scholarly journals Long-Term Effect of Interactive Online Dietician Weight Loss Advice in General Practice (LIVA) Protocol for a Randomized Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Carl J. Brandt ◽  
Vibeke Brandt ◽  
Mathilde Pedersen ◽  
Dorte Glintborg ◽  
Søren Toubro ◽  
...  
Keyword(s):  
Weight Loss ◽  
General Practice ◽  
Large Scale ◽  
Controlled Trial ◽  
Complex Interventions ◽  
Control Group ◽  
Average Weight ◽  
Practice Setting ◽  
Management Support ◽  
General Practice Setting

Background. Internet-based complex interventions aiming to promote weight loss and optimize healthy behaviors have attracted much attention. However, evidence for effect is lacking. Obesity is a growing problem, resulting in an increasing demand for cost efficient weight loss programs suitable for use on a large scale, for example, as part of standard primary care. In a previous pilot project by Brandt et al. (2011) without a control group, we examined the effects of online dietician counseling and found an average weight loss of 7.0 kg (95% CI: 4.6 to 9.3 kg) after 20 months. Aims and Methods. To analyze the effects of a complex intervention using trained dieticians in a general practice setting combined with internet-based interactive and personalized weight management support compared with conventional advice with a noninteractive internet support as placebo treatment in 340 overweight patients during a 2-year period. Primary endpoints are weight loss and lowering of cholesterol (LDL). We will also explore patients’ sociodemographics and use of the intervention as well as the health professionals’ views and perceptions of the intervention (their role and the advice and support that they provide). Perspective. The project will generate knowledge on the cost-effectiveness of a complex internet-based intervention in a general practice setting and on barriers and acceptability among professionals and patients.

scholarly journals Sustained Weight Loss and Improvements in Cardiometabolic Risk Factors in a Worksite-based Behavioral Program (FS18-04-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Sai Krupa Das ◽  
Taylor Vail ◽  
Rachel Silver ◽  
Meghan Chin ◽  
Caroline Blanchard ◽  
...  
Keyword(s):  
Risk Factors ◽  
Weight Loss ◽  
Body Fat ◽  
Cardiometabolic Risk ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cardiometabolic Risk Factors ◽  
Control Group ◽  
Average Weight ◽  
Funding Sources

Abstract Objectives To evaluate the effectiveness of a novel low-burden behavioral intervention (BI) for weight loss on changes in body weight and cardiometabolic risk factors when implemented with or without meal replacements (MR). Methods Twelve worksites (≥300 employees each) in the Greater Boston area participated in a cluster-randomized controlled trial, with 8 worksites (n = 259 participants) allocated to the intervention group (IG) and 4 worksites (n = 76) to a wait-listed control group (CG). IG participants were further randomized to receive the BI, which emphasizes hunger and craving management via diet composition, for 18 months without or with MR (BI + MR). Weight and cardiometabolic variables were measured at baseline and 6 months for all groups, and also at 12 and 18 months in the IGs. Linear mixed models compared 6-month changes in % weight loss, body mass index (BMI), body fat, and cardiometabolic risk factors for all groups. Similar analyses were conducted for the BI and BI + MR groups at 12 and 18 months. Estimated means and standard deviations were calculated. Statistical models were adjusted for age, sex, baseline measurement, and worksite. Results The study population was 83% female. The Mean ± SD for age and BMI were 47.9 ± 10.4 years and 32.9 ± 5.5 kg/m2, respectively. At 6 months, average weight loss was 9.2 ± 7.2% for BI and 8.3 ± 7.0% for BI + MR. Weight loss was significantly greater in both IGs than the CG (both P < 0.001), but not significant between IGs (P = 0.35). Similar results were observed for BMI and % body fat (both P < 0.01). BI and BI + MR had significant reductions in glucose and triglycerides (P < 0.05) compared to the CG. Changes in total cholesterol and LDL were significantly greater in BI + MR compared to BI alone (P < 0.05). Clinically significant reductions in weight and cardiometabolic risk factors were sustained in the IGs at 12 and 18 months. Conclusions To our knowledge, weight loss in this study was greater than previous scalable worksite-based interventions. Weight loss did not significantly differ between the BI and BI + MR groups, and MR use was associated with additional reductions in total and LDL cholesterol. These results demonstrate the feasibility of novel approaches to achieve clinically impactful weight management in worksite settings. Funding Sources Nutrient Foods LLC.

Efficacy of a web-based adaptation of the Diabetes Prevention Program with online nutritional counselling for weight loss during the holiday season among adults with overweight or obesity: a pilot randomised controlled trial (Preprint)

2020 ◽  
Author(s):  
Alma L Ruelas ◽  
Michelle M Haby ◽  
Teresita De Jesús Martinez-Contreras ◽  
Julian Esparza-Romero ◽  
Maria Del Carmen Candia-Plata ◽  
...  
Keyword(s):  
Weight Loss ◽  
Weight Gain ◽  
Controlled Trial ◽  
Diabetes Prevention Program ◽  
Waiting List ◽  
Control Group ◽  
Average Weight ◽  
Web Based ◽  
Holiday Season ◽  
Overweight Or Obesity

BACKGROUND The holiday season is considered a high-risk period for weight gain, especially for people with overweight or obesity. However, few evaluated interventions have focused on preventing weight gain during this period and, to our knowledge, none have intended to treat obesity. OBJECTIVE To evaluate the efficacy of a web-based intervention adapted from the Diabetes Prevention Program (DPP-web) for weight loss in Mexican adults with overweight or obesity at 3 months compared to a waiting list control group. METHODS A pilot randomised controlled trial with parallel groups (DPP-web and waiting list) targeting adults with overweight or obesity. Participants were recruited using Facebook ads. A web-based app was designed for the delivery of the Cognitive Behavioural Sessions (CBS) of the DPP-web, and Facebook video calls were used for weekly online nutrition counselling sessions (NCS) by a trained dietitian. The primary outcome was the change in body weight at 3 months. The secondary outcomes were the changes in other anthropometric variables, systolic and diastolic blood pressure, depression score and health-related quality of life scores at 3 months. All measurements were conducted in a university clinic by the same technician, who was blinded to group allocation. The study was conducted between 24 September 2018 and 20 January 2019, which allowed the evaluation of the effect of the program during the holiday season. RESULTS A total of 30 participants aged 35.2 (SD 10.9) years and with a mean BMI of 33.8 (SD 5.58) kg/m2 were randomized (15 DPP-web, 15 waiting list). A retention rate of 80% was observed at 3 months (12 DPP-web, 12 waiting list). All 30 participants who started the intervention were included in the intention to treat analysis. An average weight loss of 1.57 (SD 3.54) kg was observed in the DPP-web group, compared to an average weight gain of 2.18 (SD 4.22) kg in the control group (P=.01). The estimated difference between groups at 3 months was 3.75 kg (95% CI 0.84, 6.67). CONCLUSIONS The DPP-web supported with online nutrition counselling has a significant effect on body weight, specifically preventing weight gain in adults with overweight or obesity during the holiday season. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT03629301.

scholarly journals The effectiveness of nurse-led self-management support program for people with chronic kidney disease stage 3-4 (CKD-NLSM): Study protocol for a randomized controlled trial

2021 ◽  
Vol 104 (2) ◽  
pp. 003685042110261
Author(s):  
Al Sawad Ayat Ali ◽  
Soo Kun Lim ◽  
Li Yoong Tang ◽  
Aneesa Abdul Rashid ◽  
Boon-How Chew
Keyword(s):  
Kidney Disease ◽  
Controlled Trial ◽  
Self Management ◽  
Control Group ◽  
Management Support ◽  
Disease Knowledge ◽  
Management Intervention ◽  
Randomized Controlled ◽  
Ckd Stage ◽  
Management Behaviors

The complexity of chronic kidney disease (CKD) and its treatments have made self-management behaviors inevitably challenging. However, supplementing education with self-management skills may improve numerous health outcomes in people with nondialysis CKD. This study protocol describes a randomized controlled trial (RCT) aimed to evaluate the effects of a nurse-led self-management support program as an intervention for kidney disease knowledge and CKD self-management behaviors among people with pre-dialysis CKD. In Phase 1, people with CKD stage 3–4 and their family members are involved in co-designing, development and pilot testing of a theory-based self-management intervention. In Phase 2, we perform a cross-cultural adaptation of the Kidney Disease Knowledge Survey, CKD Self-Management and Self-efficacy for Managing Chronic Disease questionnaires. In Phase 3, a parallel RCT will be conducted to evaluate the intervention where 154 participants with CKD stage 3–4 will be randomly assigned to either the intervention ( n = 77) or control group ( n = 77). The intervention group will receive 6-week self-management program from a nurse-coach in addition to standard usual care, while the control group will receive only standard usual care. Outcome measures include kidney disease knowledge, CKD self-management behavior, self-efficacy, quality of life, blood pressure control and adherence to CKD diet as indicated by 24-h urine urea nitrogen, 24-h urine sodium and net endogenous acid production. Data will be collected at baseline and 12-week post-baseline. The between- and within-group intervention effects will be estimated using the Generalized Estimating Equations. The self-management intervention offers strategies to delay CKD progression and to encourage motivation to better self-manage at home. This study integrates self-management education and psychosocial support with culturally relevant scenarios, and evaluates important self-reported and objective outcomes. Clinical Trials Registration: www.ClinicalTrials.gov , identifier: NCT03974646.

Statistical methods for unidirectional switch designs: Past, present, and future

2017 ◽  
Vol 27 (9) ◽  
pp. 2872-2882 ◽  
Author(s):  
Zhuozhao Zhan ◽  
Geertruida H de Bock ◽  
Edwin R van den Heuvel
Keyword(s):  
Statistical Methods ◽  
Large Scale ◽  
Sample Size Calculation ◽  
Complex Interventions ◽  
New Drugs ◽  
Control Treatment ◽  
Future Research ◽  
Control Group ◽  
Unified Framework ◽  
New Treatment

Clinical trials may apply or use a sequential introduction of a new treatment to determine its efficacy or effectiveness with respect to a control treatment. The reasons for choosing a particular switch design have different origins. For instance, they may be implemented for ethical or logistic reasons or for studying disease-modifying effects. Large-scale pragmatic trials with complex interventions often use stepped wedge designs (SWDs), where all participants start at the control group, and during the trial, the control treatment is switched to the new intervention at different moments. They typically use cross-sectional data and cluster randomization. On the other hand, new drugs for inhibition of cognitive decline in Alzheimer’s or Parkinson’s disease typically use delayed start designs (DSDs). Here, participants start in a parallel group design and at a certain moment in the trial, (part of) the control group switches to the new treatment. The studies are longitudinal in nature, and individuals are being randomized. Statistical methods for these unidirectional switch designs (USD) are quite complex and incomparable, and they have been developed by various authors under different terminologies, model specifications, and assumptions. This imposes unnecessary barriers for researchers to compare results or choose the most appropriate method for their own needs. This paper provides an overview of past and current statistical developments for the USDs (SWD and DSD). All designs are formulated in a unified framework of treatment patterns to make comparisons between switch designs easier. The focus is primarily on statistical models, methods of estimation, sample size calculation, and optimal designs for estimation of the treatment effect. Other relevant open issues are being discussed as well to provide suggestions for future research in USDs.

Acquisition of basic clinical skills in the general practice setting

1997 ◽  
Vol 31 (2) ◽  
pp. 99-104 ◽  
Author(s):  
J V Parle ◽  
S M Greenfield ◽  
J Skelton ◽  
H Lester ◽  
F D R Hobbs
Keyword(s):  
General Practice ◽  
Clinical Skills ◽  
Practice Setting ◽  
General Practice Setting
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