scholarly journals Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study)

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e023207 ◽  
Author(s):  
Gaurav Singh Gulsin ◽  
Emer M Brady ◽  
Daniel J Swarbrick ◽  
Lavanya Athithan ◽  
Joseph Henson ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Composition ◽  
Exercise Capacity ◽  
Controlled Trial ◽  
Clinical Care ◽  
Cardiopulmonary Exercise Testing ◽  
Exercise Programme ◽  
Meal Replacement ◽  
Supervised Exercise ◽  
Study Results

IntroductionDespite their young age and relatively short duration of disease, younger adults with type 2 diabetes (T2D) already have diastolic dysfunction and may be at risk of incipient heart failure. Whether weight loss or exercise training improve cardiac dysfunction in people with T2D remains to be established.Methods and analysisProspective, randomised, open-label, blind endpoint trial. The primary aim of the study is to determine if diastolic function can be improved by either a meal replacement plan or a supervised exercise programme, compared with guideline-directed care. A total of 90 obese participants with T2D (aged 18–65 years), diabetes duration <12 years and not on insulin treatment will be randomised to either guideline-directed clinical care with lifestyle coaching, a low-energy meal replacement diet (average ≈810 kcal/day) or a supervised exercise programme for 12 weeks. Participants undergo glycometabolic profiling, cardiopulmonary exercise testing, echocardiography and MRI scanning to assesses cardiac structure and function and dual-energy X-ray absorptiometry scanning for body composition. Key secondary aims are to assess the effects of the interventions on glycaemic control and insulin resistance, exercise capacity, blood pressure, changes in body composition and association of favourable cardiac remodelling with improvements in weight loss, exercise capacity and glycometabolic control.Ethics and disseminationThe study has full ethical approval, and data collection was completed in August 2018. The study results will be submitted for publication within 6 months of completion.Trial registration numberNCT02590822; Pre-results.

scholarly journals Rationale and Protocol for a Randomized Controlled Trial Comparing Fast versus Slow Weight Loss in Postmenopausal Women with Obesity—The TEMPO Diet Trial

Healthcare ◽  
2018 ◽  
Vol 6 (3) ◽  
pp. 85 ◽  
Author(s):  
Radhika Seimon ◽  
Alice Gibson ◽  
Claudia Harper ◽  
Shelley Keating ◽  
Nathan Johnson ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Body Composition ◽  
Eating Disorder ◽  
Controlled Trial ◽  
Energy Restriction ◽  
Cardiometabolic Health ◽  
Meal Replacement ◽  
Randomized Controlled ◽  
Eating Disorder Behaviors

Very low energy diets (VLEDs), commonly achieved by replacing all food with meal replacement products and which result in fast weight loss, are the most effective dietary obesity treatment available. VLEDs are also cheaper to administer than conventional, food-based diets, which result in slow weight loss. Despite being effective and affordable, these diets are underutilized by healthcare professionals, possibly due to concerns about potential adverse effects on body composition and eating disorder behaviors. This paper describes the rationale and detailed protocol for the TEMPO Diet Trial (Type of Energy Manipulation for Promoting optimal metabolic health and body composition in Obesity), in a randomized controlled trial comparing the long-term (3-year) effects of fast versus slow weight loss. One hundred and one post-menopausal women aged 45–65 years with a body mass index of 30–40 kg/m2 were randomized to either: (1) 16 weeks of fast weight loss, achieved by a total meal replacement diet, followed by slow weight loss (as for the SLOW intervention) for the remaining time up until 52 weeks (“FAST” intervention), or (2) 52 weeks of slow weight loss, achieved by a conventional, food-based diet (“SLOW” intervention). Parameters of body composition, cardiometabolic health, eating disorder behaviors and psychology, and adaptive responses to energy restriction were measured throughout the 3-year trial.

The Weight Loss Effects of Branched Chain Amino Acids and Vitamin B6: A Randomized Controlled Trial on Obese and Overweight Women

2018 ◽  
Vol 88 (1-2) ◽  
pp. 80-89 ◽  
Author(s):  
Zahra Shakibay Novin ◽  
Saeed Ghavamzadeh ◽  
Alireza Mehdizadeh
Keyword(s):  
Amino Acids ◽  
Weight Loss ◽  
Body Composition ◽  
Vitamin B6 ◽  
Controlled Trial ◽  
Density Lipoprotein ◽  
Branched Chain Amino Acids ◽  
Model Assessment ◽  
Waist To Hip Ratio ◽  
Branched Chain

Abstract. Branched chain amino acids (BCAA), with vitamin B6 have been reported to improve fat metabolism and muscle synthesis. We hypothesized that supplementation with BCAA and vitamin B6 would result in more weight loss and improve body composition and blood markers related to cardiovascular diseases. Our aim was to determine whether the mentioned supplementation would affect weight loss, body composition, and cardiovascular risk factors during weight loss intervention. To this end, we performed a placebo-controlled randomized clinical trial in 42 overweight and obese women (BMI = 25–34.9 kg/m2). Taking a four-week moderate deficit calorie diet (–500 kcal/day), participants were randomized to receive BCAA (6 g/day) with vitamin B6 (40 mg/day) or placebo. Body composition variables measured with the use of bioelectrical impedance analysis, homeostatic model assessment, and plasma insulin, Low density lipoprotein, High density lipoprotein, Total Cholesterol, Triglyceride, and fasting blood sugar were measured. The result indicated that, weight loss was not significantly affected by BCAA and vitamin B6 supplementation (–2.43 ± 1.02 kg) or placebo (–1.64 ± 1.48 kg). However, significant time × treatment interactions in waist to hip ratio (P = 0.005), left leg lean (P = 0.004) and right leg lean (P = 0.023) were observed. Overall, supplementation with BCAA and vitamin B6 could preserve legs lean and also attenuated waist to hip ratio.

scholarly journals Supervised exercise rehabilitation in survivors of critical illness: A randomised controlled trial

2018 ◽  
Vol 20 (1) ◽  
pp. 18-26 ◽  
Author(s):  
Ceri Battle ◽  
Karen James ◽  
Paul Temblett ◽  
Hayley Hutchings
Keyword(s):  
Hospital Discharge ◽  
Controlled Trial ◽  
Unit Length ◽  
Exercise Programme ◽  
Anxiety And Depression ◽  
Six Minute Walk Test ◽  
Supervised Exercise ◽  
Randomised Controlled ◽  
Minute Walk

Objectives To investigate the impact of a six-week supervised exercise programme on cardiopulmonary fitness, balance, muscle strength and anxiety and depression in patients who have been discharged home from hospital following an intensive care unit length of stay of greater than 48 h. To investigate patients' perceptions of a six-week supervised exercise programme delivered at three months post hospital discharge. Design A single centre parallel, randomised controlled trial. Setting Outpatient department of a university teaching hospital in the UK. Participants Sixty adult survivors of critical illness, at three months post-hospital discharge. Intervention A six-week individually prescribed and supervised exercise program, with associated advice to home exercise modification. Twice weekly exercise sessions were individualised to participant's functional status and included cardiopulmonary, balance and strengthening exercises. Follow up at seven weeks, six months and 12 months. Outcome measures Six-Minute Walk Test, BERG balance test, grip strength and Hospital Anxiety and Depression Scale. A pre-designed survey was used to explore patient perceptions of the programme. Results Sixty participants ( n = 30 received allocated programme in both control and treatment groups) were randomised. Loss to follow up resulted in n = 34 participants for intention to treat analysis at 12 months follow up (leaving n = 19 in control group, n = 15 in treatment group). Median participant age at enrolment was 62 years (interquartile range: 49–72), with a median intensive care unit length of stay of nine days (interquartile range: 4–17). No significant differences were found for the Six-Minute Walk Test at any time point ( p > 0.05). Anxiety levels and balance were significantly improved in the treatment group at 12 months ( p = 0.006 and p = 0.040, respectively). Conclusions Further research is needed into appropriate interventions and outcome measures, target patient populations and timing of such intervention post-hospital discharge.

scholarly journals Evaluating differences in the clinical impact of a free online weight loss programme, a resource-intensive commercial weight loss programme and an active control condition: a parallel randomised controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Aidan Q. Innes ◽  
Greig Thomson ◽  
Mary Cotter ◽  
James A. King ◽  
Niels B. J. Vollaard ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Active Control ◽  
Body Mass ◽  
Controlled Trial ◽  
Free Access ◽  
Healthy Weight ◽  
Supervised Exercise ◽  
Weight Loss Programme ◽  
Randomised Controlled

Abstract Background Finding effective intervention strategies to combat rising obesity levels could significantly reduce the burden that obesity and associated non-communicable diseases places on both individuals and the National Health Service. Methods In this parallel randomised-controlled trial, 76 participants who are overweight or obese (50 female) were given free access to a fitness centre for the duration of the 12-week intervention and randomised to one of three interventions. The commercial intervention, the Healthy Weight Programme, (HWP, n = 25, 10/15 men/women) consisted of twelve 1-h nutrition coaching sessions with a nutritionist delivered as a mixture of group and 1 to 1 sessions. In addition, twice-weekly exercise sessions (24 in total) were delivered by personal trainers for 12 weeks. The NHS intervention (n = 25, 8/17 men/women) consisted of following an entirely self-managed 12-week online NHS resource. The GYM intervention (n = 26, 8/18 men/women) received no guidance or formal intervention. All participants were provided with a gym induction for safety and both the NHS and GYM participants were familiarised with ACSM physical activity guidelines by way of a hand-out. Results The overall follow-up rate was 83%. Body mass was significantly reduced at post-intervention in all groups (HWP: N = 18, − 5.17 ± 4.22 kg, NHS: N = 21–4.19 ± 5.49 kg; GYM: N = 24–1.17 ± 3.00 kg; p < 0.001) with greater reductions observed in HWP and NHS groups compared to GYM (p < 0.05). Out with body mass and BMI, there were no additional statistically significant time x intervention interaction effects. Conclusions This is the first study to evaluate the efficacy of both a free online NHS self-help weight-loss tool and a commercial weight loss programme that provides face-to-face nutritional support and supervised exercise. The findings suggest that both interventions are superior to an active control condition with regard to eliciting short-term weight-loss. Trial registration ISRCTN Registry - ISRCTN31489026. Prospectively registered: 27/07/16.

scholarly journals Effect of Two Meal Replacement strategies on Cardiovascular Risk Parameters in Advanced Age Patients with Obesity and Osteoarthritis

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 976 ◽  
Author(s):  
Juan José López-Gómez ◽  
Olatz Izaola-Jauregui ◽  
David Primo-Martín ◽  
Beatriz Torres-Torres ◽  
Emilia Gómez-Hoyos ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Weight Loss ◽  
Body Composition ◽  
Cardiovascular Risk ◽  
Systolic Blood Pressure ◽  
Fat Mass ◽  
The Body ◽  
Meal Replacement ◽  
Risk Parameters ◽  
Meal Replacements

Background and aims: Meal replacement diets consist of replacing one or more meals with an artificial nutritional supplement. The objective of this study was to compare the effect of one against two meal replacement strategies on body composition and cardiovascular risk parameters in patients with obesity. Methods: A randomized clinical trial was designed with a modified hypocaloric diet with an artificial nutritional preparation replacing one or two meals for three months in patients with obesity and osteoarthritis pending orthopedic surgery. An anthropometric evaluation and a measurement of the body composition were done with bioelectrical impedance measurement at the beginning and at three months. Results: A total of 112 patients were recruited. Fifty-two patients (46.4%) were randomized to one replacement and 60 patients (53.6%) to two meal replacements. Eighty-one patients (72.3%) were women, and the average age was 61 (11.03) years. The percentage of weight loss at three months was 8.27 (4.79)% (one meal replacement: 7.98 (5.97)%; two meal replacements: 8.50 (3.48)%; p = 0.56). A decrease in fat mass measured by the fat mass index (FMI) was detected (one meal replacement: −2.15 (1.45) kg/m2 vs. two meal replacements: −2.78 (2.55) kg/m2; p > 0.05), and a relative increase in fat-free mass was observed (one meal replacement: +3.57 (4.61)% vs. two meal replacements: +2.14 (4.45)%; p > 0.05). A decrease in HOMA-IR, systolic blood pressure (SBP), and total cholesterol was observed in both groups without differences between them. Conclusions: The substitution strategies of one or two meal replacements were effective in weight loss and fat mass decrease without differences between the two groups. An improvement in lipid parameters, glycemic control, and systolic blood pressure was observed without differences between strategies.

scholarly journals Examining the effects of enhanced provider–patient communication on postoperative tonsillectomy pain: protocol of a randomised controlled trial performed by nurses in daily clinical care

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e015505 ◽  
Author(s):  
Liesbeth M van Vliet ◽  
Sandra van Dulmen ◽  
Bram Thiel ◽  
Gerard W van Deelen ◽  
Stephanie Immerzeel ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Rating Scale ◽  
Controlled Trial ◽  
Clinical Care ◽  
Numeric Rating Scale ◽  
Study Results ◽  
Audio Recordings ◽  
Registration Number ◽  
Randomised Controlled ◽  
Care Ward

IntroductionPlacebo effects (true biopsychological effects not attributable to the active ingredients of medical technical interventions) can be attributed to several mechanisms, such as expectancy manipulation and empathy manipulation elicited by a provider’s communication. So far, effects have primarily been shown in laboratory settings. The aim of this study is to determine the separate and combined effects of expectancy manipulation and empathy manipulation during preoperative and postoperative tonsillectomy analgesia care on clinical adult patients’ outcomes.Methods and analysisUsing a two-by-two randomised controlled trial, 128 adult tonsillectomy patients will be randomly assigned to one out of four conditions differing in the level of expectancy manipulation (standard vs enhanced) and empathy manipulation (standard vs enhanced). Day care ward nurses are trained to deliver the intervention, while patients are treated via the standard analgesia protocol and hospital routines. The primary outcome, perceived pain, is measured via hospital routine by a Numeric Rating Scale, and additional prehospitalisation, perihospitalisation and posthospitalisation questionnaires are completed (until day 3, ie, 2 days after the operation). The manipulation is checked using audio recordings of nurse–patient interactions.Ethics and disseminationAlthough communication is manipulated, the manipulations do not cross norms or values of acceptable behaviour. Standard medical care is provided. The ethical committee of the UMC Utrecht and the local OLVG hospital committee approved the study. Results will be published via (inter)national peer-reviewed journals and a lay publication.Trial registration numberNTR5994; Pre-results.

scholarly journals Supervised Exercise Immediately After Bariatric Surgery: the Study Protocol of the EFIBAR Randomized Controlled Trial

2021 ◽  
Author(s):  
Enrique G. Artero ◽  
Manuel Ferrez-Márquez ◽  
María José Torrente-Sánchez ◽  
Elena Martínez-Rosales ◽  
Alejandro Carretero-Ruiz ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Weight Loss ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Exercise Program ◽  
Extreme Obesity ◽  
Randomized Controlled ◽  
Supervised Exercise ◽  
Parallel Group ◽  
Supervised Exercise Program

Abstract Background Previous studies have investigated weight loss caused by exercise following bariatric surgery. However, in most cases, the training program is poorly reported; the exercise type, volume, and intensity are briefly mentioned; and the sample size, selection criteria, and follow-up time vary greatly across studies. Purpose The EFIBAR study aims to investigate over 1 year the effects of a 16-week supervised exercise program, initiated immediately after bariatric surgery, on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, and quality of life in patients with severe/extreme obesity. Material and Methods The EFIBAR study is a parallel-group, superiority, randomized controlled trial (RCT), comprising 80 surgery patients. Half of the participants, randomly selected, perform a 16-week supervised exercise program, including both strength and aerobic training, starting immediately after the surgery (7–14 days). For each participant, all primary and secondary outcomes are measured at three different time points: (i) before the surgery, (ii) after the intervention (≈4 months), and (iii) 1 year after the surgery. Conclusion The EFIBAR study will provide new insights into the multidimensional benefits of exercise in adults with severe/extreme obesity following bariatric surgery. Trial Registration EFIBAR randomized controlled trial was prospectively registered at Clinicaltrials.gov (NCT03497546) on April 13, 2018. Graphical abstract

scholarly journals Effects of Resistance Exercise and Protein on Body Composition Following Weight Loss

2018 ◽  
Vol 7 (2) ◽  
pp. 25-32
Author(s):  
Wayne Westcott ◽  
Amanda Colligan ◽  
Kelly Lannutti ◽  
Rita La Rosa Loud ◽  
Samantha Vallier
Keyword(s):  
Weight Loss ◽  
Body Composition ◽  
Body Weight ◽  
Fat Mass ◽  
Lean Mass ◽  
Weight Maintenance ◽  
Meal Replacement ◽  
Waist Girth ◽  
Maintenance Program ◽  
Weight Loss Study

Background: Research indicates that weight loss programs are effective for reducing body weight temporarily, but weight maintenance studies have been almost uniformly unsuccessful in preventing weight regain. Methods: Subjects who completed a 6-month weight loss study were invited to continue with a weight maintenance program. The weight loss study examined the effects of exercise (20 min strength, 20 min aerobics, twice weekly) and nutrition (1,200 to 1,800 kcal·d−1, 2 daily meal replacement protein shakes) on body weight and body composition. Weight loss program completers experienced improvements (P &lt; 0.05) in body weight, percent fat, fat mass, lean mass, waist girth, and hip girth. Subjects who participated in the weight maintenance program performed the same strength and aerobic exercise protocol, but discontinued caloric restriction and decreased daily meal replacement protein shakes from 2 to 1. Results: After 6 months on the weight maintenance program, participants experienced improvement (P &lt; 0.05) in percent fat, fat mass, lean mass, waist girth, and hip girth, with no significant change in body weight. A subgroup of subjects who continued the weight maintenance program for an additional 3 months experienced additional improvement (P &lt; 0.05) in percent fat, fat mass, lean mass, waist girth, and hip girth, with no significant change in body weight. Conclusion: These findings indicated that a postdiet weight maintenance program incorporating 2 weekly resistance and aerobic exercise sessions coupled with a daily meal replacement protein shake was effective for avoiding weight regain and for improving body composition, with concurrent fat mass decrease and lean mass increase.

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