Active Women over 50. Promoting Physical Activity in Women Over 50: A Randomized Trial

Purpose This study aims to test the effect of an information and support intervention on physical activity (PA) in women aged 50+ years. Design Randomized wait-list controlled trial. Setting Sydney, Australia. Sample 126 female university and health service employees, aged 50+. Intervention Information session, activity tracker, regular motivational emails. Measures Proportion achieving ≥ 10,000 steps/day (primary outcome), daily step count, proportion meeting 150 mins/week of moderate to vigorous PA (MVPA), self-reported PA. Analysis Odds-ratios and general linear regression models. Results At 3 months, the intervention group reported significantly more vigorous PA (1.04 hours, 95% CI 0.24 to 1.85, P = .01, measured by IPAQ), were more likely to achieve 300 mins/week of MVPA (OR = 1.98, 95% CI 0.89 to 4.36, P = .09, measured by Actigraph) than the control wait-list group, and reported adopting PA promotion strategies (technology = 31/58% or goal-setting = 39/74%). No significant between-group differences in the primary outcome were detected (1.39, 95% CI 0.61 to 3.18, P = .44). Conclusions This low-dose intervention significantly increased self-reported vigorous PA time and non-significantly increased the proportion of people achieving 300 mins/week of MVPA but did not significantly increase the proportion of participants achieving 10,000 steps/day. Relatively small effects may be important at a population level given the minimal resources needed to deliver this intervention.

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The Norwegian Healthy Life Centre Study: A pragmatic RCT of physical activity in primary care

Scandinavian Journal of Public Health ◽

10.1177/1403494818785260 ◽

2018 ◽

Vol 47 (1) ◽

pp. 18-27 ◽

Cited By ~ 8

Author(s):

Gro Beate Samdal ◽

Eivind Meland ◽

Geir Egil Eide ◽

Sveinung Berntsen ◽

Eirik Abildsnes ◽

...

Keyword(s):

Physical Activity ◽

Behaviour Change ◽

Controlled Trial ◽

Intervention Group ◽

Population Level ◽

Drop Out ◽

Healthy Life ◽

Level Of Education ◽

Behaviour Change Interventions ◽

Individual Level

Aims: The aim of this study was to evaluate the effect of behaviour change interventions at Norwegian Healthy Life Centres (HLCs) on participants’ moderate to vigorous intensity physical activity (MVPA) six months after baseline. We also explore predictors of change in MVPA, and if level of education and MVPA at baseline modify the effect. Methods: A randomised controlled trial with inclusion criteria age ⩾ 18 years and ability to participate in group-based physical activity. Participants were randomised to either behaviour change interventions or a waiting list (control). Objective recordings of physical activity were the main outcome, analysed with simple and multiple linear regression. Results: We recruited 118 participants from six HLCs. Participants with mental, musculoskeletal, or chronic somatic disease were more likely to drop out. We revealed no differences in MVPA or sedentary time between the groups. Types of motivation or several characteristics of disadvantage at baseline could not explain changes in MVPA. Across both groups, 83% achieved the recommended 150 minutes of MVPA per week, and participants with a lower level of education were less likely to improve. Participants in the intervention group who were least active at baseline significantly increased their MVPA. Conclusions: The study revealed that the intervention had no short-term effect on time spent on MVPA or sedentary. This study does not support a strong emphasis on behaviour change on an individual level as a way of targeting general health and risk reduction at a population level. Although less active people benefitted more from the HLC intervention, the intervention was unable to counteract widening of inequity across educational groups.

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Increasing Physical Activity in Persons With Dementia: A Randomized Controlled Trial

Journal of Aging and Physical Activity ◽

10.1123/japa.2019-0183 ◽

2020 ◽

Vol 28 (4) ◽

pp. 588-597

Author(s):

Rebekka Pomiersky ◽

Bastian Abel ◽

Christian Werner ◽

André Lacroix ◽

Klaus Pfeiffer ◽

...

Keyword(s):

Physical Activity ◽

Intervention Program ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

The Elderly ◽

Control Group ◽

Moderate Dementia ◽

Activity Questionnaire

This study investigated the effectivity and sustainability of a physical activity (PA) promotion and motor training programs and analyzed predictors for PA changes in persons with dementia. A total of 122 participants with mild-to-moderate dementia were randomized to the intervention program designed for persons with dementia (intervention group) or a motor placebo activity (control group). The primary outcome was the Physical Activity Questionnaire for the Elderly assessed at the baseline, after the 3-month intervention, and at a 3-month follow-up. The PA promotion program significantly increased PA in the intervention group compared with the control group during the training intervention phase. Both groups showed an increase in habitual PA when intervention-induced activities were excluded. PA was sustainably increased in both groups at follow-up. Low baseline PA was predictive for increased PA after the intervention and low baseline PA, high motor performance, and low comorbidity for increased PA at follow-up.

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Chemical, Mechanical, and Heat Cleaning to Decontaminate Hospital Drains Harboring Carbapenemase-Producing Enterobacteriales

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2020.1141 ◽

2020 ◽

Vol 41 (S1) ◽

pp. s466-s467

Author(s):

Alainna Juliette Jamal ◽

Rajni Pantelidis ◽

Rachael Sawicki ◽

Angel Li ◽

Wayne Chiu ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Group Versus ◽

Brain Heart Infusion ◽

Standard Of Care ◽

Rt Pcr ◽

Comparator Group ◽

Carbapenemase Gene ◽

Cleaning Intervention

Background: Carbapenemase-producing Enterobacteriales (CPE) outbreaks have been linked to contaminated wastewater drainage systems in hospitals. The optimal strategy for CPE decontamination of drains is unknown. In this randomized controlled trial, we aimed to determine whether combining chemical, mechanical, and heat cleaning was superior to routine cleaning for drain decontamination. Methods: We enrolled CPE-contaminated hospital drains at 2 geographic locations. Eligible drains were those initially found to be culture positive in a 2017 study and that remained positive (by RT-PCR) when retested twice in August 2018. Drains were stratified by type (sink versus shower) and randomized with a 1:1 allocation ratio (as per computer-generated randomization) to standard-of-care cleaning (comparator) or combined chemical, mechanical, and heat cleaning (intervention) on day 0. Drain tail pieces were swabbed on days 0 (before administration of the intervention), 1, 2, 3, 7, and 14, and at months 1, 2, 3, 4, 5, and 6. Swabs were placed into brain heart infusion with 10% Dey-Engley neutralizing broth and incubated overnight. Direct RT-PCR was performed to detect KPC, VIM, NDM, OXA-48–like, IMP, GES, and SME genes. The primary outcome was drain decontamination, defined as no detectable carbapenemase gene in the drain from day 1 to 7 (inclusive). Results: Overall, 33 CPE-contaminated drains were enrolled (7 sink and 26 shower); 17 and 16 drains were randomized to the intervention and comparator, respectively. Moreover, 12 (36%) drains met the primary outcome of decontamination, 18 (55%) remained contaminated, and 3 (9%) could not be assessed. Among drains that could be assessed, 11 of 15 (74%) in the intervention group met the primary outcome of decontamination compared to 1 of 15 (7%) in the comparator group (P = .0005). Of the 11 drains in the intervention group that were decontaminated, the carbapenemase gene present at enrollment was subsequently detected in 10 (91%): 1 (10%) at day 14, 3 (30%) at month 1, 4 (40%) at month 3, 1 (10%) at month 4, and 1 (10%) at month 6. The median time to a swab yielding CPE was 1 day in the comparator group versus 14 days in the intervention group (Fig. 1). Overall, 24 drains (73%) had a carbapenemase gene (that was not detectable at enrollment) appear in the follow-up. Of patients identified as CPE colonized or infected during this study, none occupied rooms with these drains. Conclusions: Chemical, mechanical, and heat cleaning were superior to standard cleaning for CPE decontamination of hospital drains at 7 days, but these trends were not sustained. Such cleaning may be useful if applied repeatedly.Funding: NoneDisclosures: Allison McGeer reports funds to her institution for studies for which she is the principal investigator from Pfizer and Merck as well as consulting fees from Sanofi-Pasteur, Sunovion, GSK, Pfizer, and Cidara.

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Anthropometric Variables as Mediators of the Association of Changes in Diet and Physical Activity With Inflammatory Profile

The Journals of Gerontology Series A ◽

10.1093/gerona/glab072 ◽

2021 ◽

Author(s):

Gabriela Cárdenas-Fuentes ◽

Camille Lassale ◽

Miguel Ángel Martínez-González ◽

María Grau ◽

Jordi Salas-Salvadó ◽

...

Keyword(s):

Physical Activity ◽

Body Mass Index ◽

Body Mass ◽

Body Fat ◽

Controlled Trial ◽

High Sensitivity ◽

Linear Regression Models ◽

Mediating Role ◽

Inflammatory Score ◽

Inflammatory Profile

Abstract Background Mechanisms underlying the associations of high levels of physical activity (PA) and adherence to the Mediterranean diet (MedDiet) with a better inflammatory profile remain unclear. Our objective was to assess the mediating role of changes in body mass index (BMI) and waist circumference (WC), as markers of body fat in the association of changes in PA and adherence to the MedDiet, with changes in the inflammatory profile. Method This study included 489 adults, aged 55–75 years, from the PREDIMED-Plus multicenter lifestyle intervention trial. An inflammatory score was calculated, based on 8 blood biomarkers: high-sensitivity C-reactive protein, interleukin 6, interleukin 8, interleukin 18, monocyte chemo-attractant protein-1, C-peptide, leptin, and regulated on activation, normal T-cell–expressed and secreted chemokine. Biomarkers, levels of PA, score of MedDiet adherence, BMI, and WC were measured at baseline and at 1-year follow-up. Linear regression models were fitted according to the Baron and Kenny framework for mediation analysis. Results Changes in BMI and WC mediated the association of both changes in PA and changes in the MedDiet adherence with the inflammatory score. Body mass index mediated 26% of the association of changes in total PA with the inflammatory profile, and 27% of the association of changes in the MedDiet, while WC mediated 13% and 12% of these associations, respectively. Conclusion In older adults at high cardiovascular risk, increasing PA levels and adherence to a MedDiet during 1 year were associated with a lower inflammatory score, which was partly mediated by a reduction in body fat. Clinical Trials Registration Number International Standard Randomized Controlled Trial Number: ISRCTN89898870; registration date July 24, 2014, retrospectively registered.

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Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

Clinical Oral Investigations ◽

10.1007/s00784-021-03908-6 ◽

2021 ◽

Author(s):

K. Wernicke ◽

J. Grischke ◽

M. Stiesch ◽

S. Zeissler ◽

K. Krüger ◽

...

Keyword(s):

Physical Activity ◽

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Periodontal Health ◽

Randomized Controlled ◽

Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

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Effects of an interprofessional Quality Circle-Deprescribing Module (QC-DeMo) in Swiss nursing homes: a randomised controlled trial

BMC Geriatrics ◽

10.1186/s12877-021-02220-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Damien Cateau ◽

Pierluigi Ballabeni ◽

Anne Niquille

Keyword(s):

Nursing Homes ◽

Controlled Trial ◽

Intervention Group ◽

Defined Daily Dose ◽

Potentially Inappropriate Medications ◽

Quality Circle ◽

Linear Regression Models ◽

Physical Restraints ◽

Strong Trend

Abstract Background Potentially inappropriate medications (PIMs) are common among nursing homes (NH) residents, as is polypharmacy. Deprescribing has emerged in the past decade as a safe and effective way to reduce the use of PIMs and improve patient outcomes. However, effective deprescribing interventions are expensive, as they require specialised staff and a great amount of time for each resident. The Quality Circle Deprescribing Module (QC-DeMo) intervention was designed to be less resource-intensive than medication reviews, the current deprescribing gold standard. It consists of a QC session in which physicians, nurses, and pharmacists define a local deprescribing consensus for specific PIMs classes, which is then implemented in the NH. The intervention was trialled in a RCT, with the NH as unit of analysis. Methods After randomisation, intervention NHs enacted the QC-DeMo at the start of the follow-up year. The primary outcomes were the proportion of PIM galenic units and number of PIM defined daily dose per average resident and per day (DDD/res). PIM status was assessed by a combination of the 2015 Beers list and the Norwegian General Practice-Nursing Home criteria. Secondary outcomes were the number of DDD/res to avoid and to reevaluate; safety outcomes were mortality, hospitalisations, falls, and use of physical restraints. Outcomes were evaluated at follow-up using linear regression models, adjusting for the outcome baseline values. Results Fifty-eight NHs took part in the trial; no individual residents were recruited. The intervention did not reduce the primary outcomes, but a strong trend towards reduction was seen for the number of PIM DDD/res, which accounts for the doses used. PIM DDD/res to reevaluate were significantly reduced, mostly through a reduction in the use of proton-pump inhibitors. Falls and use of physical restraints were not affected, but a statistical interaction between the mission of the NH (geriatric unit or specialised dementia unit) and the intervention group was seen for mortality and hospitalisations. Conclusions The QC-DeMo intervention can reduce the use of some PIM classes, and could usefully complement other deprescribing interventions. Trial registration ClinicalTrials.gov (NCT03688542), registered on 26.09.2018, retrospectively registered.

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Efficacy of a Multi-Component m-Health Diet, Physical Activity, and Sleep Intervention on Dietary Intake in Adults with Overweight and Obesity: A Randomised Controlled Trial

Nutrients ◽

10.3390/nu13072468 ◽

2021 ◽

Vol 13 (7) ◽

pp. 2468

Author(s):

Sasha Fenton ◽

Tracy L. Burrows ◽

Clare E. Collins ◽

Anna T. Rayward ◽

Beatrice Murawski ◽

...

Keyword(s):

Physical Activity ◽

Weight Loss ◽

Randomised Controlled Trial ◽

Dietary Intake ◽

Controlled Trial ◽

Intervention Group ◽

Weight Loss Intervention ◽

Traditional Group ◽

Traditional Diet ◽

Randomised Controlled

This three-arm randomised controlled trial evaluated whether (1) a multi-component weight loss intervention targeting diet, physical activity (PA), and sleep was effective at improving dietary intake over six months and 12 months, compared with a control, and (2) the enhanced diet, PA, and sleep intervention was more effective at improving dietary intake than the traditional diet and PA intervention. A total of 116 adults (70% female, 44.5 years, BMI 31.7 kg/m2) were randomised to either traditional diet and PA intervention; enhanced diet, PA, and sleep intervention; or wait-list control. To examine between-group differences, intervention groups were pooled and compared with the control. Then, the two intervention groups were compared. At six months, the pooled intervention group consumed 1011 fewer kilojoules/day (95% CI −1922, −101), less sodium (−313.2 mg/day; 95% CI −591.3, −35.0), and higher %EI from fruit (+2.1%EI; 95% CI 0.1, 4.1) than the controls. There were no differences in intake between the enhanced and traditional groups at six months. At 12 months, the pooled intervention and control groups reported no significant differences. However, compared to the traditional group, the enhanced reported higher %EI from nutrient-dense foods (+7.4%EI; 95% CI 1.3, 13.5) and protein (+2.4%EI; 95% CI 0.1, 4.6), and reduced %EI from fried/takeaway foods (−3.6%EI; 95% CI −6.5, −0.7), baked sweet products (−2.0%EI; 95% CI −3.6, −0.4), and packaged snacks (−1.1%EI; 95% CI −2.2, −0.3). This weight loss intervention reduced total energy and sodium intakes as well as increased fruit intake in adults at six months. The enhanced intervention group reported improved dietary intake relative to the traditional group at 12 months.

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DigiKnowIt News: Educating youth about pediatric clinical trials using an interactive, multimedia educational website

Journal of Child Health Care ◽

10.1177/13674935211003774 ◽

2021 ◽

pp. 136749352110037

Author(s):

Alison E. Parker ◽

Tracy M. Scull ◽

Abigail M. Morrison

Keyword(s):

Clinical Trials ◽

Interactive Multimedia ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Wait List ◽

Wait List Control Group ◽

Wait List Control ◽

Satisfaction Questionnaire ◽

Study Participants

Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News, an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News. The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.

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Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-021-01133-8 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Russell Jago ◽

Byron Tibbitts ◽

Kathryn Willis ◽

Emily Sanderson ◽

Rebecca Kandiyali ◽

...

Keyword(s):

Physical Activity ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Cluster Randomised ◽

Secondary Outcomes ◽

Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

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Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol

BMJ Open ◽

10.1136/bmjopen-2018-026086 ◽

2019 ◽

Vol 9 (6) ◽

pp. e026086

Author(s):

Yasutake Tomata ◽

Fumiya Tanji ◽

Dieta Nurrika ◽

Yingxu Liu ◽

Saho Abe ◽

...

Keyword(s):

Financial Incentives ◽

Primary Outcome ◽

Financial Incentive ◽

Controlled Trial ◽

Intervention Group ◽

Sample Size Calculation ◽

Community Dwelling ◽

Control Group ◽

Modifiable Factors ◽

Randomised Controlled

IntroductionPhysical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan.Methods and analysisThis study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4–6 weeks and 7–9 weeks) relative to the average number of daily steps at the baseline (1–3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps.Ethics and disseminationThis study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal.Trial registration numberUMIN000033276; Pre-results.

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