Reducing Sitting Time in Obese Older Adults: The I-STAND Randomized Controlled Trial

2020 ◽  
Vol 28 (6) ◽  
pp. 864-874 ◽  
Author(s):  
Dori E. Rosenberg ◽  
Melissa L. Anderson ◽  
Anne Renz ◽  
Theresa E. Matson ◽  
Amy K. Lee ◽  
...  
Keyword(s):  
Older Adults ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Sitting Time ◽  
Group Differences ◽  
Control Group ◽  
Linear Regression Models ◽  
Health Promoting ◽  
Secondary Outcomes ◽  
To Receive

Background: The authors tested the efficacy of the “I-STAND” intervention for reducing sitting time, a novel and potentially health-promoting approach, in older adults with obesity. Methods: The authors recruited 60 people (mean age = 68 ± 4.9 years, 68% female, 86% White; mean body mass index = 35.4). The participants were randomized to receive the I-STAND sitting reduction intervention (n = 29) or healthy living control group (n = 31) for 12 weeks. At baseline and at 12 weeks, the participants wore activPAL devices to assess sitting time (primary outcome). Secondary outcomes included fasting glucose, blood pressure, and weight. Linear regression models assessed between-group differences in the outcomes. Results: The I-STAND participants significantly reduced their sitting time compared with the controls (–58 min per day; 95% confidence interval [–100.3, –15.6]; p = .007). There were no statistically significant changes in the secondary outcomes. Conclusion: I-STAND was efficacious in reducing sitting time, but not in changing health outcomes in older adults with obesity.

scholarly journals A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lara Bücker ◽  
Josefine Gehlenborg ◽  
Steffen Moritz ◽  
Stefan Westermann
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Group Differences ◽  
Control Group ◽  
Gambling Problems ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

scholarly journals Feasibility and Subjective Effectiveness Assessment Using a Mobile Health Application for a Health Management Applied Traditional Medicine Perspective: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Younghwa Baek ◽  
Kyungsik Jeong ◽  
Siwoo Lee ◽  
Hoseok Kim ◽  
Bok-Nam Seo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mobile Health ◽  
Primary Outcome ◽  
Health Management ◽  
Controlled Trial ◽  
Control Group ◽  
Health Promoting Behaviors ◽  
Randomized Controlled ◽  
Health Promoting ◽  
Secondary Outcomes

BACKGROUND Mobile health (mHealth) is a major source of health management systems such as health promotion behavior, chronic disease, and mental illness. Moreover, mHealth, a new model of digital healthcare in need of change due to the COVID-19 pandemic, will increase and demand for use worldwide. Accordingly, interest in health care in everyday life and the importance of mobile health are growing. OBJECTIVE We developed a MibyeongBogam (MBBG) application that evaluates the user’s subhealth status by use of a smartphone and provides a health management method based on that user’s subhealth status for use in everyday life. The primary objective of this study was to compare health status awareness after the use of the MBBG application between the intervention and control groups, and to evaluate the application’s practicality. METHODS This study was a prospective, open-label, parallel group, randomized controlled trial as an intervention for MBBG. The study was conducted at two hospitals in Korea with 150 healthy people in their 30s and 40s, at a 1:1 allocation ratio. Participants visited the hospital three times: pre-intervention, intermediate visit six weeks after intervention, and final visit 12 weeks after intervention. Key endpoints were measured at the first visit before intervention and at 12 weeks after intervention. The primary outcome was the awareness of subhealth status and secondary outcomes were health status, health-promoting behaviors, and motivation for healthy behaviors. RESULTS The primary outcome, subhealth awareness, tended to slightly increase in both groups after the uncompensated intervention, but there was no significant difference between groups (MBBG group = 23.69±0.25, control group = 23.1±0.25, p=0.088). In the case of secondary outcomes, only some variables of subhealth status showed significant differences between the two groups after intervention, and the intervention group showed an improvement in the total score of subhealth (p = 0.025), sleep disturbance (p = 0.024), depression (p = 0.003), anger (p = 0.01), and anxiety symptoms (p = 0.009) compared to the control group. CONCLUSIONS In this study, the MBBG application showed positive potential for improving the health, especially the mental health, of individuals without particular health problems. However, the effects of the application on health-promoting behaviors were not clearly evaluated. Therefore, further studies to assess improvements in health after the use of personalized health management programs provided by the MBBG application would need to be performed. It is thought that the MBBG application would be useful for the general public, who are not diagnosed with a disease but cannot enjoy an optimal daily life due to discomfort, to seek strategies that can improve their health. CLINICALTRIAL Clinical Research Information Service, KCT0003488. (https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=14379)

scholarly journals 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

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.

scholarly journals Does tension applied in kinesio taping affect pain or function in older women with knee osteoarthritis? A randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041121
Author(s):  
Yago Tavares Pinheiro ◽  
Germanna Medeiros Barbosa ◽  
Hilmaynne Renaly Fonseca Fialho ◽  
César Augusto Medeiros Silva ◽  
Jaciara de Oliveira Anunciação ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Knee Osteoarthritis ◽  
Older Women ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Group Differences ◽  
Control Group ◽  
Kinesio Taping ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveTo analyse the short-term effects of kinesio taping (KT) with tension (KTT) or without tension (KTNT) in older women with knee osteoarthritis (KOA), and compare them to controls who did not receive KT.DesignRandomised controlled trial.SettingUniversity physiotherapy school clinic.ParticipantsForty-five older women (fifteen participants per group) with 66.8 (±5.6) years and clinical diagnosis of KOA were assessed pre, post and 3 days after intervention.InterventionsParticipants were randomly allocated to KTT, who received two simultaneous applications of KT with tension on the knee and rectus femoris; KTNT, who received the same application as the KTT group, but without tension and a control group that attended a class on KOA.Primary and secondary outcome measuresPrimary outcome was pain intensity and secondary outcomes were knee-related health status, functional capacity, muscle strength and global rating of change.ResultsNo between-group differences were observed in pain after the first intervention (KTT vs KTNT: mean difference (MD), −1.8 points; 95% CI −4.2 to 0.5; KTT vs control: MD, −1.2 points; 95% CI −3.6 to 1.2; KTNT vs control: MD, 0.66 points; 95% CI −1.7 to 3.0) or 3 days later (KTT vs KTNT: MD, −1.3 points; 95% CI −3.7 to 1.0; KTT vs control: MD, 0.13 points; 95% CI −2.2 to 2.5; KTNT vs control: MD, 1.4 points; 95% CI −0.9 to 3.8). The lack of between-group differences was also found for secondary outcomes.ConclusionThe short-term use of KT with or without tension in older woman with KOA had no beneficial effects on pain and function. These findings call into question the clinical use of KT as a non-pharmacological therapy for this population.Trial registration numberNCT03624075.

scholarly journals Tepid sponging plus dipyrone versus dipyrone alone for reducing body temperature in febrile children

2008 ◽  
Vol 126 (2) ◽  
pp. 107-111 ◽  
Author(s):  
João Guilherme Bezerra Alves ◽  
Natália Dornelas Câmara Marques de Almeida ◽  
Camila Dornelas Câmara Marques de Almeida
Keyword(s):  
Clinical Trial ◽  
Body Temperature ◽  
Randomized Clinical Trial ◽  
Primary Outcome ◽  
Control Group ◽  
Emergency Ward ◽  
Axillary Temperature ◽  
Secondary Outcomes ◽  
To Receive

CONTEXT AND OBJECTIVE: The role of tepid sponging to promote fever control in children is controversial. We did not find any studies reporting on the effectiveness of tepid sponging in addition to dipyrone. The aim of this study was to compare the effects of tepid sponging plus dipyrone with dipyrone alone for reducing fever. DESIGN AND SETTING: A randomized clinical trial was undertaken at Instituto Materno-Infantil Professor Fernando Figueira, Recife, Pernambuco. METHODS: Children from six months to five years old with axillary temperature greater than 38 ºC in the emergency ward between January and July 2006 were eligible. One hundred and twenty children were randomly assigned to receive oral dipyrone (20 mg/kg) or oral dipyrone and tepid sponging for 15 minutes. The primary outcome was mean temperature reduction after 15, 30, 60, 90 and 120 minutes. Secondary outcomes were crying and irritability. RESULTS: 106 children finished the study. After the first 15 minutes, the fall in axillary temperature was significantly greater in the sponged group than in the control group (p < 0.001). From 30 to 120 minutes, better fever control was observed in the control group. Crying and irritability were observed respectively in 52% and 36% of the sponged children and in none and only two of the controls. CONCLUSIONS: Tepid sponging plus dipyrone cooled faster during the first 15 minutes, but dipyrone alone presented better fever control over the two-hour period. Tepid sponging caused mild discomfort, crying and irritability for most of the children.

scholarly journals Does sensory relearning improve tactile function after carpal tunnel decompression? A pragmatic, assessor-blinded, randomized clinical trial

2016 ◽  
Vol 41 (9) ◽  
pp. 948-956 ◽  
Author(s):  
C. Jerosch-Herold ◽  
J. Houghton ◽  
L. Miller ◽  
L. Shepstone
Keyword(s):  
Carpal Tunnel ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Hand Function ◽  
Group Differences ◽  
Level Of Evidence ◽  
Significant Treatment ◽  
Significant Group ◽  
Group A ◽  
Secondary Outcomes

Despite surgery for carpal tunnel syndrome being effective in 80%–90% of cases, chronic numbness and hand disability can occur. The aim of this study was to investigate whether sensory relearning improves tactile discrimination and hand function after decompression. In a multi-centre, pragmatic, randomized, controlled trial, 104 patients were randomized to a sensory relearning ( n = 52) or control ( n = 52) group. A total of 93 patients completed a 12-week follow-up. Primary outcome was the shape-texture identification test at 6 weeks. Secondary outcomes were touch threshold, touch localization, dexterity and self-reported hand function. No significant group differences were seen for the primary outcome (Shape-Texture Identification) at 6 weeks or 12 weeks. Similarly, no significant group differences were observed on secondary outcomes, with the exception of self-reported hand function. A secondary complier-averaged-causal-effects analysis showed no statistically significant treatment effect on the primary outcome. Sensory relearning for tactile sensory and functional deficits after carpal tunnel decompression is not effective. Level of Evidence: II

Pilot Randomized Controlled Trial: Elastic-Resistance-Training and Lifestyle-Activity Intervention for Sedentary Older Adults

2013 ◽  
Vol 21 (1) ◽  
pp. 20-32 ◽  
Author(s):  
David R. Lubans ◽  
Chris M. Mundey ◽  
Nicole J. Lubans ◽  
Chris C. Lonsdale
Keyword(s):  
Older Adults ◽  
Muscle Strength ◽  
Controlled Trial ◽  
Control Group ◽  
Lower Body ◽  
Significant Group ◽  
Lifestyle Activity ◽  
Body Muscle ◽  
Activity Program ◽  
Secondary Outcomes

The aim of this study was to determine the efficacy and feasibility of a resistancetraining (RT) and lifestyle-activity program for sedentary older adults. Eligible participants (N= 44) were randomized to an 8-wk intervention or a control group. The primary outcome was lower body muscle strength, and participants completed a range of secondary outcomes. There was a significant group-by-time interaction for lower body muscle strength (difference = 3.9 repetitions [reps], 95% CI = 2.0–5.8 reps;p< .001;d= 1.0). Changes in secondary outcomes were generally small and not statistically significant. Attendance and program satisfaction were both high. A combined elastic-tubing RT and lifestyle-activity program delivered in the community setting is an efficacious and feasible approach to improve health in sedentary older adults.

scholarly journals Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040183
Author(s):  
Dominika Kwasnicka ◽  
Aleksandra Luszczynska ◽  
Martin S Hagger ◽  
Eleanor Quested ◽  
Sherry L Pagoto ◽  
...  
Keyword(s):  
Time Series ◽  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Weight Loss Maintenance ◽  
Control Group ◽  
Promote Weight Loss ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionDigital behavioural weight loss interventions have the potential to improve public health; however, these interventions are often not adequately tailored to the needs of the participants. This is the protocol for a trial that aims to determine the effectiveness and cost-effectiveness of the Choosing Health programme as a means to promote weight loss and weight loss maintenance among overweight/obese adults.Methods and analysisThe proposed study is a two-group randomised controlled trial with a nested interrupted time series (ITS) within-person design. Participants (n=285) will be randomly assigned to either the Choosing Health digital intervention or a control group. For intervention participants, ecological momentary assessment will be used to identify behavioural determinants for each individual in order to tailor evidence-based behaviour change techniques and intervention content.Control group participants will receive non-tailored weight loss advice via e-book and generic emails. The primary outcome is the mean difference in weight loss between groups at 6 months controlled for baseline. Secondary outcomes include blood pressure and percentage of body fat; self-reported measures of physical activity, sitting time, quality of life, cost and theory-derived correlates of weight loss. Secondary outcomes will be measured at baseline, 3, 6 and 12 months. The primary outcome for ITS will be daily weight loss plan adherence. Data will be analysed using regression and time series analyses.Ethics and disseminationEthics approval was granted by Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland, approval number 03/P/12/2019. The project results will be disseminated through structured strategy implemented in collaboration with the Ministry of Health.Trial registration detailsThis trial was registered with www.clinicaltrials.gov; registration number NCT04291482.

scholarly journals Short-term effect of a chronic pain self-management intervention delivered by an easily accessible primary healthcare service: a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e023017 ◽  
Author(s):  
Torunn Hatlen Nøst ◽  
Aslak Steinsbekk ◽  
Ola Bratås ◽  
Kjersti Grønning
Keyword(s):  
Chronic Pain ◽  
Healthcare Service ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Patient Activation ◽  
Self Management ◽  
Control Group ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectivesTo investigate the effects on persons with chronic pain after 3 months of a group-based chronic pain self-management course compared with a drop-in, low-impact outdoor physical group activity on patient activation and a range of secondary outcomes.DesignAn open, pragmatic, parallel group randomised controlled trial. Analyses were performed using a two-level linear mixed model.SettingAn easily accessible healthcare service provided by Norwegian public primary healthcare.ParticipantsA total of 121 participants with self-reported chronic pain for 3 months or more were randomised with 60 participants placed in the intervention group and 61 placed in the control group (mean age 53 years, 88% women, 63% pain for 10 years or more).InterventionsThe intervention group was offered a group-based chronic pain self-management course with 2.5-hour weekly sessions for a period of 6 weeks. The sessions consisted of education, movement exercises and emphasised group discussions. The control group was offered a low-impact outdoor group physical activity in 1-hour weekly sessions that consisted of walking and simple strength exercises for a period of 6 weeks.Main outcomesThe primary outcome was patient activation assessed using the Patient Activation Measure. Secondary outcomes measured included assessments of pain, anxiety and depression, pain self-efficacy, sense of coherence, health-related quality of life, well-being and the 30 s chair to stand test.ResultsThere was no effect after 3 months of the group-based chronic pain self-management course compared with the control group for the primary outcome, patient activation (estimated mean difference: −0.5, 95% CI –4.8 to 3.7, p=0.802).ConclusionsThere was no support for the self-management course having a better effect after 3 months than a low-impact outdoor physical activity offered the control group.Trial registration numberNCT02531282; Results.

scholarly journals The efficacy of motivational counselling and SMS reminders on daily sitting time in patients with rheumatoid arthritis: a randomised controlled trial

2017 ◽  
Vol 76 (9) ◽  
pp. 1603-1606 ◽  
Author(s):  
Tanja Thomsen ◽  
Mette Aadahl ◽  
Nina Beyer ◽  
Merete Lund Hetland ◽  
Katrine Løppenthin ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Sitting Time ◽  
Control Group ◽  
Behavioural Intervention ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
General Self Efficacy ◽  
Motivational Counselling

ObjectivesThe aim of this report is to investigate the efficacy of an individually tailored, theory-based behavioural intervention for reducing daily sitting time, pain and fatigue, as well as improving health-related quality of life, general self-efficacy, physical function and cardiometabolic biomarkers in patients with rheumatoid arthritis (RA).MethodsIn this randomised controlled trial 150 patients with RA were randomised to an intervention or a no-intervention control group. The intervention group received three individual motivational counselling sessions and short message service or text messages aimed at reduction of sedentary behaviour during the 16-week intervention period. Primary outcome was change in daily sitting time measured objectively by ActivPAL. Secondary outcomes included change in pain, fatigue, physical function, general self-efficacy, quality of life, blood pressure, blood lipids, haemoglobin A1c, body weight, body mass index, waist circumference and waist–hip ratio.Results75 patients were allocated to each group. Mean reduction in daily sitting time was −1.61 hours/day in the intervention versus 0.59 hours/day increase in the control group between-group difference −2.20 (95% CI −2.72 to −1.69; p<0.0001) hours/day in favour of the intervention group. Most of the secondary outcomes were also in favour of the intervention.ConclusionAn individually tailored, behavioural intervention reduced daily sitting time in patients with RA and improved patient-reported outcomes and cholesterol levels.Trial registration numberNCT01969604; Results.

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