-based intensive intervention programme.Ethics and disseminationEthics approval was obtained from the Health Research Authority and the North West Research Ethics Committee (18/NW/0645). Results from this trial will be disseminated through publication in peer-reviewed journals, national and international presentations.Trial registration numbersNCT03638895; UoL001379.

The effect of rate of weight loss on long-term weight management: a randomised controlled trial

2014 ◽  
Vol 2 (12) ◽  
pp. 954-962 ◽  
Author(s):  
Katrina Purcell ◽  
Priya Sumithran ◽  
Luke A Prendergast ◽  
Celestine J Bouniu ◽  
Elizabeth Delbridge ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Weight Management ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals Thrifty energy phenotype predicts weight regain - results of a randomized controlled trial

2021 ◽  
Author(s):  
Leonard Spranger ◽  
Josephine Bredow ◽  
Ulrike Zeitz ◽  
Ulrike Grittner ◽  
Michael Boschmann ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Insulin Sensitivity ◽  
Energy Balance ◽  
Fat Mass ◽  
Controlled Trial ◽  
Intervention Group ◽  
Negative Energy ◽  
Negative Energy Balance ◽  
Control Group

AbstractBackground & AimsWeight loss is associated with an improvement of insulin sensitivity. Both, a negative energy balance and changes of body composition are integrative components of weight loss interventions. However, the individual impact of these two components on insulin sensitivity and energy metabolism is unclear.MethodsWe performed a randomized controlled trial including 80 overweight or obese post-menopausal women. Participants randomly assigned to the intervention group underwent an 800 kcal/d liquid diet for 2 months followed by four weeks in which the formula diet was substituted by a calorie reduced healthy diet to facilitate further weight loss. This weight loss phase was followed by a 4-week weight maintenance phase, where weight stability was achieved by individualized daily caloric intake without negative energy balance. Volunteers of the control group were instructed to keep their weight stable during the entire period of 4 months. Metabolic phenotyping was performed in both groups at baseline (M0), after weight loss (M3) and after the maintenance period (M4). Additional phenotyping was performed during follow-up at 12 (M12) and 24 months (M24). Primary outcomes were changes of lean body mass (LBM) and changes of insulin sensitivity (ISIClamp) between baseline and M3 and M4. Estimates of energy metabolism were secondary endpoints.ResultsNo significant changes of body weight or LBM were found in the control group between any time points. A significant reduction of body weight, fat mass (FM) and LBM was found in the intervention group between M0 and M3, while no further change was seen between M3 and M4. Only subjects of the intervention group were characterized by an improvement of the second primary outcome ISIClamp at M3, which was preserved until M4. Notably, a lower resting energy expenditure per LBM (REELBM) at M3 as well as the individual difference of REELBM between M3 and M4 significantly predicted a stronger regain of fat mass during follow-up.ConclusionsIn summary, our data demonstrate that modulation of LBM and insulin sensitivity during weight loss is predominantly driven by changes in body weight and body composition, rather than an individual effect of negative energy balance. However, the variance in energy expenditure during negative and steady energy balance indicates a thrifty phenotype, which is highly susceptible to future regain of fat mass.

Revolutionising participants’ health and wellbeing through neuro-reprogramming via the Slimpod® app: a randomised controlled trial

2020 ◽  
Vol 70 (suppl 1) ◽  
pp. bjgp20X711701
Author(s):  
Richard Kyle ◽  
Stephen Jones ◽  
Sandra Roycroft-Davis
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Weight Management ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Eating Behaviours ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Overweight Adults

BackgroundObesity is a global pandemic that threatens the health of the population and the sustainability of publicly funded health care. This randomised controlled trial addresses the gap in the literature surrounding unconscious persuasion and its use in weight loss and weight management. The Slimpod® tool is unlike any of those currently available on the market. Using breakthrough research in ‘nudge’ thinking, it is designed to retrain an adult’s habitual and emotional response to foodstuffs. This therapeutic model allows unconscious thought to be shaped into a manner more consistent with a healthy lifestyle. Candidates can then take control of their eating behaviours to induce a holistic state of wellbeing.AimTo assess the effectiveness of an audio unconscious-persuasion weight loss/weight management intervention (Slimpod®) compared with audio relaxation (control).MethodEighty-two overweight adults were randomised to intervention (n = 41) and control groups (n = 41). Weight was assessed at trial commencement, mid-trial (12 weeks), and trial end (24 weeks). Secondary outcomes were assessed using the Eating Self-Efficacy Scale (ESES), Exercise Confidence Scale (ECS), and Quality of Life Index Generic Version III (QLI-G3) at the start and end of the trial.ResultsReports found a statistically significant difference in mean weight loss between intervention group (1.7 kg at 12 weeks and 4.3 kg at 24 weeks) versus control (0.6 kg and 1.2 kg respectively) at P<0.001. ESES scores showed greater self-efficacy (P = 0.008) in intervention at 24 weeks. No significant differences in ESES negative affect sub-scale score or ECS were observed.ConclusionSlimpod® was effective at reducing weight and increasing eating self-efficacy in overweight adults.

scholarly journals Doctor Referral of Overweight People to a Low-Energy Treatment (DROPLET) in primary care using total diet replacement products: a protocol for a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e016709 ◽  
Author(s):  
Susan A Jebb ◽  
Nerys M Astbury ◽  
Sarah Tearne ◽  
Alecia Nickless ◽  
Paul Aveyard
Keyword(s):  
Primary Care ◽  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Weight Management ◽  
Controlled Trial ◽  
Low Energy ◽  
Overweight People ◽  
Management Interventions ◽  
Total Diet ◽  
Randomised Controlled

IntroductionThe global prevalence of obesity has risen significantly in recent decades. There is a pressing need to identify effective interventions to treat established obesity that can be delivered at scale. The aim of the Doctor Referral of Overweight People to a Low-Energy Treatment (DROPLET) study is to determine the clinical effectiveness, feasibility and acceptability of referral to a low-energy total diet replacement programme compared with usual weight management interventions in primary care.Methods and analysisThe DROPLET trial is a randomised controlled trial comparing a low-energy total diet replacement programme with usual weight management interventions delivered in primary care. Eligible patients will be recruited through primary care registers and randomised to receive a behavioural support programme delivered by their practice nurse or a referral to a commercial provider offering an initial 810 kcal/d low-energy total diet replacement programme for 8 weeks, followed by gradual food reintroduction, along with weekly behavioural support for 24 weeks. The primary outcome is weight change at 12 months. The secondary outcomes are weight change at 3 and 6 months, the proportion of participants achieving 5% and 10% weight loss at 12 months, and change in fat mass, haemoglobin A1c, low-density lipoprotein cholesterol and systolic and diastolic blood pressure at 12 months. Data will be analysed on the basis of intention to treat. Qualitative interviews on a subsample of patients and healthcare providers will assess their experiences of the weight loss programmes and identify factors affecting acceptability and adherence.Ethics and disseminationThis study has been reviewed and approved by the National Health ServiceHealth Research Authority (HRA)Research Ethics Committee (Ref: SC/15/0337). The trial findings will be disseminated to academic and health professionals through presentations at meetings and peer-reviewed journals and to the public through the media. If the intervention is effective, the results will be communicated to policymakers and commissioners of weight management services.Trial registration numberISRCTN75092026.

scholarly journals The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 1042
Author(s):  
Nicholas Phillips ◽  
Julie Mareschal ◽  
Nathalie Schwab ◽  
Emily Manoogian ◽  
Sylvie Borloz ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Metabolic Health ◽  
Dietary Advice ◽  
Processed Food ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Weight loss is key to controlling the increasing prevalence of metabolic syndrome (MS) and its components, i.e., central obesity, hypertension, prediabetes and dyslipidaemia. The goals of our study were two-fold. First, we characterised the relationships between eating duration, unprocessed and processed food consumption and metabolic health. During 4 weeks of observation, 213 adults used a smartphone application to record food and drink consumption, which was annotated for food processing levels following the NOVA classification. Low consumption of unprocessed food and low physical activity showed significant associations with multiple MS components. Second, in a pragmatic randomised controlled trial, we compared the metabolic benefits of 12 h time-restricted eating (TRE) to standard dietary advice (SDA) in 54 adults with an eating duration > 14 h and at least one MS component. After 6 months, those randomised to TRE lost 1.6% of initial body weight (SD 2.9, p = 0.01), compared to the absence of weight loss with SDA (−1.1%, SD 3.5, p = 0.19). There was no significant difference in weight loss between TRE and SDA (between-group difference −0.88%, 95% confidence interval −3.1 to 1.3, p = 0.43). Our results show the potential of smartphone records to predict metabolic health and highlight that further research is needed to improve individual responses to TRE such as a shorter eating window or its actual clock time.

scholarly journals Efficacy of a Multi-Component m-Health Diet, Physical Activity, and Sleep Intervention on Dietary Intake in Adults with Overweight and Obesity: A Randomised Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2468
Author(s):  
Sasha Fenton ◽  
Tracy L. Burrows ◽  
Clare E. Collins ◽  
Anna T. Rayward ◽  
Beatrice Murawski ◽  
...  
Keyword(s):  
Physical Activity ◽  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Dietary Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Weight Loss Intervention ◽  
Traditional Group ◽  
Traditional Diet ◽  
Randomised Controlled

This three-arm randomised controlled trial evaluated whether (1) a multi-component weight loss intervention targeting diet, physical activity (PA), and sleep was effective at improving dietary intake over six months and 12 months, compared with a control, and (2) the enhanced diet, PA, and sleep intervention was more effective at improving dietary intake than the traditional diet and PA intervention. A total of 116 adults (70% female, 44.5 years, BMI 31.7 kg/m2) were randomised to either traditional diet and PA intervention; enhanced diet, PA, and sleep intervention; or wait-list control. To examine between-group differences, intervention groups were pooled and compared with the control. Then, the two intervention groups were compared. At six months, the pooled intervention group consumed 1011 fewer kilojoules/day (95% CI −1922, −101), less sodium (−313.2 mg/day; 95% CI −591.3, −35.0), and higher %EI from fruit (+2.1%EI; 95% CI 0.1, 4.1) than the controls. There were no differences in intake between the enhanced and traditional groups at six months. At 12 months, the pooled intervention and control groups reported no significant differences. However, compared to the traditional group, the enhanced reported higher %EI from nutrient-dense foods (+7.4%EI; 95% CI 1.3, 13.5) and protein (+2.4%EI; 95% CI 0.1, 4.6), and reduced %EI from fried/takeaway foods (−3.6%EI; 95% CI −6.5, −0.7), baked sweet products (−2.0%EI; 95% CI −3.6, −0.4), and packaged snacks (−1.1%EI; 95% CI −2.2, −0.3). This weight loss intervention reduced total energy and sodium intakes as well as increased fruit intake in adults at six months. The enhanced intervention group reported improved dietary intake relative to the traditional group at 12 months.

Erectile function improves in obese men following weight loss during the SHED-IT randomised controlled trial

2013 ◽  
Vol 7 ◽  
pp. e71
Author(s):  
Clare E. Collins ◽  
Megan Jensen ◽  
Myles D. Young ◽  
Robin Callister ◽  
Ron C. Plotnikoff ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Erectile Function ◽  
Controlled Trial ◽  
Randomised Controlled
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