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Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study.

ABSTRACT: There is a permanent need to evaluate and develop the ethical quality of scientific research and to widen knowledge about the effects of ethical issues. Therefore we evaluated whether informed consent is related to implementation and success in a lifestyle intervention study with older research participants. There is little empirical research into this topic.The subjects (n = 597) are a subgroup of a random population sample of 1410 men and women aged 57-78 years who are participating in a 4-year randomized controlled intervention trial on the effects of physical exercise and diet on atherosclerosis, endothelial function and cognition. Data were collected in two steps: A questionnaire about informed consent was given to all willing participants (n = 1324) three months after the randomization. Data on implementation and success in the exercise and diet interventions were evaluated at 12 months by intervention-group personnel. The main purpose of the analysis procedure performed in this study was to identify and examine potential correlates for the chosen dependent variables and to generate future hypotheses for testing and confirming the independent determinants for implementation and success. The nature of the analysis protocol is exploratory at this stage.About half of the participants (54%) had achieved good results in the intervention. Nearly half of the participants (47%) had added to or improved their own activity in some sector of exercise or diet. Significant associations were found between performance in the interventions and participants' knowledge of the purpose of the study (p < 0.001), and between success in interventions and working status (p = 0.02), and the participants' knowledge of the purpose of the study (p = 0.04).The main finding of this study was that those participants who were most aware or had understood the purpose of the study at an early stage had also attained better results at their 12-month intervention evaluation. Therefore, implementation and success in intervention is related to whether subjects receive a sufficient amount and are able to comprehend the information provided i.e. the core principles of informed consent.(ISRCTN 45977199).

SUBMITTER: Lansimies-Antikainen H

PROVIDER: S-EPMC2891796 | biostudies-other | 2010 Jun

REPOSITORIES: biostudies-other

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Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study.

Länsimies-Antikainen Helena H Pietilä Anna-Maija AM Laitinen Tomi T Kiviniemi Vesa V Rauramaa Rainer R

BMC medical ethics 20100608

<h4>Background</h4>There is a permanent need to evaluate and develop the ethical quality of scientific research and to widen knowledge about the effects of ethical issues. Therefore we evaluated whether informed consent is related to implementation and success in a lifestyle intervention study with older research participants. There is little empirical research into this topic.<h4>Methods</h4>The subjects (n = 597) are a subgroup of a random population sample of 1410 men and women aged 57-78 yea ...[more]

PMID: 20529340

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Project description:BackgroundExercise interventions can result in weight loss, which is associated with reductions in disease risk. It is unknown how the volume of exercise prescribed in a one-time exercise intervention impacts long-term body fatness. We compared 24-month body fat changes among postmenopausal women previously prescribed 300 versus 150 minutes/week of exercise in a year-long exercise intervention trial.MethodsThe Breast Cancer and Exercise Trial in Alberta (BETA) was a two-centred randomized controlled trial in Alberta, Canada. The trial consisted of a 12-month intervention and 12-month observation period. For the intervention, participants were randomized to either a moderate-volume exercise group (150 min/week) or a high-volume exercise group (300 min/week). Participants in this study were 334 inactive postmenopausal women who had been followed-up to 24 months. The primary outcome for this study was 24-month change in total body fat using dual energy X-ray absorptiometry scans. Other measures included weight, waist and hip circumferences, subcutaneous and intra-abdominal fat from computed tomography scans, and lean mass. Researchers were blinded to randomization group when measuring body fat.ResultsBoth groups self-reported ∼180 minutes/week moderate-vigorous activity at 24 months. No statistically significant difference was found in total body fat at 24 months between the two groups. Statistically significant effects (comparing high versus moderate groups) were found for BMI (least-square mean change (95% CI): -0.66 (-0.97, -0.36) versus -0.25 (-0.55, 0.05) kg/m2, P=0.04), waist-to-hip ratio (-0.033 (-0.040, -0.026) versus -0.023 (-0.030, -0.016), P=0.05), and subcutaneous abdominal fat area (-32.18 (-39.30, -25.06) versus -22.20 (-29.34, -15.05) cm2, P=0.04).ConclusionPrescribing 300 versus 150 minutes/week of exercise to inactive postmenopausal women resulted in some long-term greater decreases in measures of body composition but no overall differences in total body fat loss. This trail is registered with NCT01435005.

Project description:Abstract Objectives Obesity imposes risk to cardiometabolic health; however, intentional weight loss in obese older adults remains controversial. Using data from the CROSSROADS Study (clinicaltrials.gov #NCT00955903), this ancillary study investigated effects of exercise with and without intentional weight loss on changes in cardiometabolic risk assessed by four risk-scoring tools. Methods Participants (n = 134, 39% male, 23% African American, 70.2 ± 4.7 y) were randomized to exercise (n = 48), exercise + nutrient-dense weight maintenance diet (n = 44), or exercise + nutrient-dense caloric restriction of 500 kcals/day (n = 42). The following risk scores were calculated using baseline and 12-month data: Framingham risk assessment, Cardiometabolic Disease Staging (CMDS), metabolic syndrome classification by the International Diabetes Federation (IDF), and metabolic syndrome classification by the National Cholesterol Education Program's Adult Treatment Panel (ATP III). Generalized Estimating Equations were employed to determine differences between groups with ethnicity, sex, and age as covariates. Results Group-time interaction was not significant in application of IDF or ATPIII. Group-time interaction was significant for Framingham and CMDS (P = 0.005 and 0.041, respectively). Upon post-hoc analysis, significant within-group improvements in Framingham scores were observed for exercise + weight maintenance (P < 0.001, r = −1.682) and exercise + weight loss (P = 0.020, r = −0.881). In analysis of between-group differences in Framingham scores, a significant decrease was observed in the exercise + weight maintenance group (P = 0.001, r = −1.723) compared to the exercise group. For CMDS, the exercise + weight loss group had significant within-group improvements (P = 0.023, r = - 0.102). For between-group differences in CMDS, the exercise + weight loss group showed significant risk score reduction (P = 0.012, r = −0.142) compared to the exercise group. Conclusions Risk assessment by Framingham and CMDS showed greater sensitivity to change in cardiometabolic risk factors. Results suggest obese older adults can lower cardiometabolic risk by engaging in exercise + weight maintenance or exercise + weight loss by moderate caloric restriction. Funding Sources R01AG033094 NIA, K07AG043588 NIA, P30DK056336 NIDDK.

Project description:BackgroundExcess adiposity is characterized by alterations in adipokine secretion such that circulating leptin concentrations are increased with reductions in adiponectin. An emerging biomarker for the assessment of this adipose tissue (AT) dysfunction is the adiponectin:leptin (AL) ratio. A low AL ratio may be suggestive of dysfunctional AT and, consequently, a heightened cardiometabolic disease risk. This ancillary study investigated the relationship between the AL ratio and cardiometabolic health among community-dwelling older adults with obesity, as well as the effects of a 12-month exercise and diet intervention on changes in the AL ratio.MethodsParticipants (n = 163, 70.2 ± 4.7 years, 38.0% male) were randomized to the exercise only group, exercise + nutrient-dense weight maintenance group (exercise + weight maintenance), or exercise + nutrient-dense caloric restriction of 500 kcal/d group (exercise + intentional weight loss) (clinicaltrials.gov #NCT00955903). Total and regional adiposity as determined by magnetic resonance imaging (MRI) and dual-energy X-ray absorptiometry (DXA), anthropometrics, and cardiometabolic biomarkers were assessed at baseline and 12 months.ResultsThe AL ratio was significantly (p < 0.05) inversely correlated with body mass index, waist circumference, measures of adiposity, and insulin among all participants at baseline. Among females only, significant positive and inverse correlations were also observed between this ratio and high-density lipoprotein cholesterol and the inflammatory biomarkers high sensitivity C-reactive protein and interleukin-6, respectively. While controlling for biological sex, a significant time by intervention group interaction effect (p < 0.05) was observed such that the AL ratio significantly increased from baseline to study completion among participants in the exercise + weight maintenance group and exercise + intentional weight loss group. Post hoc analysis revealed that the exercise + intentional weight loss group exhibited a significantly greater AL ratio at study completion compared to other groups (p < 0.05 all).ConclusionsResults are in support of the AL ratio as a measure of AT dysfunction among older adults. Furthermore, results suggest that a 12-month exercise and diet intervention with intentional weight loss assists in improving the AL ratio in this population.

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Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study.

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Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study.

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