scholarly journals A Pilot Randomized Controlled Trial of a Partial Meal Replacement Preconception Weight Loss Program for Women with Overweight and Obesity

Nutrients ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 3200
Author(s):  
Roslyn Muirhead ◽  
Nathalie Kizirian ◽  
Ravin Lal ◽  
Kirsten Black ◽  
Ann Prys-Davies ◽  
...  
Keyword(s):  
Weight Loss ◽  
Gestational Hypertension ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Overweight And Obesity ◽  
Dietary Advice ◽  
Meal Replacement ◽  
Intention To Treat ◽  
Randomised Controlled ◽  
Meal Replacements

About half of Australian women have a body mass index in the overweight or obese range at the start of pregnancy, with serious consequences including preterm birth, gestational hypertension and diabetes, caesarean section, stillbirth, and childhood obesity. Trials to limit weight gain during pregnancy have had limited success and reducing weight before pregnancy has greater potential to improve outcomes. The PreBabe Pilot study was a randomised controlled pilot trial to assess the feasibility, acceptability and potential weight loss achieved using a commercial online partial meal replacement program, (MR) vs. telephone-based conventional dietary advice, (DA) for pre-conception weight-loss over a 10-week period. Women 18–40 years of age with a BMI ≥ 25 kg/m2 planning pregnancy within the next 6 to 12 months were included in the study. All participants had three clinic visits with a dietitian and one obstetric consultation. In total, 50 women were enrolled in the study between June 2018 and October 2019–26 in MR and 24 in DA. Study retention at the end of 10 week intervention 81% in the MR arm and 75% in the DA arm. In the-intention-to-treat analysis, women using meal replacements lost on average 5.4 ± 3.1% body weight compared to 2.3 ± 4.2% for women receiving conventional advice (p = 0.029). Over 80% of women in the MR arm rated the support received as excellent, compared to 39% in the DA arm (p < 0.001). Women assigned to the MR intervention were more likely to achieve pregnancy within 12 months of the 10 week intervention (57% (12 of 21) women assigned to MR intervention vs. 22% (4 of 18) assigned to the DA group (p = 0.049) became pregnant). The findings suggest that a weight loss intervention using meal replacements in the preconception period was acceptable and may result in greater weight loss than conventional dietary advice alone.

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 Telemedical coaching for weight loss in overweight employees: a three-armed randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e022242 ◽  
Author(s):  
Kerstin Kempf ◽  
Martin Röhling ◽  
Stephan Martin ◽  
Michael Schneider
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Weight Reduction ◽  
Controlled Trial ◽  
Eating Behaviour ◽  
Healthcare Setting ◽  
Intention To Treat ◽  
Link Type ◽  
Randomised Controlled

ObjectivesWe examined the effect of a telemedical coaching (TMC) programme accompanied with or without telemonitoring on weight loss in an occupational healthcare setting with a three-armed randomised controlled trial (NCT01837134’Pre-results').MethodsOverweight employees (n=104, body mass index [BMI] ≥25 kg/m2) were invited by their medical corporate department and randomised into either a TMC group (n=34) or in one of the two control groups (C1, n=34; C2, n=36). TMC and C1 were equipped with telemonitoring devices (scales and pedometers) at baseline, and C2 after 6 months. Telemonitoring devices automatically transferred data into a personalised online portal. TMC was coached with weekly care calls in months 3–6 and monthly calls from months 7 to 12. C2 had a short coaching phase in months 6–9. C1 received no further support. After the 12-month intervention phase, participants could take advantage of further company health promotion offers. Follow-up data were determined after 12 months of intervention and per-protocol (PP) and intention-to-treat (ITT) analyses were performed. Weight change was followed up after 36 months. Estimated treatment difference (ETD) was calculated for weight reduction.ResultsETD from TMC to C1 (−3.6 kg 95% CI −7.40 to −0.1, p=0.047) and to C2 (−4.2 kg [−7.90 to −0.5], p=0.026) was significantly different at the 12 months follow-up in the PP-analysis, but lost significance in the ITT analysis. All groups reduced weight after 12 months (−3.3 to −8.4 kg [5.5–10.3 kg], all p<0.01) and sustained it during the 36 months follow-up (−4.8 to −7.8 kg [5.6–12.8 kg], all p<0.01). ETD analyses revealed no difference between all groups neither in the PP nor in the ITT analysis at the 3 years follow-up. All groups reduced BMI, systolic and diastolic blood pressure and improved eating behaviour in the PP or ITT analyses.ConclusionsTMC and/or telemonitoring support long-term weight reduction in overweight employees. The combination of both interventions points towards an additional effect.Trial registration numberNCT01837134.

scholarly journals Mobile technology intervention for weight loss in rural men: protocol for a pilot pragmatic randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e035089 ◽  
Author(s):  
Christine M Eisenhauer ◽  
Fabiana Almeida Brito ◽  
Aaron M Yoder ◽  
Kevin A Kupzyk ◽  
Carol H Pullen ◽  
...  
Keyword(s):  
Physical Activity ◽  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Mobile Technology ◽  
Vegetable Consumption ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Self Monitoring ◽  
Randomised Controlled ◽  
Monitoring Application

IntroductionMen who are overweight or obese in the rural Midwestern USA are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care and poor lifestyle behaviours that contribute to sedentary lifestyle and unhealthy diet. Self-monitoring of eating and activity has demonstrated efficacy for weight loss. Use of mobile technologies for self-monitoring eating and activity may address rural men’s access disparities to preventive health resources and support weight loss. Our pilot trial will assess the feasibility and acceptability of two mobile applications for weight loss in rural men to inform a future, full-scale trial.Methods and analysisA 6-month randomised controlled trial with contextual evaluation will randomise 80 men using a 1:1 ratio to either a Mobile Technology Plus (MT+) intervention or a basic Mobile Technology (MT) intervention in rural, midlife men (aged 40–69 years). The MT+ intervention consists of a smartphone self-monitoring application enhanced with discussion group (Lose-It premium), short message service text-based support and Wi-Fi scale. The MT group will receive only a self-monitoring application (Lose-It basic). Feasibility and acceptability will be evaluated using number of men recruited and retained, and evaluative focus group feedback. We seek to determine point estimates and variability of outcome measures of weight loss (kg and % body weight) and improved dietary and physical activity behaviours (Behavioral Risk Factor Surveillance System (BRFSS) physical activity and fruit and vegetable consumption surveys, data from Lose-It! application (kcal/day, steps/day)). Community capacity will be assessed using standard best practice methods. Descriptive content analysis will evaluate intervention acceptability and contextual sensitivity.Ethics and disseminationThis protocol was approved by the University of Nebraska Medical Center Institutional Review Board (IRB# 594–17-EP). Dissemination of findings will occur through ClinicalTrials.gov and publish pilot data to inform the design of a larger clinical trial.Trial registration numberNCT03329079; preresults. Protocol V.10, study completion date 31 August 2020. Roles and responsibilities funder: NIH/NINR Health Disparities Section 1R15NR017522-01.

scholarly journals Structured, multifactorial randomised controlled intervention to investigate physical activity levels, body composition and diet in obese and overweight adolescents

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044895
Author(s):  
Prateek Srivastav ◽  
Vaishali K ◽  
Vinod H Bhat ◽  
Suzanne Broadbent
Keyword(s):  
Physical Activity ◽  
Body Composition ◽  
Controlled Trial ◽  
Overweight And Obesity ◽  
Dietary Advice ◽  
Activity Levels ◽  
Registration Number ◽  
Family Based ◽  
Group B ◽  
Randomised Controlled

IntroductionThere has been a steep increase in the prevalence of adolescent overweight and obesity globally and in India, demonstrating that present prevention strategies are insufficient. Available evidence suggests that multifactorial interventions may improve short-term physical activity (PA), nutrition and psychological behaviour of overweight and obese adolescents but long-term follow-ups and strategies are needed. This study will investigate the effects of a structured multifactorial (school-based and family-based) intervention on adolescent obesity, compared with a single or no intervention.Methods and analysisA pragmatic, clustered randomised controlled trial with 12 weeks of interventions and 3-month, 6-month and 12-month follow-ups will be conducted at multiple participating schools in Karnataka, India. The participants will be overweight and obese male and female adolescents aged 11–16 years and will be randomly assigned by school into three groups: group A (multifactorial intervention, exercise and dietary advice); group B (exercise only); and group C (controls, no interventions). Primary outcome measures are the level of PA and body composition. Secondary outcomes are dietary change, behaviour change, food behaviours, cardiovascular and muscular fitness, quality of life, parental behaviours (physical and mental) and family functioning. Positive intervention results may reduce obesity in adolescents and promote a healthier lifestyle for students and families. A larger, culturally diverse population can benefit from a similar methodology.Ethics and disseminationThe study has been approved by the Institutional Research and Ethics Committee (IEC 536-2018), Kasturba Hospital, Manipal, Udupi District, Karnataka, India. A written and verbal informed consent (supplemental material) will be provided to the participants prior to participation. On completion of the trial, the results can be communicated to adolescents and their parents on request, and will be published at national and international conferences and in peer-reviewed journals.Trial registration numberCTRI/2019/04/018834.

scholarly journals The effects of time-restricted eating vs. standard dietary advice on weight, metabolic health and the consumption of processed food: A pragmatic randomised controlled trial in community-based adults

2021 ◽  
Author(s):  
Nicholas Edward Phillips ◽  
Julie Mareschal ◽  
Nathalie Schwab ◽  
Emily N.C. Manoogian ◽  
Sylvie Borloz ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Metabolic Health ◽  
Dietary Advice ◽  
Individual Response ◽  
Processed Food ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

AbstractThe prevalence of metabolic syndrome (MS) is increasing, affecting approximately 1 billion people. Weight loss is key to control MS components, i.e. central obesity, hypertension, prediabetes, and dyslipidaemia. Here, we characterised the relationships between eating duration, unprocessed and processed food consumption, and metabolic health. In a 4-week observation phase, 213 Swiss adults recorded consumed meals and drinks with a smartphone application, and these were annotated for food processing levels according to the NOVA classification. Regression analysis showed that consumption of unprocessed food items showed the highest number of significant relationships with MS components after age and sex. The fraction of unprocessed food out of all ingestion events was positively associated with HDL cholesterol and negatively associated with BMI, waist circumference and triglycerides. Next, in a pragmatic randomised controlled trial, we tested whether 12h time-restricted eating (TRE) leads to metabolic benefits compared to standard dietary advice (SDA), in 54 adults who ate >14h per 24h cycle and had 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). Thus, there was no significant difference in weight loss between TRE and SDA (between-group difference −0.5 kg, 95% confidence interval −2.4 to 1.4, p = 0.61). Overall, our results show the potential of smartphone records to predict metabolic health, and highlight that further research is needed to understand individual response to TRE and SDA.

scholarly journals T44. 12-MONTH FOLLOW UP OF METABOLIC MEASURES FOLLOWING A RANDOMISED CONTROLLED TRIAL OF TREATMENT OF CLOZAPINE ASSOCIATED OBESITY AND DIABETES WITH EXENATIDE (CODEX)

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S248-S248
Author(s):  
Dan Siskind ◽  
Anthony Russell ◽  
Steve Kisely
Keyword(s):  
Weight Loss ◽  
Fasting Glucose ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Glycated Haemoglobin ◽  
Open Label ◽  
Treatment As Usual ◽  
Obesity And Diabetes ◽  
Randomised Controlled

Abstract Background Clozapine is associated with high rates of obesity and type 2 diabetes (T2DM). Exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, can counter clozapine-associated GLP-1 dysregulation. Our randomized, controlled (RCT), open-label, pilot trial of once-weekly extended-release subcutaneous exenatide or treatment as usual (TAU) for 24 weeks (n=28), found 6/14 people on exenatide achieved &gt;5% weight loss vs 1/14 receiving usual care (P = .029). Compared with TAU, participants on exenatide had greater mean weight loss body mass index (BMI) reduction, and reduced fasting glucose and glycated haemoglobin (HbA1c) levels. Methods We followed up CODEX trial participants at 12 months following the end of the trial. We collected information on weight, BMI, waist circumference, blood pressure, fasting glucose, HbA1c, and use of metformin. The primary outcome of interest was change in weight. Change in these parameters from trial baseline to 12 months post endpoint and trial endpoint to 12 months post endpoint was compared between those formerly in the exenatide and TAU arms. Results There were no significant differences between baseline and 12-months post endpoint for any of the variables. Data from endpoint to 12-month follow up point showed significantly greater increases among the former exenatide group compared to the former TAU group for weight, BMI, and proportion with &gt;5% weight gain. Stratifying the dataset by whether participants were on metformin six months after the end of the trial did not alter the overall results. Discussion There were significant increases in weight and BMI in the 12 months post endpoint for the former exenatide group, however there were no significant differences in weight and BMI between baseline and 12-month post endpoint. This is in keeping with other GLP-1RA studies. This information suggests the need for continued use of exenatide among people on clozapine who have achieved weight loss.

scholarly journals Does hair curl variation influence the efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia in breast cancer patients? A randomised pilot trial

2021 ◽  
Vol 5 ◽  
Author(s):  
Odirile Obuseng ◽  
Nonhlanhla Khumalo ◽  
Thurandrie Naiker ◽  
Tselane Thebe
Keyword(s):  
Controlled Trial ◽  
Pilot Trial ◽  
Scalp Cooling ◽  
Breast Cancer Patients ◽  
Intention To Treat ◽  
Number Of Patients ◽  
Curly Hair ◽  
Randomised Controlled ◽  
And Control ◽  
To Receive

Background: Scalp cooling is reported to reduce Chemotherapy-induced alopecia (CIA).Aim: To compare the efficacy of scalp cooling for straight versus curly hair in a pilot trail.Setting: A radiation oncology breast cancel clinic.Methods: This 20-month randomised controlled trial recruited females (18–65 years) to receive chemotherapy (Adriamycin or Epirubicin and Cyclophosphamide followed by Paclitaxel) with or without scalp cooling. Outcomes were percentage alopecia (Severity ALopecia Tool) by hair curvature and treatment retention.Results: Forty eight patients (24 per group) were randomised; four in each group withdrew before first study visit and photographs of three in the cooling group could not be found for assessment. Thus 77% constituted the intention-to-treat population (17 cooling vs. 20 control). Agreement on alopecia severity was good overall (intra-class correlation coefficient [ICC] = 0.94; 95% confidence interval [CI]: 0.85–0.97) and at six of seven time points. Overall, cooling significantly reduced CIA, relative to no-cooling (58.15 ± 28.46 vs. 37.29 ± 20.52; p = 0.0167); however, percentage alopecia was cosmetically significant. There was no difference in CIA between cooling participants with straight (n = 8) versus curly hair (n = 9), (p = 0.0740).The number of patients completing the various cycles of chemotherapy declined from 77.1% at cycle 1 to 18.8% at cycle 7 for the whole study, and from 100% each to 17.6% and 30.0% for cooling and control groups, respectively (p = 0.451).Conclusion: This study suggests that hair curvature has no significant impact on the efficacy of scalp cooling to reduce CIA, however, this requires confirmation.

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