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PubMed2006

Assessing the impact of training on mental health nurses' therapeutic attitudes and knowledge about co-morbidity: a randomised controlled trial.

BACKGROUND: Substance misuse can trigger or be causally associated with mental health problems. Therapeutic attitude is important in predicting effective engagement with people with alcohol and drug problems but health professionals' attitudes towards this client group are often negative. Education regarding substance misuse has often been neglected and nurses may lack knowledge to provide appropriate care. OBJECTIVES: To test the impact of training for staff who work with people who have co-existing mental health and substance use problems. DESIGN: A randomised controlled trial. SETTING: An NHS Primary Care Division in the West of Scotland. PARTICIPANTS: Forty-nine mental health nurses. METHODS: Intervention. A four-day training programme. MEASUREMENTS: (a) therapeutic attitudes measured by the co-morbidity problems perceptions questionnaire; (b) knowledge of alcohol, drugs and co-morbidity measured by a structured questionnaire. RESULTS: Significant effects for group (F=30.42, p<0.001) were found in therapeutic attitude scores and also over time (F=10.66, p<0.001). A significant interaction was also found (p<0.001). Post-hoc testing revealed that the mean pre-training attitude score was significantly different from post-training (p=0.001; 95% CI 5.53, 25.38) and from six-months follow-up (p<0.001; 95% CI 11.26, 32.49) but that post-training and follow-up mean scores were not significantly different (p=0.358; 95% CI -4.71, 17.55). For knowledge, a significant group effect was found (F=10.32, p=0.002), and also a significant time effect (F=3.35, p=0.039) but no significant interaction effect was present (p=0.169). The post-hoc testing revealed that only a pre-training to six-month follow-up time effect was statistically significant (p=0.005; 95% CI 1.37, 9.29). CONCLUSIONS: The training programme was effective in improving the therapeutic attitudes of participants to working with clients who have co-existing mental health and substance use problems, both immediately after the training was delivered, and at six-months follow-up. It was also effective in improving participants' overall knowledge of alcohol, drugs and co-morbidity.

Analysis of Variance↗

PubMed1999

Inhaled nitric oxide in premature neonates with severe hypoxaemic respiratory failure: a randomised controlled trial.

BACKGROUND: Inhaled nitric oxide improves oxygenation and lessens the need for extracorporeal-membrane oxygenation in full-term neonates with hypoxaemic respiratory failure and persistent pulmonary hypertension, but potential adverse effects are intracranial haemorrhage and chronic lung disease. We investigated whether low-dose inhaled nitric oxide would improve survival in premature neonates with unresponsive severe hypoxaemic respiratory failure, and would not increase the frequency or severity of intracranial haemorrhage or chronic lung disease. METHODS: We did a double-blind, randomised controlled trial in 12 perinatal centres that provide tertiary care. 80 premature neonates (gestational age < or = 34 weeks) with severe hypoxaemic respiratory failure were randomly assigned inhaled nitric oxide (n=48) or no nitric oxide (n=32, controls). Our primary outcome was survival to discharge. Analysis was by intention to treat. We studied also the rate and severity of intracranial haemorrhage, pulmonary haemorrhage, duration of ventilation, and chronic lung disease at 36 weeks' postconceptional age. FINDINGS: The two groups did not differ for baseline characteristics or severity of disease. Inhaled nitric oxide improved oxygenation after 60 min (p=0.03). Survival at discharge was 52% in the inhaled-nitric-oxide group and 47% in controls (p=0.65). Causes of death were mainly related to extreme prematurity and were similar in the two groups. The two groups did not differ for adverse events or outcomes (intracranial haemorrhage grade 2-4, 28% inhaled nitric oxide and 33% control; pulmonary haemorrhage 13% and 9%; chronic lung disease 60% and 80%). INTERPRETATION: Low-dose inhaled nitric oxide improved oxygenation but did not improve survival in severely hypoxaemic premature neonates. Low-dose nitric oxide in the most critically ill premature neonates does not increase the risk of intracranial haemorrhage, and may decrease risk of chronic lung injury.

Administration, Inhalation↗

PubMed2005

Internet-based self-help for depression: randomised controlled trial.

BACKGROUND: Major depression can be treated by means of cognitive-behavioural therapy, but as skilled therapists are in short supply there is a need for self-help approaches. Many individuals with depression use the internet for discussion of symptoms and to share their experience. AIMS: To investigate the effects of an internet-administered self-help programme including participation in a monitored, web-based discussion group, compared with participation in web-based discussion group only. METHOD: A randomised controlled trial was conducted to compare the effects of internet-based cognitive-behavioural therapy with minimal therapist contact (plus participation in a discussion group) with the effects of participation in a discussion group only. RESULTS: Internet-based therapy with minimal therapist contact, combined with activity in a discussion group, resulted in greater reductions of depressive symptoms compared with activity in a discussion group only (waiting-list control group). At 6 months' follow-up, improvement was maintained to a large extent. CONCLUSIONS: Internet-delivered cognitive cognitive-behavioural therapy should be pursued further as a complement or treatment alternative for mild-to-moderate depression.

Adult↗

PubMed1983

Benefits of supplementary tube feeding after fractured neck of femur: a randomised controlled trial.

A total of 744 elderly women with fractured neck of femur were classified into three groups according to anthropometric measurements on admission: group 1, well nourished; group 2, thin; group 3, very thin. Group 1 ate well and had a low mortality and a short rehabilitation time. The thinner the patients the lower their voluntary food intake, the higher their mortality and the longer their rehabilitation time. A series of 122 patients from groups 2 and 3 were entered postoperatively into a randomised controlled trial of overnight supplementary nasogastric tube feeding (4.2 MJ (1000 kcal), including 28 g protein) in addition to their normal ward diet. This treatment was associated with improvements not only in anthropometric and plasma protein measurements but also in clinical outcome, especially in the very thin group 3 patients. Rehabilitation time and hospital stay were shortened. Mortality in group 3 was less in the tube fed patients (8%) than in the controls (22%) but this difference did not reach statistical significance. One in five patients could not tolerate the nasogastric tube, but in the remainder the treatment caused no side effects and did not seriously diminish voluntary oral food intake by day.

Aged↗

PubMed2006

Use of nicotine replacement therapy in socioeconomically deprived young smokers: a community-based pilot randomised controlled trial.

BACKGROUND: Smoking is common in young people, particularly in disadvantaged groups, and continued smoking has a major impact on quality and quantity of life. Although many young smokers want to stop smoking, little is known about the design and effectiveness of cessation services for them. OBJECTIVE: To determine whether nicotine replacement therapy (NRT) when combined with counselling is effective in young smokers in a deprived area of Nottingham, UK. METHODS AND SUBJECTS: We surveyed smoking prevalence and attitudes to smoking and quitting in young people accessing an open access youth project in a deprived area of Nottingham, and used the information gained to design a community based smoking cessation service incorporating a randomised controlled trial of nicotine patches against placebo given in association with individual behavioural support. We resurveyed smoking prevalence among project attendees after completing the pilot study. RESULTS: Of 264 young people surveyed (median age 14 years, range 11-21), 49% were regular smokers. A total of 98 young people were recruited and randomised to receive either active nicotine patches on a six week reducing dose regimen (49 participants), or placebo (49 participants). Adherence to therapy was low, the median duration being one week, and 63 participants did not attend any follow up. At four weeks, five subjects receiving active NRT and two receiving placebo were abstinent, and at 13 weeks none were. Adverse effects were more common in the active group but none were serious. Smoking prevalence among 246 youth project attendees surveyed after the trial was 44%. CONCLUSIONS: This study suggests that NRT in this context is unlikely to be effective in young smokers, not least because of low adherence to therapy. It also suggests that young smokers want help with smoking cessation, but that establishing the efficacy of smoking cessation services for young people who need them most will be very difficult.

Administration, Cutaneous↗

PubMed2004

Doubling the dose of inhaled corticosteroid to prevent asthma exacerbations: randomised controlled trial.

BACKGROUND: Asthma self-management plans that include doubling the dose of inhaled corticosteroid when the condition deteriorates improve asthma control. Whether doubling the dose of corticosteroid in isolation is effective is unknown. We undertook a randomised controlled trial to investigate the effects of doubling the dose of inhaled corticosteriods when asthma deteriorates. METHODS: 390 individuals with asthma who were at risk of an exacerbation monitored their morning peak flow and asthma symptoms for up to 12 months. When peak flow or symptoms started to deteriorate, participants added an active or placebo corticosteroid inhaler to their usual corticosteroid for 14 days to produce a doubling or no change in dose. The primary outcome was the number of individuals starting oral prednisolone in each group. FINDINGS: During 12 months, 207 (53%) started their study inhaler and 46 (12%) started prednisolone--22 (11%) of 192 and 24 (12%) of 198 in the active and placebo groups, respectively. The risk ratio for starting prednisolone was therefore 0.95 (95% CI 0.55-1.64, p=0.8). INTERPRETATION: We recorded little evidence to support the widely recommended intervention of doubling the dose of inhaled corticosteroid when asthma control starts to deteriorate.

Acute Disease↗

PubMedDate not supplied

The United Kingdom Infantile Spasms Study comparing vigabatrin with prednisolone or tetracosactide at 14 days: a multicentre, randomised controlled trial.

BACKGROUND: Infantile spasms, which comprise a severe infantile seizure disorder, have a high morbidity and are difficult to treat. Hormonal treatments (adrenocorticotropic hormone and prednisolone) have been the main therapy for decades, although little evidence supports their use. Vigabatrin has been recorded to have a beneficial effect in this disorder. We aimed to compare the effects of vigabatrin with those of prednisolone and tetracosactide in the treatment of infantile spasms. METHODS: The United Kingdom Infantile Spasms Study assessed these treatments in a multicentre, randomised controlled trial in 150 hospitals in the UK. The primary outcome was cessation of spasms on days 13 and 14. Minimum doses were vigabatrin 100 mg/kg per day, oral prednisolone 40 mg per day, or intramuscular tetracosactide depot 0.5 mg (40 IU) on alternate days. Analysis was by intention to treat. FINDINGS: Of 208 infants screened and assessed, 107 were randomly assigned to vigabatrin (n=52) or hormonal treatments (prednisolone n=30, tetracosactide n=25). None was lost to follow-up. Proportions with no spasms on days 13 and 14 were: 40 (73%) of 55 infants assigned hormonal treatments (prednisolone 21/30 [70%], tetracosactide 19/25 [76%]) and 28 (54%) of 52 infants assigned vigabatrin (difference 19%, 95% CI 1%-36%, p=0.043). Two infants allocated tetracosactide and one allocated vigabatrin received prednisolone. Adverse events were reported in 30 (55%) of 55 infants on hormonal treatments and 28 (54%) of 52 infants on vigabatrin. No deaths were recorded. INTERPRETATION: Cessation of spasms was more likely in infants given hormonal treatments than those given vigabatrin. Adverse events were common with both treatments.

Anticonvulsants↗

PubMed2006

TCH346 as a neuroprotective drug in Parkinson's disease: a double-blind, randomised, controlled trial.

BACKGROUND: There is an important unmet medical need in Parkinson's disease for a neuroprotective treatment that slows or stops disease progression. TCH346 is a potent anti-apoptotic drug that protects against loss of dopaminergic neurons in laboratory models. Our aim was to assess TCH346 as a neuroprotective drug in patients with Parkinson's disease. METHODS: Patients presenting at 45 international movement disorder clinics with early untreated Parkinson's disease were assessed as part of this parallel-group, double-blind, randomised controlled trial. 301 eligible patients were randomly assigned 12-18 months' treatment with TCH346 at a daily dose of 0.5 mg (n=78), 2.5 mg (n=79), or 10 mg (n=73), or placebo (n=71), followed by a 4 week washout period. The primary outcome measure was time to development of a disability requiring dopaminergic treatment. Secondary outcome measures were the annual rate of change in the unified Parkinson's disease rating scale (UPDRS) and the PDQ-39, a measure of quality of life. Analyses were by intention-to-treat. This study is pending registration with . FINDINGS: 255 patients completed the study. TCH346 did not differ from placebo for any of the study outcomes. Treatment was needed in 26 (34%) patients in the TCH346 0.5 mg group, 30 (38%) in the TCH346 2.5 mg group, 24 (33%) in the TCH346 10 mg group, and 23 (32%) in the placebo group. There were no significant differences between groups. There were no differences between groups in the annual change in the UPDRS or PDQ-39 either. Few patients withdrew because of adverse events and none was judged to be related to the study intervention. INTERPRETATION: TCH346 did not show evidence of a neuroprotective effect. The discrepancy between the preclinical promise of TCH346 and the clinical outcome could have arisen because of the use of laboratory models that do not accurately reflect the pathogenesis of Parkinson's disease, the doses of study drug used, insensitive clinical endpoints, and the patient population selected for study.

Adult↗

PubMed2005

High-dose fish oil and antioxidants in Crohn's disease and the response of bone turnover: a randomised controlled trial.

Crohn's disease is associated with altered bone turnover that may be influenced by nutritional status, the systemic inflammatory response, cytokine production by circulating (peripheral blood) mononuclear cells (PBMC) and antioxidant micronutrient intake. High-dose fish oil is associated with reductions in disease relapse and inflammatory markers, and modulates PBMC function. The effect of fish oil plus antioxidants on bone turnover and PBMC function (the production of interferon-gamma and prostaglandin E2) in Crohn's disease was investigated in a randomised-controlled trial. Patients with currently or recently raised biochemical markers of inflammation (C-reactive protein > or = 6.9 mg/l or erythrocyte sedimentation rate > or =18 mm/h) received fish oil (providing 2.7 g/d EPA and DHA) and antioxidants (vitamins A, C and E, and Se) (n 31) or placebo (n 30) for 24 weeks. Bone turnover was assessed by measuring the concentrations of urinary deoxypyridinoline (bone resorption) and serum osteocalcin (bone formation). Fish oil plus antioxidants were associated with increases in EPA, DHA Se in plasma (all P < 0.01), and with a reduction in interferon-gamma production by mitogen-stimulated PBMC, which demonstrated a negative correlation with deoxypyridinoline/creatinine:osteocalcin ratio (r - 0.33, P = 0.009). There were no differences between the groups at 24 weeks in the response of deoxypyridinoline or osteocalcin or their ratio, or in nutritional status. Dietary supplementation in Crohn's disease with high intakes of EPA and DHA, as fish oil, plus antioxidants was associated with a modulated production of interferon-gamma by PBMC but not altered indices of bone turnover.

Amino Acids↗

PubMed2005

Effect on survey response rate of hand written versus printed signature on a covering letter: randomised controlled trial [ISRCTN67566265].

BACKGROUND: It is important that response rates to postal surveys are as high as possible to ensure that the results are representative and to maximise statistical power. Previous research has suggested that any personalisation of approach helps to improve the response rate. This experiment tested whether personalising questionnaires by hand signing the covering letter improved the response rate compared with a non-personalised group where the investigator's signature on the covering letter was scanned into the document and printed. METHODS: Randomised controlled trial. Questionnaires about surgical techniques of caesarean section were mailed to 3,799 Members and Fellows of the Royal College of Obstetricians and Gynaecologists resident in the UK. Individuals were randomly allocated to receive a covering letter with either a computer printed signature or a hand written signature. Two reminders were sent to non-respondents. The outcome measures were the proportion of questionnaires returned and their time to return. RESULTS: The response rate was 79.1% (1506/1905) in the hand-signed group and 78.4% (1484/1894) in the scanned and printed signature group. There was no detectable difference between the groups in response rate or time taken to respond. CONCLUSION: No advantage was detected to hand signing the covering letter accompanying a postal questionnaire to health professionals.

Adult↗

PubMed2001

A randomised controlled trial of four management strategies for dyspepsia: relationships between symptom subgroups and strategy outcome.

BACKGROUND: The first step in the management of uncomplicated dyspepsia in primary care often consists of prescribing empirical therapy, but in certain cases prompt endoscopy might be preferred. Any decision is usually based on the patient's symptoms and the presumed underlying pathology that causes these symptoms. AIM: To assess the relationship between symptom subgroups and the effect of management strategies on primary care patients with dyspepsia. DESIGN OF STUDY: Randomised controlled trial. SETTING: All patients presenting successively with a new episode of dyspepsia between January 1995 and November 1997. METHOD: The results of four management strategies in dyspeptic primary care patients were compared and the value of subgrouping within this trial was estimated. Patients were allocated to one of either (a) empirical treatment in which therapy was based on the presented symptoms, or empirical treatment with (b) omeprazole or (c) cisapride regardless of the presented symptoms, or (d) prompt endoscopy followed by the appropriate treatment. Patients were retrospectively classified into the subgroups for each strategy using baseline data. The yield of each strategy was measured by counting the number of strategy failures in the first year. RESULTS: Of the 349 included patients, 326 were analysed. No statistically significant difference could be demonstrated between the strategies or between the symptom subgroups. However, patients in the reflux-like subgroup showed a trend towards a better outcome in all empirical strategies. Ulcer-like dyspepsia seemed to benefit from omeprazole. The non-specific subgroup seemed to benefit from cisapride but also had the highest proportion of strategy failure. Prompt endoscopy did not appear especially useful in any subgroup. CONCLUSION: Although this study has relatively low power, we conclude that the use of symptom subgroups seems to be a sensible approach when choosing empirical therapy in dyspepsia. Patients with reflux-like symptoms seem to have the best prognosis in the first year in every strategy.

Anti-Ulcer Agents↗

PubMed2006

Randomised controlled trial of the efficacy of a metered dose inhaler with bottle spacer for bronchodilator treatment in acute lower airway obstruction.

BACKGROUND: Inhaled bronchodilator treatment given via a metered dose inhaler (MDI) and spacer is optimal for relief of bronchoconstriction. Conventional spacers are expensive or unavailable in developing countries, but there is little information on the efficacy of low-cost spacers in young children. OBJECTIVE: To compare the response to bronchodilator treatment given via a conventional or a low-cost bottle spacer METHODS: A randomised controlled trial of the efficacy of a conventional spacer compared with a bottle spacer for bronchodilator treatment in young children with acute lower airway obstruction. Bronchodilator treatment was given from an MDI via an Aerochamber or a bottle spacer. Clinical score and oximetry recording were carried out before and after 15 min of treatment. MDI-spacer treatment was repeated up to three times, depending on clinical response, after which nebulisation was used. The primary outcome was hospitalisation. RESULTS: 400 children, aged (median (25th-75th centile)) 12 (6-25) months, were enrolled. The number of children hospitalised (n = 60, 15%) was identical in the conventional and bottle spacer groups (n = 30, 15% in each). Secondary outcomes including change in clinical score (-2 (-3 to -1)), oxygen saturation (0 (-1 to 1)) and number of bronchodilator treatments (2 (1 to 3)) were similar in both groups. Oral corticosteroids, prescribed for 78 (19.5%) children, were given to a similar number in the conventional (37 (18.5%)) and bottle spacer groups (41 (20.5%)). CONCLUSION: A low-cost bottle spacer is as effective as a conventional spacer for bronchodilator treatment in young children with acute obstruction of the lower airways.

Asthma↗

PubMed2002

Telephone consultations to manage requests for same-day appointments: a randomised controlled trial in two practices.

BACKGROUND: General practitioners (GPs) in the United Kingdom have recently begun to adopt the use of telephone consultation during daytime surgery as a means of managing demand, particularly requests for same-day appointments. However, it is not known whether the strategy actually reduces GP workload. AIM: To investigate how the use of telephone consultations impacts on the management of requests for same-day appointments, on resource use, indicators of clinical care, and patient perceptions of consultations. DESIGN OF STUDY: Randomised controlled trial. SETTING: All patients (n = 388) seeking same-day appointments in each surgery in two urban practices (total population = 10,420) over a four-week period. METHOD: The primary outcome measure was use of doctor time for the index telephone or face-to-face consultation. Secondary outcomes were subsequent use of investigations and of services in the two-week period following consultation, frequency of blood pressure measurement and antibiotic prescriptions, and number of problems considered at consultation. Patient perceptions were measured by the Patient Enablement Instrument (PEI) and reported willingness to use telephone consultations in the future. RESULTS: Telephone consultations took less time (8.2 minutes versus 6.7 minutes; diff = 1.5, 95% confidence interval [CI] = 0.6 to 2.4, P = 0.002). Patients consulting by telephone reconsulted the GP more frequently in the two weeks that followed (0.6 consultations versus 0.4 consultations; diff = 0.2, 95% CI = 0.0 to 0.3, P = 0.01). Blood pressure was measured more often in the group of patients managed face-to-face (25/188 [13.3%] versus 12/181 [6.6%]; diff = 6.7%, 95% CI = 0.6% to 12.7%). There was no significant difference in patient perceptions or other secondary outcomes. CONCLUSION: Use of telephone consultations for same-day appointments was associated with time saving, and did not result in lower PEI scores. Possibly, however, this short-term saving was offset by higher re-consultation and less use of opportunistic health promotion.

Appointments and Schedules↗

PubMed2003

Double-blind randomised controlled trial comparing Merocel with Rapid Rhino nasal packs after routine nasal surgery.

INTRODUCTION: Nasal packing after routine nasal surgery is commonly practiced in the UK. The most popular pack appears to be Merocel, however this can be associated with significant pain on its removal. AIM: To test the efficacy of a relatively new nasal pack--the Rapid Rhino Goodman pack--introduced to our department, which claims to reduce pain and bleeding after nasal surgery. METHODS: Fourteen patients undergoing routine nasal surgery were recruited into a randomised controlled trial. One nasal cavity was packed with a Merocel pack and the other with a Rapid Rhino Goodman pack. Patients were asked to record pain levels on each side using a visual analogue scale. RESULTS: We found no difference between packs whilst in-situ, with all patients recording low to moderate pain scores. There were significantly higher pain levels associated with Merocel pack removal than with Rapid Rhino pack removal (average pain scores 5.64 vs 1.64, p < 0.001) and less bleeding overall. CONCLUSIONS: Rapid Rhino (Goodman pack) is associated with significantly less pain on removal than Merocel pack, causes less bleeding and is not more painful whilst in-situ. We therefore recommend its use in routine nasal surgery.

Adolescent↗

PubMed2003

Estimating psychological treatment effects from a randomised controlled trial with both non-compliance and loss to follow-up.

BACKGROUND: The Outcomes of Depression International Network (ODIN) trial evaluated the effect of two psychological interventions for the treatment of depression in primary care. Only about half of the patients in the treatment arm complied with the offer of treatment, prompting the question:'what was the effect of treatment in those patients who actually received it?' AIMS: To illustrate the estimation of the effect of receipt of treatment in a randomised controlled trial subject to non-compliance and loss to follow-up. METHOD: We estimated the complier average causal effect (CACE) of treatment. RESULTS: In the ODIN trial the effect of receipt of psychological intervention (an average of about 4 points on the Beck Depression Inventory) is about twice that of offering it. CONCLUSIONS: The statistical analysis of the results of a clinical trial subject to non-compliance to allocated treatment is now reasonably straightforward through estimation of a CACE and investigators should be encouraged to present the results of analyses of this type as a routine component of a trial report.

Data Interpretation, Statistical↗

PubMed2003

An exploratory randomised controlled trial of a support programme for carers of patients with a psychosis.

BACKGROUND: Despite an acknowledgement of the impact of serious mental disorders on informal caregivers, we still know little about how to best help them. The aim of the study was to evaluate the effectiveness of a two-phased carers' intervention comprising family sessions followed by relatives' groups. This intervention was designed to be of 'intermediate' intensity, that is,one lying between brief educational programmes and long-term family psychoeducational treatments. METHODS: An exploratory randomised controlled trial was conducted comparing the experimental support programme with 'standard' care. All carers of patients with a psychotic disorder from a defined population were approached. Outcome measures were based on a 'stress-appraisal-coping' model of caregiving. RESULTS: Despite concerted attempts to engage carers, only 42% participated in the study. The carers' programme did not offer any significant advantage on any of the outcome measures: psychological morbidity, negative appraisal, coping or social support. The severity of caregiving difficulties decreased over the study period for the group as a whole. CONCLUSIONS: There is still uncertainty about the most effective interventions for carers. Meeting 'needs' may not improve caregiver distress.

Adaptation, Psychological↗

PubMed2006

A randomised control trial comparing lifestyle groups, individual counselling and written information in the management of weight and health outcomes over 12 months.

OBJECTIVE: To investigate the effect of an 8-week group-based cognitive behaviour therapy lifestyle intervention with monthly follow-up to 6 months and further follow up at 12 months on change in weight and other weight-related variables, change in physical activity and change in health and well being compared to individualised dietetic treatment or giving an information booklet only (BO). DESIGN: A randomised controlled trial of two intervention groups, a group-based cognitive behaviour therapy lifestyle intervention, Fat Booters Incorporated--(FBI) and individualised dietetic treatment (IDT) and control group receiving an information booklet only (BO). The intervention groups involved weekly contact for 8 weeks with monthly follow-up to 6 months and further follow-up at 12 months, conducted in real practice setting. SUBJECTS: A total of 176 adults with body mass index (BMI)>27 kg/m2, mean (+/-s.d.) age 48+/-13 years, mean BMI 34+/-5.5 kg/m2. MAIN OUTCOME MEASURES: Weight, percent body fat, waist circumference, physical activity, health status, self-efficacy and satisfaction with life were measured at baseline, 3, 6 and 12 months. RESULTS: A statistically significant difference between groups was observed for weight change over time (P=0.05). The change in weight (mean+/-s.e.) for the FBI group was significantly greater than the BO group at 3 and 12 months (-2.8+/-0.7 compared to -1.0+/-0.6 kg, P<0.05 and -2.9+/-0.9 compared to +0.5+/-0.9 kg, P<0.005, respectively). Change in weight in the IDT group did not differ from the FBI group at any time point. For all groups, waist circumference was significantly less than baseline at all time points (P<0.001). Significant differences in self-efficacy were observed over time (P=0.02), with both intervention groups having greater self-efficacy than the BO group. Significant drop-outs occurred over time for all three groups. CONCLUSIONS: A cognitive behaviour-based lifestyle intervention was more effective than providing an information booklet alone and as effective as intensive individualised dietetic intervention in weight loss and improvements in self-efficacy.

Adult↗

PubMed2002

Effects of fruit and vegetable consumption on plasma antioxidant concentrations and blood pressure: a randomised controlled trial.

BACKGROUND: High dietary intakes of fruit and vegetables are associated with reduced risks of cancer and cardiovascular disease. Short-term intensive dietary interventions in selected populations increase fruit and vegetable intake, raise plasma antioxidant concentrations, and lower blood pressure, but long-term effects of interventions in the general population are not certain. We assessed the effect of an intervention to increase fruit and vegetable consumption on plasma concentrations of antioxidant vitamins, daily fruit and vegetable intake, and blood pressure. METHODS: We undertook a 6-month, randomised, controlled trial of a brief negotiation method to encourage an increase in consumption of fruit and vegetables to at least five daily portions. We included 690 healthy participants aged 25-64 years recruited from a primary-care health centre. FINDINGS: Plasma concentrations of alpha-carotene, beta-carotene, lutein, beta-cryptoxanthin, and ascorbic acid increased by more in the intervention group than in controls (significance of between-group differences ranged from p=0.032 to 0.0002). Groups did not differ for changes in lycopene, retinol, alpha-tocopherol, gamma-tocopherol, or total cholesterol concentrations. Self-reported fruit and vegetable intake increased by a mean 1.4 (SD 1.7) portions in the intervention group and by 0.1 (1.3) portion in the control group (between-group difference=1.4, 95% CI 1.2-1.6; p<0.0001). Systolic blood pressure fell more in the intervention group than in controls (difference=4.0 mm Hg, 2.0-6.0; p<0.0001), as did diastolic blood pressure (1.5 mm Hg, 0.2-2.7; p=0.02). INTERPRETATION: The effects of the intervention on fruit and vegetable consumption, plasma antioxidants, and blood pressure would be expected to reduce cardiovascular disease in the general population.

Adult↗