OBJECTIVE: Studies have suggested that total intake of trans-fatty acids (TFA) is positively associated with changes in body weight and waist circumference, whereas intake of TFA from ruminant dairy and meat products (R-TFA) has not been associated with weight gain. However, these previous studies are limited by self-reported measures of body weight and waist circumference or by a cross-sectional design. The objective of the present study was to investigate if R-TFA intake was associated with subsequent changes in anthropometry (body weight, waist and hip circumference) measured by technicians and body composition (body fat percentage).

DESIGN: A 6-year follow-up study. Information on dietary intake was collected through diet history interviews, and anthropometric and bioelectrical impedance measurements were obtained by trained technicians at baseline (1987-1988) and at follow-up (1993-1994). Multiple regression with cubic spline modelling was used to analyse the data.

SETTING: Copenhagen County, Denmark.

SUBJECTS: Two hundred and sixty-seven men and women aged 35-65 years from the Danish MONICA (MONItoring of trends and determinants in CArdiovascular diseases) cohort.

RESULTS: The median R-TFA intake was 1·3 g/d (5th, 95th percentile: 0·4, 2·7 g/d) or 0·6 % of the total energy intake (5th, 95th percentile: 0·2, 1·1 %). No significant associations were observed between R-TFA intake and changes in body weight, waist and hip circumference or body fat percentage.

CONCLUSIONS: R-TFA intake within the range present in the Danish population was not significantly associated with subsequent changes in body size, shape or composition and the 95 % confidence intervals indicate that any relevant associations are unlikely to have produced these observations.

OBJECTIVE: This study examined the influence of weight loss on long-term morbidity and mortality in overweight (BMI≥25kg/m2) patients with type 2 diabetes, and tested the hypothesis that therapeutic intentional weight loss supervised by a medical doctor prolongs life and reduces the risk for cardiovascular disease in these patients.

METHODS: This is a 19 year cohort study of patients in the intervention arm of the randomized clinical trial Diabetes Care in General Practice. Weight and prospective intentions for weight loss were monitored every third month for six years in 761 consecutive patients (≥40 years) newly diagnosed with diabetes in general practices throughout Denmark in 1989-92. Multivariable Cox regression was used to estimate the association between weight change during the monitoring period (year 0 to 6) and the outcomes during the succeeding 13 years (year 6 to 19) in 444 patients who were overweight at diagnosis and alive at the end of the monitoring period (year 6). The analysis was adjusted for age, sex, education, BMI at diagnosis, change in smoking, change in physical activity, change in medication, and the Charlson comorbidity 6-year score. Outcomes were from national registers.

RESULTS: Overall, weight loss regardless of intention was an independent risk factor for increased all-cause mortality (P<0.01). The adjusted hazard ratio for all-cause mortality, cardiovascular mortality, and cardiovascular morbidity attributable to an intentional weight loss of 1 kg/year was 1.20 (95%CI 0.97-1.50, P = 0.10), 1.26 (0.93-1.72, P = 0.14), and 1.06 (0.79-1.42, P = 0.71), respectively. Limiting the analysis to include only those patients who survived the first 2 years after the monitoring period did not substantially change these estimates. A non-linear spline estimate indicated a V-like association between weight change and all-cause mortality, suggesting the best prognosis for those who maintained their weight.

CONCLUSIONS: In this population-based cohort of overweight patients with type 2 diabetes, successful therapeutic intentional weight loss, supervised by a doctor over six years, was not associated with reduced all-cause mortality or cardiovascular morbidity/mortality during the succeeding 13 years.

OBJECTIVE: To assess the effects of one intra-articular corticosteroid injection two weeks prior to an exercise-based intervention program for reducing pain sensitivity in patients with knee osteoarthritis (OA).

DESIGN: Randomized, masked, parallel, placebo-controlled trial involving 100 participants with clinical and radiographic knee OA that were randomized to one intra-articular injection on the knee with either 1 ml of 40 mg/ml methylprednisolone (corticosteroid) dissolved in 4 ml lidocaine (10 mg/ml) or 1 ml isotonic saline (placebo) mixed with 4 ml lidocaine (10 mg/ml). Two weeks after the injections all participants undertook a 12-week supervised exercise program. Main outcomes were changes from baseline in pressure-pain sensitivity (pressure-pain threshold [PPT] and temporal summation [TS]) assessed using cuff pressure algometry on the calf. These were exploratory outcomes from a randomized controlled trial.

RESULTS: A total of 100 patients were randomized to receive either corticosteroid (n = 50) or placebo (n = 50); 45 and 44, respectively, completed the trial. Four participants had missing values for PPT and one for TS at baseline; thus modified intention-to-treat populations were analyzed. The mean group difference in changes from baseline at week 14 was 0.6 kPa (95% CI: -1.7 to 2.8; P = 0.626) for PPT and 384 mm×sec (95% CI: -2980 to 3750; P = 0.821) for TS.

CONCLUSIONS: These results suggest that adding intra-articular corticosteroid injection 2 weeks prior to an exercise program does not provide additional benefits compared to placebo in reducing pain sensitivity in patients with knee OA.

TRIAL REGISTRATION: EU clinical trials (EudraCT): 2012-002607-18.

OBJECTIVE: To conduct a systematic review and meta-analysis to synthesize evidence regarding measurement properties of the Knee injury and Osteoarthritis Outcome Score (KOOS).

DESIGN: A comprehensive literature search identified 37 eligible papers evaluating KOOS measurement properties in participants with knee injuries and/or osteoarthritis (OA). Methodological quality was evaluated using the COSMIN checklist. Where possible, meta-analysis of extracted data was conducted for all studies and stratified by age and knee condition; otherwise narrative synthesis was performed.

RESULTS: KOOS has adequate internal consistency, test-retest reliability and construct validity in young and old adults with knee injuries and/or OA. The ADL subscale has better content validity for older patients and Sport/Rec for younger patients with knee injuries, while the Pain subscale is more relevant for painful knee conditions. The five-factor structure of the original KOOS is unclear. There is some evidence that the KOOS subscales demonstrate sufficient unidimensionality, but this requires confirmation. Although measurement error requires further evaluation, the minimal detectable change for KOOS subscales ranges from 14.3 to 19.6 for younger individuals, and ≥20 for older individuals. Evidence of responsiveness comes from larger effect sizes following surgical (especially total knee replacement) than non-surgical interventions.

CONCLUSIONS: KOOS demonstrates adequate content validity, internal consistency, test-retest reliability, construct validity and responsiveness for age- and condition-relevant subscales. Structural validity, cross-cultural validity and measurement error require further evaluation, as well as construct validity of KOOS Physical function Short form. Suggested order of subscales for different knee conditions can be applied in hierarchical testing of endpoints in clinical trials.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42011001603).

Higher protein intake, and particularly higher leucine intake, is associated with attenuated loss of lean body mass (LBM) over time in older individuals. Dietary leucine is thought to be a key mediator of anabolism. This study aimed to assess this relationship over 6 years among younger and older adult Danes. Dietary leucine intake was assessed at baseline and after 6 years in men and women, aged 35-65 years, participating in the Danish cohort of the WHO-MONICA (Multinational MONItoring of trends and determinants in CArdiovascular disease) study (n 368). Changes in LBM over the 6 years were measured by bioelectrical impedance using equations developed for this Danish population. The association between leucine and LBM changes was examined using multivariate linear regression and ANCOVA analyses adjusted for potential confounders. After adjustment for baseline LBM, sex, age, energy intake and physical activity, leucine intake was associated with LBM change in those older than 65 years (n 79), with no effect seen in those younger than 65 years. Older participants in the highest quartile of leucine intake (7·1 g/d) experienced LBM maintenance, whereas lower intakes were associated with LBM loss over 6 years (for trend: β=0·434, P=0·03). Sensitivity analysis indicated no effect modification of sex or the presence of CVD. Greater leucine intake in conjunction with adequate total protein intake was associated with long-term LBM retention in a healthy older Danish population. This study corroborates findings from laboratory investigations in relation to protein and leucine intakes and LBM change. A more diverse and larger sample is needed for confirmation of these results.

BACKGROUND: Weight reduction may reduce the severity of psoriasis, but little is known about the long-term effects.

OBJECTIVE: We aimed to investigate long-term effects of weight reduction in psoriasis.

DESIGN: We previously conducted a randomized trial (n = 60) involving patients with psoriasis who were allocated to a control group or a low-energy diet (LED) group. Here we followed the participants for an additional 48-wk period. In total, 56 patients with psoriasis [mean ± SD body mass index (in kg/m(2)): 34.4 ± 5.3] underwent a 64-wk weight-loss program consisting of an initial 16-wk randomized phase with an LED for 8 wk and 8 wk of normal food intake combined with 2 LED products/d, followed by a 48-wk period of weight maintenance with the latter diet. After the randomization phase, the control group received the same 8 + 8-wk LED intervention, and all patients were then followed for 48 wk while on the weight-loss maintenance diet. The main outcome was the Psoriasis Area and Severity Index (PASI), and secondary outcome was the Dermatology Life Quality Index (DLQI).

RESULTS: For the present study, 56 patients were eligible, 38 agreed to participate, and 32 completed. After the 16-wk LED-only period, the mean weight loss was -15.0 kg (95% CI: -16.6, -13.4 kg), and PASI and DLQI were reduced by -2.3 (95% CI: -3.1, -1.5) and -2.3 (95% CI: -3.2, -1.4), respectively. At week 64, the mean weight loss compared with baseline was -10.1 kg (95% CI: -12.0, -8.1 kg), and PASI and DLQI were maintained at -2.9 (95% CI: -3.9, -1.9) and -1.9 (95% CI: -3.0, -0.9), respectively.

CONCLUSION: Long-term weight loss in patients with psoriasis has long-lasting positive effects on the severity of psoriasis. This trial was registered at clinicaltrials.gov as NCT01137188.

OBJECTIVE: To investigate whether analysis of the modified intention-to-treat (mITT) population with post-randomisation exclusion of patients from analysis is associated with biased estimates of treatment effect compared to the conservative intention-to-treat (ITT) population.

STUDY DESIGN AND SETTING: Placebo-controlled, blinded randomised trials on biological or targeted interventions for rheumatoid arthritis were identified through a systematic search. Two authors independently extracted data. A random-effects meta-analysis was used to combine odds ratios as an expression of treatment effect and stratify according to the different analysis populations.

RESULTS: Seventy-two randomised trials were included and analysed (23,842 patients). Thirty trials analysed the ITT population, 37 analysed an mITT population, and 5 trials had an unclear analysis population. The treatment effect of active intervention compared to control, when based on mITT, was comparable to ITT (odds ratio 3.76 [95% confidence interval 3.09 to 4.57], and 3.47 [2.77 to 4.34]; comparison P=0.60).

CONCLUSION: We found no difference in the treatment effect between randomised trials using ITT and mITT analyses populations. This suggests that the mITT approach in rheumatoid arthritis trials investigating biological or targeted interventions does not introduce bias compared to ITT.

OBJECTIVE: The objective was to evaluate a manualized theory-driven primary preventive intervention aimed at early childhood obesity. The intervention was embedded in Swedish child health services, starting when eligible children were 9 to 10 months of age and continuing until the children reached age 4.

METHODS: Child health care centers in 8 Swedish counties were randomized into intervention and control units and included 1355 families with 1369 infants. Over ∼39 months, families in the intervention group participated in 1 group session and 8 individual sessions with a nurse trained in motivational interviewing, focusing on healthy food habits and physical activity. Families in the control group received care as usual. Primary outcomes were children's BMI, overweight prevalence, and waist circumference at age 4. Secondary outcomes were children's and mothers' food and physical activity habits and mothers' anthropometrics. Effects were assessed in linear and log-binominal regression models using generalized estimating equations.

RESULTS: There were no statistically significant differences in children's BMI (β = -0.11, 95% confidence interval [CI]: -0.31 to 0.08), waist circumference (β = -0.48, 95% CI: -0.99 to 0.04), and prevalence of overweight (relative risk = 0.95, 95% CI: 0.69 to 1.32). No significant intervention effects were observed in mothers' anthropometric data or regarding mothers' and children's physical activity habits. There was a small intervention effect in terms of healthier food habits among children and mothers.

CONCLUSIONS: There were no significant group differences in children's and mothers' anthropometric data and physical activity habits. There was, however, some evidence suggesting healthier food habits, but this should be interpreted with caution.