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The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study--a randomized controlled trial.

ABSTRACT: Few studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits.The study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n = 61,301), two random sample were drawn (group A, n = 11,708; group B, n = 1,308). Subjects were invited for a health screening program. Participation rate was 52.5%. All participants received individual life-style counselling. Individuals at high risk of ischemic heart disease in group A were furthermore offered group-based life-style counselling. The intervention was repeated for high-risk individuals after one and three years. At five-year follow-up all participants were invited for a health examination. High risk individuals were included in this study (n = 2 356) and changes in dietary intake were analyzed using multilevel linear regression analyses.At one-year follow-up group A had significantly increased the unsaturated/saturated fat ratio compared to group B and in men a significantly greater decrease in saturated fat intake was found in group A compared to group B (net change: -1.13 E%; P = 0.003). No differences were found between group A and B at three-year follow-up. At five-year follow-up group A had significantly increased the unsaturated/saturated fat ratio (net change: 0.09; P = 0.01) and the fish intake compared to group B (net change: 5.4 g/day; P = 0.05). Further, in men a non-significant tendency of a greater decrease was found at five year follow-up in group A compared to group B (net change: -0.68 E%; P = 0.10). The intake of fibre and vegetables increased in both groups, however, no significant difference was found between the groups. No differences between groups were found for saturated fat intake in women.Offering group-based counselling in addition to individual counselling resulted in small, but significantly improved dietary habits at five-year follow-up and a tendency of better maintenance, compared to individual counselling alone.The Inter99 study was approved by the local Ethics Committee (KA 98 155) and is registered with ClinicalTrials.gov (registration number: NCT00289237).

SUBMITTER: Toft U

PROVIDER: S-EPMC2607304 | biostudies-literature | 2008 Nov

REPOSITORIES: biostudies-literature

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The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study--a randomized controlled trial.

Toft Ulla U Kristoffersen Lis L Ladelund Steen S Ovesen Lars L Lau Cathrine C Pisinger Charlotta C Smith Lisa von Huth Lv Borch-Johnsen Knut K Jørgensen Torben T

The international journal of behavioral nutrition and physical activity 20081121

<h4>Background</h4>Few studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits.<h4>Methods</h4>The study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n = 61,301), two random sample were drawn (group A, n = 11,708; g ...[more]

PMID: 19025583

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Project description:ObjectiveTo investigate the effect of systematic screening for risk factors for ischaemic heart disease followed by repeated lifestyle counselling on the 10 year development of ischaemic heart disease at a population level.DesignRandomised controlled community based trial.SettingSuburbs of Copenhagen, Denmark.Participants59,616 people aged 30-60 years randomised with different age and sex randomisation ratios to an intervention group (n = 11,629) and a control group (n = 47,987).InterventionThe intervention group was invited for screening, risk assessment, and lifestyle counselling up to four times over a five year period. All participants with an unhealthy lifestyle had individually tailored lifestyle counselling at all visits (at baseline and after one and three years); those at high risk of ischaemic heart disease, according to predefined criteria, were furthermore offered six sessions of group based lifestyle counselling on smoking cessation, diet, and physical activity. After five years all were invited for a final counselling session. Participants were referred to their general practitioner for medical treatment, if relevant. The control group was not invited for screening.Main outcome measuresThe primary outcome measure was incidence of ischaemic heart disease in the intervention group compared with the control group. Secondary outcome measures were stroke, combined events (ischaemic heart disease, stroke, or both), and mortality.Results6091 (52.4%) people in the intervention group participated at baseline. Among 5978 people eligible at five year follow-up (59 died and 54 emigrated), 4028 (67.4%) attended. A total of 3163 people died in the 10 year follow-up period. Among 58,308 without a history of ischaemic heart disease at baseline, 2782 developed ischaemic heart disease. Among 58,940 without a history of stroke at baseline, 1726 developed stroke. No significant difference was seen between the intervention and control groups in the primary end point (hazard ratio for ischaemic heart disease 1.03, 95% confidence interval 0.94 to 1.13) or in the secondary endpoints (stroke 0.98, 0.87 to 1.11; combined endpoint 1.01, 0.93 to 1.09; total mortality 1.00, 0.91 to 1.09).ConclusionA community based, individually tailored intervention programme with screening for risk of ischaemic heart disease and repeated lifestyle intervention over five years had no effect on ischaemic heart disease, stroke, or mortality at the population level after 10 years.Trial registration Clinical trials NCT00289237.

Project description:BackgroundMulti-factorial intervention studies have been found to be successful in the initiation of lifestyle changes. However, little is known about the longer-term maintenance of health behavior improvements. The purpose of this study was to investigate whether improvements in physical activity and dietary habits achieved in a population-based multi-factorial lifestyle intervention of five years duration were maintained five years after intervention activities have ended.MethodsThe study was a population-based randomized controlled trial, Inter99 (1999-2006), Copenhagen, Denmark. Over five years, all participants in the intervention group (n = 6,091) received individual lifestyle counseling; participants at high risk of ischemic heart disease - according to pre-specified criteria - were also offered group-based counseling. The control group (n = 3,324) was followed by questionnaires. Both groups were followed one, three, five, and ten years after baseline. Changes in physical activity and dietary habits (intake of vegetables, fruit, fish, and saturated fat) during and after the intervention were investigated using random-coefficient models.ResultsFive years after the intervention, women in the intervention group reported greater improvements in the intake of fruit (M Δ = 90.2 g/week, p = 0.041) and less intake of saturated fat (OR = 0.30, 95% CI: 0.17-0.54) than the control group. Men in the intervention group reported greater improvements in physical activity (M Δ = 19.6 min/week, p = 0.003) and less intake of saturated fat (OR = 0.31, 95% CI: 0.17-0.56) than the control group. Improvements in the intake of vegetables and fish achieved during the intervention were not maintained in the longer-term.ConclusionsScreening and lifestyle counseling had sustained effects on physical activity and dietary habits five years after its discontinuation. The patterns of long-term changes in lifestyle differed across behaviors and between men and women.Trial registrationClinicalTrials.gov ( NCT00289237 ).

Project description:BackgroundHypertension is highly prevalent among adults, and is the most important modifiable risk factor for cardiovascular events, in particular stroke. Decreasing sodium intake has the potential to prevent or delay the development of hypertension and improve blood pressure control, independently of blood pressure lowering drugs, among hypertensive patients. Despite guidelines recommending a low sodium diet, especially for hypertensive individuals, sodium intake remains higher than recommended. A recent systematic review indicated that the efficacious counselling methods described in published trials are not suitable for hypertension management by primary care providers in Canada in the present form. The primary reason for the lack of feasibility is that interventions for sodium restriction in these trials was not limited to counselling, but included provision of food, prepared meals, or intensive inpatient training sessions.Methods/designThis is a parallel, randomized, controlled, open-label trial with blinded endpoints. Inclusion criteria are adult patients with hypertension with high dietary sodium intake (defined as ≥ 100 mmol/day). The control arm will receive usual care, and the intervention arm will receive usual care and an additional structured counselling session by a registered dietitian, with four follow-up telephone support sessions over four weeks. The two primary outcomes are change in sodium intake from baseline, as measured by a change in 24-hour urinary sodium measurements at four weeks and one year. Secondary outcomes include change in blood pressure (as measured by 24-hour ambulatory monitoring), change in 24-hour urinary potassium, and change in body weight at the same time points.DiscussionThough decreasing sodium intake has been reported to be efficacious in lowering blood pressure, there exists a gap in the evidence for an effective intervention that could be easily translated into clinical practice. If successful, our intervention would be suitable for outpatient programs such as hypertension clinics or interprofessional family practices (family health teams). A negative, or partially negative (positive effect at four weeks with attrition by 12 months) trial outcome also has significant implications for healthcare delivery and use of resources.Trial registrationThe trial was registered with Clinicaltrials.gov (identifier: NCT02283697) on 2 November 2014.

Project description:BackgroundWhile low sodium intake (<2.3 g/day) is recommended, there is uncertainty about long-term feasibility and effects on cardiorenal biomarkers in populations with moderate intake.MethodsIn two phase IIb, feasibility, randomised, parallel, open-label, controlled, single-centre trials, individuals aged >40 years with stable blood pressure (BP), without heart failure or postural hypotension were randomised to intensive dietary counselling (target sodium intake <2.3 g/day) or usual care between March 2016 and July 2018. One trial included participants with chronic kidney disease (CKD); the other excluded those with CKD or cardiovascular disease. All participants received healthy eating advice. Primary outcomes were NT-pro B-type natriuretic peptide (NT-proBNP), high sensitivity troponin T (hsTnT), C-reactive protein (CRP), renin, aldosterone and, creatinine clearance (CrCl) at 2-years. These trials are registered with ClinicalTrials.gov, STICK trial (NCT02458248) and COSIP trial (NCT02738736).Findings373 participants, with mean 24-h urine sodium 3.16 ± 1.47 g/day, were randomised to intervention (n = 187) or usual care (n = 186). At 3-months, the intervention reduced 24-h urine sodium (intervention -0.11 g/day, usual care +0.28 g/day, p = 0.003), BP (systolic -2.52 mmHg, p = 0.05; diastolic -1.92, p = 0.02) and increased renin (+33.35 mIU/L [95%CI 3.78-62.91]). At 2-years, the intervention significantly reduced self-reported salt use (p < 0.001), but not 24-h urine sodium (intervention -0.23 g/day, usual care +0.05 g/day, p = 0.47). At 2-years, there were no significant between-group differences in BP (systolic p = 0.66; diastolic p = 0.09), NT-proBNP (p = 0.68), hsTnT (p = 0.20), CRP (p = 0.56), renin (p = 0.52), aldosterone (p = 0.61), or CrCl (p = 0.68).InterpretationAmong individuals with moderate sodium intake, intensive dietary counselling resulted in small short-term reductions in sodium intake and BP, but no significant effect on sodium intake, BP, or cardiorenal biomarkers at two years. Our trial suggests that it may not feasible to reduce sodium sustainably in those with a sodium intake around 3.0 g/day, through an intensive dietary counselling intervention.FundingThe STICK trial was funded by the Health Research Board of Ireland and the COSIP trial was funded by the European Research Council.

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The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study--a randomized controlled trial.

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The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study--a randomized controlled trial.

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