A population-based randomized controlled trial of the effect of combining a pedometer with an intervention toolkit on physical activity among individuals with low levels of physical activity or fitness

Objectives

To examine if receiving a pedometer along with an intervention toolkit is associated with increased physical activity, aerobic fitness and better self-rated health among individuals with low levels of physical activity or fitness.

Methods

The intervention was nested in the Danish Health Examination Survey (DANHES) and carried out in 2008. Participants were randomly assigned to either a pedometer group (n = 326) or a control group (n = 329). Physical activity, aerobic fitness, and self-rated health were measured at baseline and at 3-month follow-up, and differences were tested by Wilcoxons signed rank tests and Chi-squared tests.

Results

At follow-up, no significant differences in physical activity, aerobic fitness and self-rated health were found between the groups. However, the oldest participants in the pedometer group reported significantly more walking time compared to the controls (controls = 368 min/week, pedometer group = 680 min/week, P = 0.05). Among participants who completed the intervention, a significant effect on total walking time was observed (median difference = 225 min/week, P = 0.04).

Conclusions

The results suggest that receiving a pedometer and along with an intervention toolkit can increase walking time in older individuals, but not in younger individuals. Thus, this type of intervention offers great potential for promoting physical activity in older individuals.Trial registration number: NCT01071811     

Exploring the main and moderating effects of individual-level characteristics on consumer responses to sugar taxes and front-of-pack nutrition labels in an experimental marketplace

InterventionThis study examined whether the impacts of sugar taxes and front-of-pack (FOP) nutrition labels differ across socio-demographic subgroups.Research questionWhat are the main and moderating effects of individual-level characteristics on the nutrient content of participants’ purchases in response to varying taxation levels and FOP labels?MethodsData from an experimental marketplace were analyzed. A sample of 3584 Canadians aged 13 years and older received $5 to purchase an item from a selection of 20 beverages and 20 snack foods. Participants were shown products with one of five FOP labels and completed eight within-subject purchasing tasks with different tax conditions. Linear mixed models were used to estimate the main and moderating effects of 11 individual-level variables on the sugars, sodium, saturated fats, and calorie content of participants’ purchases.ResultsParticipants who were younger, male, and more frequent consumers of sugary drinks purchased products containing more sugars, sodium, saturated fats, and calories. Sex and age moderated the relationship between tax condition and sugars or calories purchased: female participants were more responsive than males to a tax that included fruit juice, and younger participants were more responsive to all sugar tax conditions than older participants. Reported thirst and education level also moderated the relationship between tax condition and calories purchased. No individual-level characteristics moderated the effects of FOP labels.ConclusionA small proportion (7 of 176) of the moderating effects tested in this study were significant. Sugar taxes and FOP labelling policies may therefore produce similar effects across key socio-demographic groups.Supplementary InformationThe online version contains supplementary material available at 10.17269/s41997-021-00475-x.     

Regular aerobic exercise increases dispositional mindfulness in men: A randomized controlled trial

Dispositional mindfulness is a construct described as the propensity to be aware of one's actions in everyday life. Although high dispositional mindfulness has been demonstrated to be beneficial for improved mental and physical health, little is known about ways to improve dispositional mindfulness for individuals not practicing meditation or mindful exercises. The study aimed at investigating (1) whether dispositional mindfulness can also be trained by regular aerobic exercise and (2) whether changes in dispositional mindfulness are associated with changes in mental and physical health. 149 healthy men were randomly allocated to one of two 12-week interventions (aerobic exercise or relaxation training) or a waitlist control condition. Dispositional mindfulness and mental and physical health were assessed before and after the intervention by self-report questionnaires. Over the course of the intervention, increases in dispositional mindfulness occurred in the aerobic exercise group but not in the relaxation or waitlist control conditions (p = .018). Increases in dispositional mindfulness were moderately correlated with improvements in mental health. For the first time, this study shows that dispositional mindfulness can be increased through regular aerobic exercise. Future research is needed to identify how the mindfulness-enhancing potential of aerobic exercise can be used most effectively.     

A cluster randomized controlled trial of strategies to increase adolescents' physical activity and motivation in physical education: Results of the Motivating Active Learning in Physical Education (MALP) trial

Objective

Physical education (PE) programs aim to promote physical activity (PA) and reach most school-aged youth. However, PA levels within PE lessons are often low. In this cluster-randomized controlled trial, we examined the effects of three self-determination theory-based motivational strategies on PA and sedentary behavior, as well as their hypothesized antecedents during PE lessons.

Methods

Data were collected in Sydney, Australia (October–December 2011). After baseline testing, teachers (n = 16) and their classes (n = 288 students; M = 13.6 years, 50.4% male) were randomly assigned to one of four teaching strategy conditions: (1) explaining relevance; (2) providing choice; (3) complete free choice; or (4) usual practice. Teachers then delivered the assigned strategy. Primary outcomes were accelerometer-assessed PA and student motivation during lessons. Secondary outcomes included sedentary behavior, perceptions of teachers' support and psychological needs satisfaction.

Results

The ‘free choice’ intervention increased PA (p < .05). ‘Providing choice’ and ‘free choice’ interventions decreased sedentary behavior (p < .05). The interventions did not influence motivation, but students' autonomy increased during both choice-based interventions (p < .05).

Conclusions

Promoting choice can produce short-term increases in PA and decreases in sedentary behavior, as well as increased perceived autonomy during PE lessons.     

真实世界研究与随机对照试验、单病例随机对照试验在临床治疗性研究中的关系比较

真实世界研究、随机对照试验及单病例随机对照试验在设计及具体的实施环节上存在明显不同.随机对照试验属于新治疗措施实施前的研究,真实世界研究属于新治疗措施实施后的研究.两者不是对同一个问题的平行论证,而是承启关系.精心设计的随机对照试验是临床上任何干预措施效果评价的基础,其结果需要真实世界研究的进一步验证及拓展补充,综合考虑二者才是最佳的选择.单病例随机对照试验更易在短时间内获得一些特殊病例的信息,是随机对照试验结果的良好补充,也是一定条件下最经济的真实世界研究.临床工作及其研究是十分复杂的过程.不同个体虽患同种疾病,但临床表现互有差异,且临床反应的变化也不尽相同.因此,无法获得同一干预措施下不同个体的相同治疗效果;加之有的治疗措施缺乏真实性和实用价值,从而使得疗效评价成为一个难题.近些年来,普遍采用试验性的研究结果作为证据指导临床实践活动,其中以随机对照试验(RCT)最为受到重视,但由于RCT属于药物面市前研究,对研究对象的选择、治疗措施的应用等均有严格的限定.     

Mifepristone versus laminaria: a randomized controlled trial of cervical ripening in midtrimester termination

BACKGROUND: Mifepristone was compared with laminaria for cervical ripening in second-trimester induction of labor (IOL). STUDY DESIGN: We performed a randomized, controlled, open-label study of women undergoing second-trimester IOL for fetal demise, aneuploidy or anomalies at a single tertiary care center from January 2004 to May 2006. Main outcome measures were induction-to-delivery time and pain with cervical ripening. RESULTS: Of 50 eligible women, 37 were enrolled in the study, of whom 33 completed the study: 16 were randomized to laminaria and 17 to mifepristone. Induction-to-delivery time was significantly shorter in the mifepristone arm (mean=10 h vs. 16 h, p=.01; median=7.5 h vs. 13.4 h, p=.01). Pain with cervical ripening was also significantly less in the mifepristone group than in the laminaria group (median=1 vs. 6 on an 11-point visual analogue scale, p<.001). Maternal age, parity, gestational age, fetal demise prior to induction, need for postpartum curettage, blood loss, pain during induction, delivery and at the time of discharge were not significantly different between the two groups. CONCLUSION: Mifepristone shortens the induction-to-delivery time and decreases pain with cervical ripening when compared with laminaria for second-trimester induction.     

Intervention to Improve Menstrual Health Among Adolescent Girls Based on the Theory of Planned Behavior in Iran: A Cluster-randomized Controlled Trial

Objectives:Poor menstrual health may lead to school absenteeism and adverse health outcomes for adolescents. The purpose of this study was to determine the effect of pubertal and menstrual health education on health and preventive behaviors among Iranian secondary school girls.Methods:A quasi-experimental study was conducted to evaluate the effectiveness of a health intervention program. A total of 578 students (including intervention and control participants) in 12 schools in Tehran Province, Iran were included by multistage random sampling. The program comprised seven 2-hour educational sessions. After confirming the reliability and validity of a researcher-made questionnaire, that questionnaire was used to collect the required data, and the groups were followed up with after 6 months.Results:After the educational intervention, the mean scores of menstrual health-related knowledge and constructs of the theory of planned behavior were significantly higher in the intervention group than in the control group (p<0.001 for all dimensions).Conclusions:The results of this study emphasize the effectiveness of menstrual health interventions in schools. These findings should also encourage health policy-makers to take committed action to improve performance in schools.     

Computer-assisted cognitive rehabilitation in persons with multiple sclerosis: Results of a multi-site randomized controlled trial with six month follow-up

Background

The effects of multiple sclerosis (MS) on cognition have gained increasing recognition as one of the major disabling symptoms of the disease. Despite the prevalence of these symptoms and their impact on quality of life, limited attention has been given to strategies that might help manage the cognitive changes commonly experienced by persons with MS.

Efficacy and safety of very-low-calorie diet in Taiwanese: A multicenter randomized, controlled trial

ObjectiveVery-low-calorie diets (VLCDs) are an effective method for weight reduction in Caucasians. This study investigated the efficacy and safety of two different VLCDs (450 or 800 kcal/d) in obese Taiwanese.Methods132 participants with BMI ≥30 kg/m² were randomized to two VLCD groups for body weight reduction for 12 weeks. Each group had 66 participants. Anthropometric and metabolic parameters were measured.ResultsThe intention-to-treat analysis revealed that the percentage change in body weight over the 12-week treatment period was –9.14% in the VLCD-450 group and –8.98% in the VLCD-800 group. A total of 27 (40.9%) participants in the VLCD-450 group and 29 (43.9%) participants in the VLCD-800 group achieved 10% or more weight loss at the end of treatment. The body weight, waist circumference, hip circumference, fat mass, blood pressure, triglycerides, and blood glucose were statistically improved from baseline but not between the two groups. The improvement rate of nonalcoholic fatty liver disease (NAFLD) was 41.5% in the VLCD-450 group and 50.0% in the VLCD-800 group. The incidence of adverse events did not differ significantly between the groups and no serious adverse events were reported in either group.ConclusionBoth the VLCD-450 and 800 kcal/d can effectively and safely reduce body weight and improve NAFLD in 12 weeks in obese Taiwanese participants. However, there is no additional benefit in prescribing the more restrictive diet intervention in Taiwanese.     

Randomized trial of a clinic-based, community-supported, lifestyle intervention to improve physical activity and diet: the North Carolina enhanced WISEWOMAN project

OBJECTIVE: To determine if a clinic-based behavioral intervention program for low-income mid-life women that emphasizes use of community resources will increase moderate intensity physical activity (PA) and improve dietary intake. METHODS: Randomized trial conducted from May 2003 to December 2004 at one community health center in Wilmington, NC. A total of 236 women, ages 40-64, were randomized to receive an Enhanced Intervention (EI) or Minimal Intervention (MI). The EI consisted of an intensive phase (6 months) including 2 individual counseling sessions, 3 group sessions, and 3 phone calls from a peer counselor followed by a maintenance phase (6 months) including 1 individual counseling session and 7 monthly peer counselor calls. Both phases included efforts to increase participants' use of community resources that promote positive lifestyle change. The MI consisted of a one-time mailing of pamphlets on diet and PA. Outcomes, measured at 6 and 12 months, included the comparison of moderate intensity PA between study groups as assessed by accelerometer (primary outcome) and questionnaire, and dietary intake assessed by questionnaire and serum carotenoids (6 months only). RESULTS: For accelerometer outcomes, follow-up was 75% at 6 months and 73% at 12 months. Though moderate intensity PA increased in the EI and decreased in the MI, the difference between groups was not statistically significant (p=0.45; multivariate model, p=0.08); however, moderate intensity PA assessed by questionnaire (92% follow-up at 6 months and 75% at 12 months) was greater in the EI (p=0.01; multivariate model, p=0.001). For dietary outcomes, follow-up was 90% for questionnaire and 92% for serum carotenoids at 6 months and 74% for questionnaire at 12 months. Dietary intake improved more in the EI compared to the MI (questionnaire at 6 and 12 months, p<0.001; serum carotenoid index, p=0.05; multivariate model, p=0.03). CONCLUSION: The EI did not improve objectively measured PA, but was associated with improved self-reported and objective measures of dietary intake.     

Immunogenicity and safety of a high-dose hepatitis B vaccine among patients receiving methadone maintenance treatment: A randomized,double-blinded,parallel-controlled trial

Background and aimsTo explore whether the immunization with high-dose (60 μg) hepatitis B vaccines in patients receiving methadone maintenance treatment (MMT) could yield a superior protection against hepatitis B infection than did the standard dose (20 μg).MethodsWe conducted a randomized, double-blinded, parallel-controlled trial in MMT patients. Patients with serologically negative hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) were randomized in a ratio of 1:1 to receive three intramuscular injections of 20 μg or 60 μg recombinant hepatitis B vaccine at months 0, 1, and 6. Serum HBsAg and anti-HBs were measured at months 7 and 12 post-vaccination to assess the immunogenicity.ResultsA total of 196 MMT patients were randomized and 195 received at least one injection (98 and 97 in 20 and 60 μg vaccine groups, respectively). The 60 μg vaccine group showed a seroconversion of anti-HBs of 87.3%, high-level response rate of 56.3%, and GMC of 742.9 mIU/mL at month 7. While these results were numerically higher than the 20 μg group, a statistical difference was not found. HIV infection and concomitant drug abuse were negatively associated with the robust immune responses. 7.7% of MMT patients receiving at least one dose of vaccine reported solicited adverse reactions within 7 days after vaccination, 2.6% reported unsolicited adverse reactions within 28 days after vaccination. None of the MMT patients reported serious adverse events or became HBsAg positive during the follow-up.ConclusionsThe three-dose regimen of 60 μg recombinant hepatitis B vaccine at months 0, 1, and 6 can yield a similar immunogenicity among MMT patients as compared to the 20 μg vaccine.ClinicalTrials.gov identifier: NCT02991599     

The effect of walking and vitamin B supplementation on quality of life in community-dwelling adults with mild cognitive impairment: a randomized,controlled trial

Objectives To examine the effect of walking and vitamin B supplementation on quality-of-life (QoL) in community-dwelling adults with mild cognitive impairment. Methods One year, double-blind, placebo-controlled trial. Participants were randomized to: (1) twice-weekly, group-based, moderate-intensity walking program (n = 77) or a light-intensity placebo activity program (n = 75); and (2) daily vitamin B pills containing 5 mg folic acid, 0.4 mg B12, 50 mg B6 (n = 78) or placebo pills (n = 74). QoL was measured at baseline, after six and 12 months using the population-specific Dementia Quality-of-Life (D-QoL) to assess overall QoL and the generic Short-Form 12 mental and physical component scales (SF12-MCS and SF12-PCS) to assess health-related QoL. Results Baseline levels of QoL were relatively high. Modified intention-to-treat analyses revealed no positive main intervention effect of walking or vitamin supplementation. In both men and women, ratings of D-QoL-belonging and D-QoL-positive affect subscales improved with 0.003 (P = 0.04) and 0.002 points (P = 0.06) with each percent increase in attendance to the walking program. Only in men, SF12-MCS increased with 0.03 points with each percent increase in attendance (P = 0.08). Conclusion Several small but significant improvements in QoL were observed with increasing attendance to the walking program. No effect of vitamin B supplementation was observed. Trial Registration International Standard Randomized Controlled Trial Number Register, 19227688, http://www.controlled-trials.com/isrctn/.     

A randomized trial of electronic reminders showed a reduction in the time to respond to postal questionnaires

Objective

To assess the effect of electronic reminders (ERs) on response rate and time to response for the return of postal questionnaires.

Study Design and Setting

This open randomized controlled trial (RCT) was conducted at the University of York. Participants who were taking part in an established RCT and who provided an electronic mail address and/or mobile telephone number were eligible to take part in the study. The intervention group received ERs on the day they were expected to receive postal questionnaires.

Results

One hundred forty-eight participants (19 male and 129 female) aged 47 ± 11 (range, 19-65) years were studied. About 89.2% of participants returned postal questionnaires. There was no difference in questionnaire response rates in control (64 of 74 [86.5%]) vs. intervention (68 of 74 [91.9%]), groups (relative risk = 1.063, 95% confidence interval: 0.949-1.189). Median questionnaire time to response was 4 days less in the intervention group (10.0 ± 0.2; range, 10-14 days) compared with the control group (14.0 ± 1.4; range, 10-23 days) (χ²_1df = 5.27, P = 0.022).

Conclusion

ERs are useful tools for reducing participant time to response for postal questionnaires. We found little evidence for an effect of ERs on response rate for postal questionnaires.     

Pilot study on the effect of parenteral vitamin E on ischemia and reperfusion induced liver injury: a double blind, randomized, placebo-controlled trial

BACKGROUND AND AIMS: Liver surgery usually involves ischemia and reperfusion (I/R) which results in oxidative stress and cell damage. The administration of antioxidants should diminish or prevent this damage. The purpose of this study was to investigate the effect of the antioxidant vitamin E on I/R injury. METHODS: We carried out a placebo-controlled double-blind study on 68 patients undergoing elective, tumor-related, partial liver resection. 47 patients were qualified for the per protocol population based evaluation. The patients were randomly assigned to two groups. The day before surgery one group received three infusions containing vitamin E (600 IU=540 mg vitamin E emulsion). The other group received three infusions of placebo. RESULTS: Length of stay in the intensive care unit (ICU) was significantly shorter in the verum group than in the placebo group (P<0.05). There were signs of improvement for AUC AST (P<0.05), ALT and GLDH in the verum group after surgery. Serum vitamin E concentration increased after administration of vitamin E infusion and declined in both treatment groups after surgery (P<0.01). In the verum group vitamin E deficiency was prevented while vitamin E concentration remained low in the placebo group (P<0.01). CONCLUSIONS: The findings from this study indicate that preoperative administration of vitamin E is safe and that this treatment may have beneficial effects by reducing the impact of I/R injury in liver surgery.     

Effects of a brief cardiovascular prevention program by a health advisor in primary care; the 'Hartslag Limburg' project, a cluster randomized trial

Objective

To determine in primary care patients at high risk for a cardiovascular event, the effects on biomedical risk factors for and incidence of cardiovascular events, of a brief cardiovascular prevention program executed by a health advisor.

Method

Design: cluster randomized controlled trial with 1275 patients (24 general practices) in and around Maastricht, the Netherlands (1999–2004).Intervention: health advisors were to complete computerized cardiovascular risk profiles, provide multi-factorial tailored health education and advice, and communicate with GP's to optimize treatment.Outcome: differences in changes in risk factors between baseline and follow up at 6, 18, and 36 months and incidence of cardiovascular events at 36 months.

Results

Process: Because of logistic reasons risk profiles were put on paper instead of in the computerized patient files. On average patients attended 2.3 counseling sessions. Interaction with GPs was less productive than expected. Outcome: Effect after six months on BMI (− 0.20 kg/m² (95% CI − 0.38 to − 0.01, p = 0.039), Cohen's d: −0.18), and after 18 months on HDL-cholesterol (+ 0.05 mmol/l (95% CI + 0.01 to + 0.09, p = 0.014), Cohen's d: 0.14). No other (subgroup) effects were found.

Conclusion

Given the lack of clinically meaningful effects, implementation of this intervention in its present form is not justified.     

Blood and urine mercury levels in adult amalgam patients of a randomized controlled trial: interaction of Hg species in erythrocytes

Parts of the population are permanently exposed to low levels of Hg degrees and Hg(II) from dental amalgam. It was the aim (1) to investigate the internal exposure to amalgam-related mercury from the kinetics of inorganic Hg in plasma and erythrocytes after amalgam removal, and (2) to estimate the amalgam-related absorbed dose. Dietary coexposure was monitored by determination of blood organic-Hg. Postremoval steady-state Hg concentrations were measured for 18 months. Eighty-two patients had been randomized into three groups: (A) removal of the fillings; (B) removal and non-specific detoxification, and (C) a health promotion program without removal. After amalgam removal, inorganic Hg dropped rapidly in plasma and red cells, stabilizing at 27% of preremoval levels after 60 days. Concentrations of organic Hg in plasma remained unchanged, indicating no change in dietary uptake of organic Hg. The concentration of organic Hg in red cells of group A was in the early postremoval phase lower and in the late postremoval phase higher than the preremoval control (p<0.01 for low-high difference). A protracted increase in organic Hg was also found in red cells of group B after 60 days. Thus, the effect of removal on organic Hg levels in the combined group A+B was compared with the values of group C in a linear mixed effects (LME) model which showed a significant increase with time in group A+B (p=0.028). In all groups, time profiles of urinary concentration and excretion of total-Hg were very similar to those of inorganic-Hg levels in plasma. From extrapolations of blood and urine data it was estimated that the amalgam-related inhalation and ingestion of Hg species were within the limits proposed by WHO, ATSDR and EPA. The integrated daily Hg dose absorbed from amalgam was estimated up to 3 microg for an average number of fillings and at 7.4 for a high amalgam load. CONCLUSIONS: This is the first study on adult amalgam patients which continuously monitored the postremoval decline of inorganic Hg and the coexposure from dietary organic Hg in a randomized-controlled-trial design. The integrated daily dose of 7.4 microg absorbed from a high amalgam load is well below the tolerable dose of 30 microg (WHO, 1990). The unexpected postremoval increase in erythrocyte organic Hg, which is associated with the depletion of cellular inorganic Hg, might result from binding of organic Hg to cellular sites previously occupied by inorganic Hg.