Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

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Equol effects on AGE skin products, visceral fat and climacteric symptoms in post-menopausal women: A randomized controlled trial

10.21203/rs.3.rs-265906/v2 ◽

2021 ◽

Author(s):

Remi Yoshikata ◽

Khin Zay Yar Myint ◽

Hiroaki Ohta ◽

Yoko Ishigaki

Keyword(s):

Randomized Controlled Trial ◽

Visceral Fat ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Climacteric Symptoms ◽

Post Intervention ◽

Randomized Controlled ◽

Menopausal Women ◽

Post Menopausal

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered as a potentially effective agent for relieving climacteric symptoms, for the prevention of the lifestyle-related diseases, and for aging care in post-menopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging, and climacteric symptoms, with respect to internally-produced equol in post-menopausal women.Methods: A single center, randomized controlled trial (registration number: UMIN000030975) on 57 post-menopausal Japanese women (mean age: 56±5.37 years), was conducted. Twenty-seven women received the equol supplement, while the remaining received Control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese post-menopausal women. Results: Three months post intervention, the treatment group showed significant improvement in climacteric symptoms, when compared to the Control group (81% vs. 53% respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations significant improvement in skin auto-fluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. Conclusion: Women receiving equol supplement showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously-produced equol to improve skin aging and visceral fat in certain populations.

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Pharmacist-led counselling intervention to improve antiretroviral drug adherence in Pakistan: a randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-020-05571-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Zeenat Fatima Chatha ◽

Usman Rashid ◽

Sharon Olsen ◽

Fakhar ud Din ◽

Amjad Khan ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Intervention Group ◽

Care Group ◽

People Living With Hiv ◽

Post Intervention ◽

Randomized Controlled ◽

Cell Counts ◽

Cd4 Cell

Abstract Background Pakistan is facing a growing population of people living with human immunodeficiency (HIV). In this randomized controlled trial, we investigate if a pharmacist-led intervention can increase adherence to antiretroviral therapy (ART) for people living with HIV (PLWH). Methods Adults with HIV, who have been taking ART for more than 3 months were randomly assigned to receive either a pharmacist-led intervention or their usual care. Measures of adherence were collected at 1) baseline 2) just prior to delivery of intervention and 3) 8 weeks later. The primary outcomes were CD4 cell count and self-reported adherence measured with the AIDS Clinical Trial Group (ACTG) questionnaire. Results Post-intervention, the intervention group showed a statistically significant increase in CD4 cell counts as compared to the usual care group (p = 0.0054). In addition, adherence improved in the intervention group, with participants being 5.96 times more likely to report having not missed their medication for longer periods of time (p = 0.0086) while participants in the intervention group were 7.74 times more likely to report missing their ART less frequently (p < 0.0001). Conclusions The findings support the improvement in ART adherence and HIV management. Trial registration The trial is registered with Australian New Zealand Clinical Trials Registry (ACTRN12618001882213). Registered 20 November 2018.

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The impact of an empowerment intervention on people with schizophrenia: Results of a randomized controlled trial

International Journal of Social Psychiatry ◽

10.1177/0020764017693652 ◽

2017 ◽

Vol 63 (3) ◽

pp. 212-223 ◽

Cited By ~ 7

Author(s):

Abdalhadi Hasan ◽

Mahmoud Musleh

Keyword(s):

Randomized Controlled Trial ◽

Psychiatric Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Post Intervention ◽

Treatment As Usual ◽

Randomized Controlled ◽

Secondary Outcomes ◽

The Impact

Aims: The aim of the study was to assess what empowerment intervention has on people with schizophrenia. Methods: A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks’ worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. Results: This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. Conclusion: This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.

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Effectiveness of Yijinjing on Cognitive Functions in Post-stroke Patients With Mild Cognitive Impairment: Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-204458/v1 ◽

2021 ◽

Author(s):

Xin Xue ◽

Xue-Xing Jin ◽

Kai-Liang Luo ◽

Xin-Hao Liu ◽

Li Zhang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Functions ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Stroke Patients ◽

Post Stroke ◽

Randomized Controlled

Abstract Background: Statistics show that every year, 5.4 million people in the world suffer a stroke. Post-stroke cognitive impairment (PSCI) is one of the most common complications after stroke with a rate of 75%, which leads to decreased functions for independent living and reduced quality of life (QOL). Exercise training has been reported to be useful to improve the cognitive functions of post-stroke patients. Yijinjing, a traditional Chinese Qigong exercise characterized by an integration of mind and body in moderate exercise intensity, can improve cognitive functions of PSCI patients. This study aims to explore the feasibility and effectiveness of the Yijinjing exercise in this regard.Methods: A single-blind, randomized controlled trial will be employed with evaluations at three and six months. 72 PSCI patients will be recruited and randomly assigned to the Yijinjing exercise intervention group or the control group (1:1). Participants in the control group will receive routine rehabilitation therapies, including occupational therapy, physical therapy, acupuncture therapy, and health education 5 times a week for 3 months. The intervention group will receive a 12-week routine rehabilitation therapy combined with the Yijinjing exercise intervention for 40 minutes each session and 3 sessions a week. The primary outcome of cognition will be measured by the Montreal Cognitive Assessment scale (MoCA). Secondary outcomes include executive function, memory function, visuospatial function, sleep quality, gait and motor function, activity of daily living (ADL), and quality of life (QOL).Discussion: Current evidence has reported the effectiveness of traditional Chinese exercise in improving the post-stroke population’s motor functions. This research is a randomized controlled trial that evaluates traditional Chinese exercise’s effectiveness for PSCI patients. It is expected to expand the traditional Chinese exercise scope and provide a new treatment approach for stroke populations with cognitive impairments.Trail registration: Chinese Clinical Trial Registry, ChiCTR1900026532. Registered on 13 October 2019.

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Evaluation of My Stress Control, a web-based stress management program for persons experiencing work-related stress: A randomized controlled trial (Preprint)

10.2196/preprints.17314 ◽

2019 ◽

Author(s):

Caroline Eklund ◽

Anne Söderlund ◽

Magnus L Elfström

Keyword(s):

Randomized Controlled Trial ◽

Stress Management ◽

Perceived Stress ◽

Controlled Trial ◽

Intervention Group ◽

Wait List ◽

Post Intervention ◽

Web Based ◽

Stress Control ◽

Randomized Controlled

BACKGROUND Stress is one of the most common reasons for sick leave. Web-based interventions have the potential to reach an unlimited number of users at a low cost and have been shown effective at addressing several health-related problems. To handle stress on an individual level is about behavior change. To support behavior change in stress management My Stress Control (MSC) was developed. The development of MSC was based on several health psychology theories and models but central in the development was Social Cognitive Theory, Theory of Reasoned Action, Theory of Planned Behavior, Transactional Theory of Stress and Coping and the Transtheoretical Model and Stages of Change. MSC is a fully automated program. The program is tailored to the user's specific need for stress management and behavior change. OBJECTIVE The aim of this study was to conduct a randomized controlled trial to evaluate the extent to which MSC affected perceived stress in persons experiencing work-related stress. METHODS This study was conducted as a randomized controlled trial with two arms. Study participants were recruited by visiting worksites and workplace meetings. Participants were assigned to intervention or wait list group. Web-based questionnaires were used pre- and post-intervention to collect data. Perceived stress measured with the Perceived Stress Scale (PSS-14) was the primary outcome measurement. Analyses were conducted for both between- and within-group changes. RESULTS A total of 92 participants were included in this study, 48 in intervention group and 44 in waitlist group. Twelve participants in the intervention group and 19 participants in the waitlist group completed the post intervention assessment. There were no significant effects on perceived stress between the intervention and wait list groups or within the groups. A small effect size (dCohen=0.25) was found when comparing mean change over time on the primary outcome measure between the intervention and wait list groups. Additionally, a small effect size was found between pre- and post-intervention assessment within the intervention group (dCohen=0.38) as well as within the wait list group (dCohen=0.25). CONCLUSIONS It is still uncertain what effect My Stress Control (MSC) may have on perceived stress. Because adherence was low in the intervention group, elements or features that facilitate adherence must be further developed before firmer conclusions of the effect of MSC can be studied. CLINICALTRIAL This RCT was registered at clinicaltrials.gov, protocol record 2015/0646.

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Enhancing adoptive parenting: A randomized controlled trial

Clinical Child Psychology and Psychiatry ◽

10.1177/1359104510365041 ◽

2010 ◽

Vol 15 (4) ◽

pp. 529-542 ◽

Cited By ~ 22

Author(s):

Alan Rushton ◽

Elizabeth Monck ◽

Morven Leese ◽

Paul McCrone ◽

Jessica Sharac

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Adoptive Parents ◽

Control Group ◽

Parenting Interventions ◽

Post Intervention ◽

Randomized Controlled ◽

Significant Difference

The aim was to conduct a pragmatic randomized controlled trial (RCT) to evaluate two parenting programmes designed for adopters of children late placed from care. Adoptive parents, with children between 3 and 8 years who were screened to have serious behavioural problems early in the placement, participated in home-based, manualized, parenting programmes delivered by trained and supervised family social workers. The adopters who agreed to join the study were randomly allocated to one of two parenting interventions or to a “services as usual” group. Baseline, immediate post-intervention and six-month follow-ups were assessed using questionnaires and adopter interviews. No cases were lost to follow-up at any point and satisfaction was high with both parenting interventions. At the six-month follow-up, a significant difference ( p < 0.007) was found for “satisfaction with parenting” in favour of the intervention group (Effect Size d = 0.7). Negative parenting approaches were reduced in the intervention group. However, no significant differences in child problems were found between the intervention groups and control group, adjusting for baseline scores. Costs analysis showed that a relatively modest investment in post-adoption support would be well spent in improving adopters’ satisfaction with parenting in the intervention group compared to the routine service group.

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Effectiveness of Yijinjing on cognitive functions in post-stroke patients with mild cognitive impairment: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05220-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xin Xue ◽

Xue-Ming Jin ◽

Kai-Liang Luo ◽

Xin-Hao Liu ◽

Li Zhang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Functions ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Stroke Patients ◽

Post Stroke ◽

Randomized Controlled

Abstract Background Statistics show that every year, 5.4 million people in the world suffer a stroke. Post-stroke cognitive impairment (PSCI) is one of the most common complications after stroke with a rate of 75%, which leads to decreased functions for independent living and reduced quality of life (QOL). Exercise training has been reported to be useful to improve the cognitive functions of post-stroke patients. Yijinjing, a traditional Chinese Qigong exercise characterized by an integration of mind and body in moderate exercise intensity, can improve cognitive functions of PSCI patients. This study aims to explore the feasibility and effectiveness of the Yijinjing exercise in this regard. Methods A single-blind, superiority, randomized controlled trial will be employed with evaluations at 3 and 6 months. Seventy-two PSCI patients will be recruited and randomly assigned to the Yijinjing exercise intervention group or the control group (1:1). Participants in the control group will receive routine rehabilitation therapies, including occupational therapy, physical therapy, acupuncture therapy, and health education 5 times a week for 3 months. The intervention group will receive a 12-week routine rehabilitation therapy combined with the Yijinjing exercise intervention for 40 min each session and 3 sessions a week. The primary outcome of cognition will be measured by the Montreal Cognitive Assessment scale (MoCA). Secondary outcomes include executive function, memory function, visuospatial function, sleep quality, gait and motor function, activity of daily living (ADL), and quality of life (QOL). Discussion Current evidence has reported the effectiveness of traditional Chinese exercise in improving the post-stroke population’s motor functions. This research is a randomized controlled trial that evaluates traditional Chinese exercise’s effectiveness for PSCI patients. It is expected to expand the traditional Chinese exercise scope and provide a new treatment approach for stroke populations with cognitive impairments. Trial registration Chinese Clinical Trial Registry ChiCTR1900026532. Registered on 13 October 2019.

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Weekly group tummy time classes are feasible and acceptable to mothers with infants: a pilot cluster randomized controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-020-00695-x ◽

2020 ◽

Vol 6 (1) ◽

Author(s):

Lyndel Hewitt ◽

Samantha Stephens ◽

Abbe Spencer ◽

Rebecca M. Stanley ◽

Anthony D. Okely

Keyword(s):

Randomized Controlled Trial ◽

Motor Development ◽

Group Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Time Duration ◽

Randomized Controlled ◽

Tummy Time

Abstract Background The World Health Organization recommends 30 min of tummy time daily for improved motor development and reduced likelihood of plagiocephaly. As only 30% of infants meet this recommendation, parents require strategies and support to increase this proportion. Methods The aim of this study was to determine the feasibility, acceptability, and potential efficacy of a group intervention to promote tummy time. The design is a cluster randomized controlled trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Five groups of healthy infants (N = 35, baseline mean (SD) age 5.9 (2.8) weeks) and their mothers attending local mother’s groups (Australia) were randomly allocated to the intervention or control group. The intervention group received group tummy time classes in addition to usual care. The control group received usual care with their child and family health nurse. Primary outcomes were intervention feasibility and acceptability. Secondary outcomes were tummy time duration (accelerometry), adherence to physical activity guidelines, head shape, and motor development. Measures were taken at baseline, post-intervention, and when infants were 6 months of age. Analyses were by linear mixed models and Cohen’s d statistic. Results Recruitment, retention, and collection of objective data met feasibility targets. Acceptability was also met with intervention mothers reporting the information, goal planning, and handouts significantly more useful and relevant than control group mothers (p < 0.01). Moderate effect sizes were also found at post-intervention for tummy time duration, adherence to physical activity guidelines and infant ability in prone and supine favoring the intervention group (intervention infants had a mean of 30 min and 30% adherence to guidelines (95% CI 0 to 60.6 min) compared to the control infants who had a mean of 16.6 min and 13% adherence to the guidelines (95% CI 0 to 42.1 min, Cohen’s d = 0.5). Limitations were the small sample size, 4-week intervention, limited accelerometer use, and a homogenous sample of participants. Conclusion Group tummy time classes delivered in a mother’s group setting were shown to be feasible and acceptable. A larger randomized controlled trial is warranted. Trial registration ANZCTR, ACTRN12617001298303p. Registered 11 September 2017

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The Effects of Exercise Duration and Intensity on Breast Cancer-Related DNA Methylation: A Randomized Controlled Trial

Cancers ◽

10.3390/cancers13164128 ◽

2021 ◽

Vol 13 (16) ◽

pp. 4128

Author(s):

Arielle S. Gillman ◽

Timothy Helmuth ◽

Claire E. Koljack ◽

Kent E. Hutchison ◽

Wendy M. Kohrt ◽

...

Keyword(s):

Breast Cancer ◽

Dna Methylation ◽

Randomized Controlled Trial ◽

Aerobic Exercise ◽

Exercise Intervention ◽

Controlled Trial ◽

Post Intervention ◽

Randomized Controlled ◽

Supervised Exercise

Emerging research suggests that one mechanism through which physical activity may decrease cancer risk is through its influence on the methylation of genes associated with cancer. The purpose of the current study was to prospectively test, using a rigorous experimental design, whether aerobic exercise affects DNA methylation in genes associated with breast cancer, as well as whether quantity of exercise completed affects change in DNA methylation in a dose–response manner. 276 women (M age = 37.25, SD = 4.64) were recruited from the Denver metro area for a randomized controlled trial in which participants were assigned to a supervised aerobic exercise program varying in a fully crossed design by intensity (55–65% versus 75–85% of VO2max) and duration (40 versus 20 min per session). DNA methylation was assessed via blood samples provided at baseline, after completing a 16-week supervised exercise intervention, and six months after the intervention. 137 participants completed the intervention, and 81 had viable pre-post methylation data. Contrary to our hypotheses, total exercise volume completed in kcal/kg/week was not associated with methylation from baseline to post-intervention for any of the genes of interest. An increase in VO2max over the course of the intervention, however, was associated with decreased post-intervention methylation of BRCA1, p = 0.01. Higher levels of self-reported exercise during the follow-up period were associated with lower levels of GALNT9 methylation at the six-month follow-up. This study provides hypothesis-generating evidence that increased exercise behavior and or increased fitness might affect methylation of some genes associated with breast cancer to reduce risk.

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The Effect of an Exercise Intervention on Gestational Weight Gain: The Behaviors Affecting Baby and You (B.A.B.Y.) Study: A Randomized Controlled Trial

American Journal of Health Promotion ◽

10.1177/0890117117732409 ◽

2017 ◽

Vol 32 (3) ◽

pp. 736-744 ◽

Cited By ~ 4

Author(s):

Carrie Nobles ◽

Bess H. Marcus ◽

Edward J. Stanek ◽

Barry Braun ◽

Brian W. Whitcomb ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Weight Gain ◽

Gestational Weight Gain ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Ethnically Diverse ◽

Gestational Weight ◽

Randomized Controlled ◽

Meta Analyses

Purpose: To examine the effect of a prenatal exercise intervention on gestational weight gain (GWG) and to update meta-analyses. Design: Randomized controlled trial and meta-analysis. Setting: Obstetrical practices in a Western Massachusetts hospital. Patients: We analyzed 241 ethnically diverse pregnant participants at high risk for gestational diabetes in the Behaviors Affecting Baby and You (B.A.B.Y.) study. A total of 118 participants were randomized to an exercise intervention group and 123 to a comparison health and wellness intervention group. Intervention: A 12-week individually tailored, motivationally matched program designed to increase the compliance with guidelines for exercise during pregnancy (30 min/day). Measures: The GWG and compliance with 2009 Institute of Medicine (IOM) guidelines for GWG abstracted from medical records. Analysis: Unadjusted logistic regression, intent-to-treat. Results were added to the existing meta-analyses using a random effects model. Results: Women randomized to the exercise group had a lower mean GWG than the comparison group (−0.97 kg, P value = .39) and were less likely to exceed IOM guidelines (odds ratio = 0.69, 95% confidence interval [CI] 0.34-1.40), but results were not statistically significant. Meta-analyses yielded a −0.63 kg (95% CI −1.17 to −0.08, P = .02) reduction in GWG and a 20% reduction in odds of exceeding IOM guidelines (95% CI 0.73 to 0.89) for the exercise intervention. Conclusion: Findings from this randomized trial among ethnically diverse women contribute to the results of meta-analyses supporting exercise as a means of attenuating GWG.

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