scholarly journals Evaluation of an intervention to provide brief support and personalized feedback on food shopping to reduce saturated fat intake (PC-SHOP): A randomized controlled trial

PLoS Medicine ◽  
2020 ◽  
Vol 17 (11) ◽  
pp. e1003385
Author(s):  
Carmen Piernas ◽  
Paul Aveyard ◽  
Charlotte Lee ◽  
Melina Tsiountsioura ◽  
Michaela Noreik ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Primary Care ◽  
Ldl Cholesterol ◽  
Controlled Trial ◽  
Saturated Fat ◽  
Personalized Feedback ◽  
Randomized Controlled ◽  
Brief Advice ◽  
Loyalty Card

Background Guidelines recommend reducing saturated fat (SFA) intake to decrease cardiovascular disease (CVD) risk, but there is limited evidence on scalable and effective approaches to change dietary intake, given the large proportion of the population exceeding SFA recommendations. We aimed to develop a system to provide monthly personalized feedback and healthier swaps based on nutritional analysis of loyalty card data from the largest United Kingdom grocery store together with brief advice and support from a healthcare professional (HCP) in the primary care practice. Following a hybrid effectiveness-feasibility design, we tested the effects of the intervention on SFA intake and low-density lipoprotein (LDL) cholesterol as well as the feasibility and acceptability of providing nutritional advice using loyalty card data. Methods and findings The Primary Care Shopping Intervention for Cardiovascular Disease Prevention (PC-SHOP) study is a parallel randomized controlled trial with a 3 month follow-up conducted between 21 March 2018 to 16 January2019. Adults ≥18 years with LDL cholesterol >3 mmol/L (n = 113) were recruited from general practitioner (GP) practices in Oxfordshire and randomly allocated to “Brief Support” (BS, n = 48), “Brief Support + Shopping Feedback” (SF, n = 48) or “Control” (n = 17). BS consisted of a 10-minute consultation with an HCP to motivate participants to reduce their SFA intake. Shopping feedback comprised a personalized report on the SFA content of grocery purchases and suggestions for lower SFA swaps. The primary outcome was the between-group difference in change in SFA intake (% total energy intake) at 3 months adjusted for baseline SFA and GP practice using intention-to-treat analysis. Secondary outcomes included %SFA in purchases, LDL cholesterol, and feasibility outcomes. The trial was powered to detect an absolute reduction in SFA of 3% (SD3). Neither participants nor the study team were blinded to group allocation. A total of 106 (94%) participants completed the study: 68% women, 95% white ethnicity, average age 62.4 years (SD 10.8), body mass index (BMI) 27.1 kg/m2 (SD 4.7). There were small decreases in SFA intake at 3 months: control = −0.1% (95% CI −1.8 to 1.7), BS = −0.7% (95% CI −1.8 to 0.3), SF = −0.9% (95% CI −2.0 to 0.2); but no evidence of a significant effect of either intervention compared with control (difference adjusted for GP practice and baseline: BS versus control = −0.33% [95% CI −2.11 to 1.44], p = 0.709; SF versus control = −0.11% [95% CI −1.92 to 1.69], p = 0.901). There were similar trends in %SFA based on supermarket purchases: control = −0.5% (95% CI −2.3 to 1.2), BS = −1.3% (95% CI −2.3 to −0.3), SF = −1.5% (95% CI −2.5 to −0.5) from baseline to follow-up, but these were not significantly different: BS versus control p = 0.379; SF versus control p = 0.411. There were small reductions in LDL from baseline to follow-up (control = −0.14 mmol/L [95% CI −0.48, 0.19), BS: −0.39 mmol/L [95% CI −0.59, −0.19], SF: −0.14 mmol/L [95% CI −0.34, 0.07]), but these were not significantly different: BS versus control p = 0.338; SF versus control p = 0.790. Limitations of this study include the small sample of participants recruited, which limits the power to detect smaller differences, and the low response rate (3%), which may limit the generalisability of these findings. Conclusions In this study, we have shown it is feasible to deliver brief advice in primary care to encourage reductions in SFA intake and to provide personalized advice to encourage healthier choices using supermarket loyalty card data. There was no evidence of large reductions in SFA, but we are unable to exclude more modest benefits. The feasibility, acceptability, and scalability of these interventions suggest they have potential to encourage small changes in diet, which could be beneficial at the population level. Trial registration ISRCTN14279335.

scholarly journals Endothelial Dysfunction, Atherosclerosis, and Increase of von Willebrand Factor and Factor VIII: A Randomized Controlled Trial in Swine

2021 ◽  
Author(s):  
Ferdows Atiq ◽  
Jens van de Wouw ◽  
Oana Sorop ◽  
Ilkka Heinonen ◽  
Moniek P. M. de Maat ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Endothelial Dysfunction ◽  
Controlled Trial ◽  
Short Term ◽  
Randomized Controlled ◽  
Von Willebrand ◽  
Willebrand Factor

AbstractIt is well known that high von Willebrand factor (VWF) and factor VIII (FVIII) levels are associated with an increased risk of cardiovascular disease. It is still debated whether VWF and FVIII are biomarkers of endothelial dysfunction and atherosclerosis or whether they have a direct causative role. Therefore, we aimed to unravel the pathophysiological pathways of increased VWF and FVIII levels associated with cardiovascular risk factors. First, we performed a randomized controlled trial in 34 Göttingen miniswine. Diabetes mellitus (DM) was induced with streptozotocin and hypercholesterolemia (HC) via a high-fat diet in 18 swine (DM + HC), while 16 healthy swine served as controls. After 5 months of follow-up, FVIII activity (FVIII:C) was significantly higher in DM + HC swine (5.85 IU/mL [5.00–6.81]) compared with controls (4.57 [3.76–5.40], p = 0.010), whereas VWF antigen (VWF:Ag) was similar (respectively 0.34 IU/mL [0.28–0.39] vs. 0.34 [0.31–0.38], p = 0.644). DM + HC swine had no endothelial dysfunction or atherosclerosis during this short-term follow-up. Subsequently, we performed a long-term (15 months) longitudinal cohort study in 10 Landrace–Yorkshire swine, in five of which HC and in five combined DM + HC were induced. VWF:Ag was higher at 15 months compared with 9 months in HC (0.37 [0.32–0.42] vs. 0.27 [0.23–0.40], p = 0.042) and DM + HC (0.33 [0.32–0.37] vs. 0.25 [0.24–0.33], p = 0.042). Both long-term groups had endothelial dysfunction compared with controls and atherosclerosis after 15 months. In conclusion, short-term hyperglycemia and dyslipidemia increase FVIII, independent of VWF. Long-term DM and HC increase VWF via endothelial dysfunction and atherosclerosis. Therefore, VWF seems to be a biomarker for advanced cardiovascular disease.

scholarly journals Effectiveness of Village Health Worker–Delivered Smoking Cessation Counseling in Vietnam

2018 ◽  
Vol 21 (11) ◽  
pp. 1524-1530 ◽  
Author(s):  
Nan Jiang ◽  
Nina Siman ◽  
Charles M Cleland ◽  
Nancy Van Devanter ◽  
Trang Nguyen ◽  
...  
Keyword(s):  
Primary Care ◽  
Health Care ◽  
Controlled Trial ◽  
Evidence Based ◽  
Care Providers ◽  
Water Pipe ◽  
Randomized Controlled ◽  
Provider Advice ◽  
Village Health

Abstract Introduction Smoking prevalence is high in Vietnam, yet tobacco dependence treatment (TDT) is not widely available. Methods We conducted a quasiexperimental study that compared the effectiveness of health care provider advice and assistance (ARM 1) versus ARM 1 plus village health worker (VHW) counseling (ARM 2) on abstinence at 6-month follow-up. This study was embedded in a larger two-arm cluster randomized controlled trial conducted in 26 community health centers (CHCs) in Vietnam. Subjects (N = 1318) were adult patients who visited any participating CHC during the parent randomized controlled trial intervention period and were self-identified as current tobacco users (cigarettes and/or water pipe). Results At 6-month follow-up, abstinences rates in ARM 2 were significantly higher than those in ARM 1 (25.7% vs. 10.5%; p < .001). In multivariate analyses, smokers in ARM 2 were almost three times more likely to quit compared with those in ARM 1 (adjusted odds ratio [AOR] = 2.96, 95% confidence interval [CI] = 1.78% to 4.92%). Compared to cigarette-only smokers, water pipe–only smokers (AOR = 0.4, 95% CI = 0.26% to 0.62%) and dual users (AOR = 0.62, 95% CI = 0.45% to 0.86%) were less likely to achieve abstinence; however, the addition of VHW counseling (ARM 2) was associated with higher quit rates compared with ARM 1 alone for all smoker types. Conclusion A team approach in TDT programs that offer a referral system for health care providers to refer smokers to VHW-led cessation counseling is a promising and potentially scalable model for increasing access to evidence-based TDT and increasing quit rates in low middle-income countries (LMICs). TDT programs may need to adapt interventions to improve outcomes for water pipe users. Implications The study fills literature gaps on effective models for TDT in LMICs. The addition of VHW-led cessation counseling, available through a referral from primary care providers in CHCs in Vietnam, to health care provider’s brief cessation advice, increased 6-month biochemically validated abstinence rates compared to provider advice alone. The study also demonstrated the potential effectiveness of VHW counseling on reducing water pipe use. For LMICs, TDT programs in primary care settings with a referral system to VHW-led cessation counseling might be a promising and potentially scalable model for increasing access to evidence-based treatment.

scholarly journals A Mobile Health Salt Reduction Intervention for People With Hypertension: Results of a Feasibility Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Sarah Payne Riches ◽  
Carmen Piernas ◽  
Paul Aveyard ◽  
James P Sheppard ◽  
Mike Rayner ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Salt Intake ◽  
Controlled Trial ◽  
Salt Content ◽  
Salt Reduction ◽  
Randomized Controlled ◽  
Secondary Outcomes

BACKGROUND A high-salt diet is a risk factor for hypertension and cardiovascular disease; therefore, reducing dietary salt intake is a key part of prevention strategies. There are few effective salt reduction interventions suitable for delivery in the primary care setting, where the majority of the management and diagnosis of hypertension occurs. OBJECTIVE The aim of this study is to assess the feasibility of a complex behavioral intervention to lower salt intake in people with elevated blood pressure and test the trial procedures for a randomized controlled trial to investigate the intervention’s effectiveness. METHODS This feasibility study was an unblinded, randomized controlled trial of a mobile health intervention for salt reduction versus an advice leaflet (control). The intervention was developed using the Behavior Change Wheel and comprised individualized, brief advice from a health care professional with the use of the SaltSwap app. Participants with an elevated blood pressure recorded in the clinic were recruited through primary care practices in the United Kingdom. Primary outcomes assessed the feasibility of progression to a larger trial, including follow-up attendance, fidelity of intervention delivery, and app use. Secondary outcomes were objectively assessed using changes in salt intake (measured via 24-hour urine collection), salt content of purchased foods, and blood pressure. Qualitative outcomes were assessed using the think-aloud method, and the process outcomes were evaluated. RESULTS A total of 47 participants were randomized. All progression criteria were met: follow-up attendance (45/47, 96%), intervention fidelity (25/31, 81%), and app use (27/31, 87%). There was no evidence that the intervention significantly reduced the salt content of purchased foods, salt intake, or blood pressure; however, this feasibility study was not powered to detect changes in secondary outcomes. Process and qualitative outcomes demonstrated that the trial design was feasible and the intervention was acceptable to both individuals and practitioners and positively influenced salt intake behaviors. CONCLUSIONS The intervention was acceptable and feasible to deliver within primary care; the trial procedures were practicable, and there was sufficient signal of potential efficacy to change salt intake. With some improvements to the intervention app, a larger trial to assess intervention effectiveness for reducing salt intake and blood pressure is warranted. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 20910962; https://www.isrctn.com/ISRCTN20910962

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