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Effectiveness of Written Dietary Advice for Improving Blood Lipids in Primary Care Adults-A Pragmatic Randomized Controlled Trial (MYDICLIN).

ABSTRACT: Lifestyle management is the first line of treatment for moderately elevated blood lipids in healthy individuals. We investigated the effectiveness of providing food-based written advice for lowering low-density lipoprotein (LDL) cholesterol (intervention) or triglycerides (control) in a pragmatic randomized controlled trial with two parallel arms from 2018-2019 at a rural primary health care center. We sent feedback letters after 3 weeks and 6 months. Out of the 113 adult primary care patients randomized, 112 completed the study. There were no differences between the intervention and control groups for changes in LDL cholesterol after 3 weeks (mean ± standard deviation -0.21 ± 0.38 vs. -0.11 ± 0.34 mmol/L, p = 0.45) or 6 months (-0.05 ± 0.47 vs. 0.02 ± 0.41 mmol/L, p = 0.70) (primary outcome). Following the advice to consume plant sterols and turmeric was associated with a reduction in LDL cholesterol after 3 weeks. Following the advice to consume less carbohydrates was associated with reduced triglycerides. In the intervention arm, 14 individuals (25%) reduced their LDL cholesterol by ≥10% after three weeks. Their reduction was attenuated but maintained after six months (-7.1 ± 9.2% or -0.31 ± 0.38 mmol/L, p = 0.01 compared with baseline). They differed only in higher adherence to the advice regarding turmeric. In conclusion, this undemanding intervention had little effect on blood lipids for most individuals.

SUBMITTER: Rydell A

PROVIDER: S-EPMC8912386 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Effectiveness of Written Dietary Advice for Improving Blood Lipids in Primary Care Adults-A Pragmatic Randomized Controlled Trial (MYDICLIN).

Rydell Andreas A Hellsten Mikael M Lindow Martin M Iggman David D

Nutrients 20220228 5

Lifestyle management is the first line of treatment for moderately elevated blood lipids in healthy individuals. We investigated the effectiveness of providing food-based written advice for lowering low-density lipoprotein (LDL) cholesterol (intervention) or triglycerides (control) in a pragmatic randomized controlled trial with two parallel arms from 2018-2019 at a rural primary health care center. We sent feedback letters after 3 weeks and 6 months. Out of the 113 adult primary care patients r ...[more]

PMID: 35267997

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Project description:BackgroundDietary patterns (DPs) in India are heterogenous. To date, data on association of indigenous DPs in India with risk factors of nutrition-related noncommunicable diseases (cardiovascular disease and diabetes), leading causes of premature death and disability, are limited. We aimed to evaluate the associations of empirically-derived DPs with blood lipids, fasting glucose and blood pressure levels in an adult Indian population recruited across four geographical regions of India.MethodsWe used cross-sectional data from the Indian Migration Study (2005-2007). Study participants included urban migrants, their rural siblings and urban residents and their urban siblings from Lucknow, Nagpur, Hyderabad and Bangalore (n = 7067, mean age 40.8 yrs). Information on diet (validated interviewer-administered, 184-item semi-quantitative food frequency questionnaire), tobacco consumption, alcohol intake, physical activity, medical history, as well as anthropometric measurements were collected. Fasting-blood samples were collected for estimation of blood lipids and glucose. Principal component analysis (PCA) was used to identify major DPs based on eigenvalue> 1 and component interpretability. Robust standard error multivariable linear regression models were used to investigate the association of DPs (tertiles) with total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), triglycerides, fasting-blood glucose (FBG), systolic and diastolic blood pressure (SBP and DBP) levels.ResultsThree major DPs were identified: 'cereal-savoury' (cooked grains, rice/rice-based dishes, snacks, condiments, soups, nuts), 'fruit-vegetable-sweets-snacks' (Western cereals, vegetables, fruit, fruit juices, cooked milk products, snacks, sugars, sweets) and 'animal food' (red meat, poultry, fish/seafood, eggs) patterns. High intake of the 'animal food' pattern was positively associated with levels of TC (β = 0.10 mmol/L; 95% CI: 0.02, 0.17 mmol/L; p-trend = 0.013); LDL-C (β = 0.07 mmol/L; 95% CI: 0.004, 0.14 mmol/L; p-trend = 0.041); HDL-C (β = 0.02 mmol/L; 95% CI: 0.004, 0.04 mmol/L; p-trend = 0.016), FBG: (β = 0.09 mmol/L; 95% CI: 0.01, 0.16 mmol/L; p-trend = 0.021) SBP (β = 1.2 mm/Hg; 95% CI: 0.1, 2.3 mm/Hg; p-trend = 0.032); DBP: (β = 0.9 mm/Hg; 95% CI: 0.2, 1.5 mm/Hg; p-trend = 0.013). The 'cereal-savoury' and 'fruit-vegetable-sweets-snacks' patterns showed no association with any parameter except for a positive association with diastolic blood pressure for high intake of 'fruits-vegetables-sweets-snacks' pattern.ConclusionOur results indicate positive associations of the 'animal food' pattern with cardio-metabolic risk factors in India. Further longitudinal assessments of dietary patterns in India are required to validate the findings.

Project description:ObjectivesTo assess the clinical effectiveness, effect on waiting times, and patient acceptability of PhysioDirect services in patients with musculoskeletal problems, compared with usual care.DesignPragmatic randomised controlled trial to assess equivalence in clinical effectiveness. Patients were individually randomised in a 2:1 ratio to PhysioDirect or usual care.SettingFour physiotherapy services in England.ParticipantsAdults (aged ≥ 18 years) referred by general practitioners or self referred for musculoskeletal physiotherapy.InterventionsPhysioDirect services invited patients to telephone a physiotherapist for initial assessment and advice, followed by face-to-face physiotherapy if necessary. Usual care involved patients joining a waiting list for face-to-face treatment.Main outcome measuresNumbers of appointments, waiting time for treatment, and non-attendance rates. Primary outcome was physical health (SF-36v2 physical component score) at six months. Secondary outcomes included four other measures of health outcome, mental component score and scales from the SF-36v2, time lost from work, and patient satisfaction and preference. Participants were not blind to allocation, but outcome data were collected blind to allocation.ResultsOf 1506 patients allocated to PhysioDirect and 743 to usual care, 85% provided primary outcome data at six months (1283 and 629 patients, respectively). PhysioDirect patients had fewer face-to-face appointments than usual care patients (mean 1.91 v 3.11; incidence rate ratio 0.59 (95% confidence interval 0.53 to 0.65)), a shorter waiting time (median 7 days v 34 days; arm time ratio 0.32 (0.29 to 0.35)), and lower rates of non-attendance (incidence rate ratio 0.55 (0.41 to 0.73)). After six months' follow-up, the SF-36v2 physical component score was equivalent between groups (adjusted difference in means -0.01 (-0.80 to 0.79)). Health outcome measures suggested a trend towards slightly greater improvement in the PhysioDirect arm at six week follow-up and no difference at six months. There was no difference in time lost from work. PhysioDirect patients were no more satisfied with access to physiotherapy than usual care patients, but had slightly lower satisfaction overall at six months (difference in satisfaction -3.8% (-7.3% to -0.3%); P=0.031). PhysioDirect patients were more likely than usual care patients to prefer PhysioDirect in future. No adverse events were detected.ConclusionsPhysioDirect is equally clinically effective compared with usual care, provides faster access to physiotherapy, and seems to be safe. However, it could be associated with slightly lower patient satisfaction.Trial registrationCurrent Controlled Trials ISRCTN55666618.

Project description:PurposeTo examine the cost effectiveness of dietary advice to increase protein intake on 6-month change in physical functioning among older adults.MethodsIn this multicenter randomized controlled trial, 276 community-dwelling older adults with a habitual protein intake < 1.0 g/kg adjusted body weight (aBW)/d were randomly assigned to either Intervention 1; advice to increase protein intake to ≥ 1.2 g/kg aBW/d (PROT, n = 96), Intervention 2; similar advice and in addition advice to consume protein (en)rich(ed) foods within half an hour after usual physical activity (PROT + TIMING, n = 89), or continue the habitual diet with no advice (CON, n = 91). Primary outcome was 6-month change in 400-m walk time. Secondary outcomes were 6-month change in physical performance, leg extension strength, grip strength, body composition, self-reported mobility limitations and quality of life. We evaluated cost effectiveness from a societal perspective.ResultsCompared to CON, a positive effect on walk time was observed for PROT; - 12.4 s (95%CI, - 21.8 to - 2.9), and for PROT + TIMING; - 4.9 s (95%CI, - 14.5 to 4.7). Leg extension strength significantly increased in PROT (+ 32.6 N (95%CI, 10.6-54.5)) and PROT + TIMING (+ 24.3 N (95%CI, 0.2-48.5)) compared to CON. No significant intervention effects were observed for the other secondary outcomes. From a societal perspective, PROT was cost effective compared to CON.ConclusionDietary advice to increase protein intake to ≥ 1.2 g/kg aBW/d improved 400-m walk time and leg strength among older adults with a lower habitual protein intake. From a societal perspective, PROT was considered cost-effective compared to CON. These findings support the need for re-evaluating the protein RDA of 0.8 g/kg BW/d for older adults.Trial registrationThe trial has been registered at ClinicalTrials.gov (NCT03712306). Date of registration: October 2018. Registry name: The (Cost) Effectiveness of Increasing Protein Intake on Physical Functioning in Older Adults. Trial Identifier: NCT03712306.

Project description:BackgroundThe chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting.MethodsThis was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c < 6.5%. Secondary outcomes were the change in proportion of patients achieving targets for blood pressure, lipid profile, body mass index and waist circumference. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for baseline differences and clustering effect.ResultsA total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs.Control417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs.Control-4.1%, P < 0.002). Patients who received the EMPOWER-PAR intervention were twice more likely to achieve HbA1c target compared to those in the control group (adjusted OR 2.16, 95% CI 1.34-3.50, P < 0.002). However, there was no significant improvement found in the secondary outcomes.ConclusionsThis study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting.Trial registrationRegistered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.

Dataset Information

Effectiveness of Written Dietary Advice for Improving Blood Lipids in Primary Care Adults-A Pragmatic Randomized Controlled Trial (MYDICLIN).

Publications

Effectiveness of Written Dietary Advice for Improving Blood Lipids in Primary Care Adults-A Pragmatic Randomized Controlled Trial (MYDICLIN).

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