scholarly journals Feasibility and Preliminary Efficacy of the MADE4Life Program: A Pilot Randomized Controlled Trial

2015 ◽  
Vol 12 (10) ◽  
pp. 1378-1393 ◽  
Author(s):  
Alyce T. Barnes ◽  
Ronald C. Plotnikoff ◽  
Clare E. Collins ◽  
Philip J. Morgan
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Primary Outcome Measure ◽  
Sedentary Behaviors ◽  
Mothers And Daughters ◽  
Significant Group ◽  
Randomized Controlled ◽  
Secondary Outcomes

Background:The aim was to assess the feasibility and preliminary efficacy of a community-based physical activity (PA) intervention targeting mothers and daughters.Methods:A randomized controlled trial of 48 primary school-aged girls and their 40 mothers were randomized to (i) Mothers And Daughters Exercising for Life (MADE4Life) (n = 21 mothers, n = 25 daughters) or (ii) wait-list control (n = 19 mothers, n = 23 daughters). The 8-week program involved 8 sessions; 25-minute separate mothers and daughters education sessions and 60-minutes PA together. Assessments were at baseline, postintervention and 3-month postintervention. Primary outcome measure was daughters’ moderateto-vigorous physical activity (MVPA) (accelerometer). Secondary outcomes included accelerometer-assessed light/moderate/vigorous PA, BMI, waist circumference, body composition, blood pressure, resting heart rate, sedentary behaviors and mothers’ self-reported PA, parenting measures, and cognitions. Intention-to-treat analysis used linear mixed models.Results:Recruitment and retention goals were exceeded. Attendance rates, program acceptability and satisfaction were high. There was no significant group-by-time effect for daughters’ %MVPA (–0.08; 95%CI –1.49, 1.33, d = –0.03) or other secondary outcomes for girls (postintervention range d = 0.01 to –0.46). Significant intervention effects were found for mothers’ %VPA (P = .04, d = 0.25) and role modeling (P = .02, d = 0.66).Conclusion:MADE4Life was both feasible and acceptable. Although very small effect sizes were found for the daughters, significant changes were seen for mothers (d = 0.25 to 0.66). Future fully powered trials targeting PA in mothers and daughters is warranted.

scholarly journals The “Healthy Habits, Healthy Girls” randomized controlled trial for girls: study design, protocol, and baseline results

2015 ◽  
Vol 31 (7) ◽  
pp. 1381-1394 ◽  
Author(s):  
Ana Carolina Barco Leme ◽  
Sonia Tucunduva Philippi
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Waist Circumference ◽  
Study Design ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Activity Level ◽  
Randomized Controlled ◽  
Healthy Habits ◽  
Design Protocol

The purpose of this article is to describe the study design, protocol, and baseline results of the “Healthy Habits, Healthy Girls” program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

scholarly journals The Effects of Aerobic Versus Cognitively Demanding Exercise Interventions on Executive Functioning in School-Aged Children: A Cluster-Randomized Controlled Trial

2020 ◽  
pp. 1-13
Author(s):  
Anna Meijer ◽  
Marsh Königs ◽  
Irene M.J. van der Fels ◽  
Chris Visscher ◽  
Roel J. Bosker ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Executive Functioning ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Verbal Working Memory ◽  
Control Group ◽  
Exercise Interventions ◽  
Randomized Controlled

The authors performed a clustered randomized controlled trial to investigate the effects of an aerobic and a cognitively demanding exercise intervention on executive functions in primary-school-age children compared with the regular physical education program (N = 856). They hypothesized that both exercise interventions would facilitate executive functioning, with stronger effects for the cognitively demanding exercise group. The interventions were provided four times per week for 14 weeks. Linear mixed models were conducted on posttest neurocognitive function measures with baseline level as covariate. No differences were found between the exercise interventions and the control group for any of the measures. Independently of group, dose of moderate to vigorous physical activity was positively related to verbal working memory and attention abilities. This study showed that physical exercise interventions did not enhance executive functioning in children. Exposure to moderate to vigorous physical activity is a crucial aspect of the relationship between physical activity and executive functioning.

Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

2020 ◽  
Vol 47 (4) ◽  
pp. 451-462
Author(s):  
Júlia Caetano Martins ◽  
Sylvie Nadeau ◽  
Larissa Tavares Aguiar ◽  
Aline Alvim Scianni ◽  
Luci Fuscaldi Teixeira-Salmela ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

scholarly journals Effectiveness of a 3-Month Mobile Phone–Based Behavior Change Program on Active Transportation and Physical Activity in Adults: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Anna Ek ◽  
Christina Alexandrou ◽  
Emmie Söderström ◽  
Patrick Bergman ◽  
Christine Delisle Nyström ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Intervention Group ◽  
Active Transportation ◽  
Randomized Controlled ◽  
Behavior Change Program

BACKGROUND Active transportation (AT; ie, walking and cycling as a mode for transportation) has been associated with decreased morbidity and mortality; however, low-cost and scalable intervention programs are lacking. OBJECTIVE The goal of the research was to determine the effectiveness of a 3-month behavior change program delivered via a mobile phone app to promote AT (TravelVu Plus) on time spent in moderate-to-vigorous physical activity (MVPA). METHODS For this 2-arm parallel randomized controlled trial, we recruited a population-based sample of 254 adults from Stockholm County who were aged 20 to 65 years and had access to a smartphone. On completion of 1-week baseline measures, the 254 participants were randomized to either the control or intervention group (1:1 ratio). Both groups had access to the standard TravelVu app (Trivector AB) for monitoring their AT for 6 months. The intervention group also received a 3-month behavior change program to promote AT (TravelVu Plus app). Assessors of outcomes were blinded to group allocation. Outcomes were objectively measured MVPA at 3 (primary) and 6 months. Secondary outcomes were AT, attitudes toward AT, and health-related quality of life at 3 and 6 months. RESULTS No effect on MVPA was observed after 3 months (<i>P</i>=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; <i>P</i>=.04]). A Bayesian analyses showed that there was a 98% probability that the intervention had any effect at 6 months, and a 63% probability that this effect was &gt;5 minute MVPA per day. CONCLUSIONS No effect on MVPA immediately after the intervention period (at 3 months) was observed; however, there was a delayed effect on MVPA (6 minutes per day) at 6 months, which corresponds to approximately 30% of the weekly MVPA recommendation. Our findings suggest that a behavior change program promoting AT delivered via an app may have a relevant effect on PA. CLINICALTRIAL ClinicalTrials.gov NCT03086837; https://clinicaltrials.gov/ct2/show/NCT03086837 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-018-5658-4

scholarly journals Effects of a 12-Week Multifaceted Wearable-Based Program for People With Knee Osteoarthritis: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Linda C Li ◽  
Lynne M Feehan ◽  
Hui Xie ◽  
Na Lu ◽  
Christopher D Shaw ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Mean Difference ◽  
Knee Oa ◽  
Counseling Intervention ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Secondary Outcomes

BACKGROUND Current guidelines emphasize an active lifestyle in the management of knee osteoarthritis (OA), but up to 90% of patients with OA are inactive. In a previous study, we demonstrated that an 8-week physiotherapist (PT)-led counseling intervention, with the use of a Fitbit, improved step count and quality of life in patients with knee OA, compared with a control. OBJECTIVE This study aimed to examine the effect of a 12-week, multifaceted wearable-based program on physical activity and patient outcomes in patients with knee OA. METHODS This was a randomized controlled trial with a delay-control design. The immediate group (IG) received group education, a Fitbit, access to FitViz (a Fitbit-compatible app), and 4 biweekly phone calls from a PT over 8 weeks. Participants then continued using Fitbit and FitViz independently up to week 12. The delay group (DG) received a monthly electronic newsletter in weeks 1 to 12 and started the same intervention in week 14. Participants were assessed in weeks 13, 26, and 39. The primary outcome was time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini. Secondary outcomes included daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index. RESULTS We enrolled 51 participants (IG: n=26 and DG: n=25). Compared with the IG, the DG accumulated significantly more MVPA time at baseline. The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5). A significant effect was also found in the adjusted mean difference in perceived sitting habit at work (0.7; 95% CI 0.2 to 1.2) and during leisure activities (0.7; 95% CI 0.2 to 1.2). No significant effect was found in the remaining secondary outcomes. CONCLUSIONS A 12-week multifaceted program with the use of a wearable device, an app, and PT counseling improved physical activity in people with knee OA. CLINICALTRIAL ClinicalTrials.gov NCT02585323; https://clinicaltrials.gov/ct2/show/NCT02585323

scholarly journals Implementation of a School Physical Activity Policy Improves Student Physical Activity Levels: Outcomes of a Cluster-Randomized Controlled Trial

2020 ◽  
Vol 17 (10) ◽  
pp. 1009-1018
Author(s):  
Nicole K. Nathan ◽  
Rachel L. Sutherland ◽  
Kirsty Hope ◽  
Nicole J. McCarthy ◽  
Matthew Pettett ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
School Day ◽  
Cluster Randomized ◽  
The Impact

Aim: To assess the impact of a multistrategy intervention designed to improve teachers’ implementation of a school physical activity (PA) policy on student PA levels. Methods: A cluster-randomized controlled trial was conducted in 12 elementary schools. Policy implementation required schools to deliver 150 minutes of organized PA for students each week via physical education, sport, or class-based activities such as energizers. Schools received implementation support designed using the theoretical domains framework to help them implement the current policy. Results: A total of 1,502 children in kindergarten to grade 6 participated. At follow-up compared with control, students attending intervention schools had, measured via accelerometer, significantly greater increases in school day counts per minute (97.5; 95% confidence interval [CI], 64.5 to 130.4; P < .001) and moderate to vigorous physical activity (MVPA) (3.0; 95% CI, 2.2–3.8, P < .001) and a greater decrease in sedentary time (−2.1; 95% CI, −3.9 to −0.4, P = .02) per school day. Teachers in intervention schools delivered significantly more minutes (36.6 min) of PA to their students at follow-up (95% CI, 2.7–70.5, P = .04). Conclusions: Supporting teachers to implement a PA policy improves student PA. Additional strategies may be needed to support teachers to implement activities that result in larger gains in student MVPA.

REducing SEDENTary Behavior Among Mild to Moderate Cognitively Impaired Assisted Living Residents: A Pilot Randomized Controlled Trial (RESEDENT Study)

2020 ◽  
pp. 1-9
Author(s):  
K. Dillon ◽  
Harry Prapavessis
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Randomized Controlled Trial ◽  
Cognitive Function ◽  
Assisted Living ◽  
Controlled Trial ◽  
Sitting Time ◽  
Sedentary Behaviors ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Older adults in assisted living spend most of their day in sedentary behaviors, which may be detrimental to cognitive function. The primary purpose of this pilot study was to assess the feasibility of using a prompting device to reduce sitting time with light walking among older adults with mild to moderate cognitive impairment residing in an assisted living setting. A secondary purpose was to examine the effectiveness of the intervention on the residents’ cognitive function, physical function, and quality of life. The participants (n = 25, mean age = 86.7 [5.3] years) were assigned in clusters into a two-arm 10-week single-site pilot randomized controlled trial. The intervention group was prompted with a watch to interrupt sedentary behaviors and partake in 10 min of light physical activity (i.e., walking) three times a day after a meal. The assessments included hip-worn accelerometers (Actical) and diaries, the Alzheimer’s disease assessment scale—cognitive, Timed Up and Go, and the short-form 36 health survey. Adherence was high, as there were no dropouts, and over 70% of the participants completed over 80% of the prescribed physical activity bouts. Significant effects favoring the intervention were shown for all outcomes.

scholarly journals Effect of Yoga versus Light Exercise to Improve Well-Being and Promote Healthy Aging among Older Adults in Central India: A Study Protocol for a Randomized Controlled Trial

Geriatrics ◽  
2019 ◽  
Vol 4 (4) ◽  
pp. 64 ◽  
Author(s):  
Choudhary ◽  
Pathak ◽  
Manickam ◽  
Purohit ◽  
Rajasekhar ◽  
...  
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Central India ◽  
Well Being ◽  
Medical College ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Multiple Health

Background: Aging is a natural process associated with many functional and structural changes. These changes may include impaired self-regulation, changes in tissues and organs. Aging also affects mood, physical status and social activity. There are adverse changes in cognitive behavior, perceived sensation and thinking processes. Regular physical activity can alleviate many health problems; yet, many older adults are inactive. Yoga is one of the scientific and popular lifestyle practice considered as the integration of mind, body and soul. Results of previous studies reported positive effects of yoga on multiple health outcomes in elderly. However, there is scarcity of scientific information where yoga’s effect is examined on over well-being and on multiple health outcomes simultaneously in elderly. This protocol describes methods for a 12-week yoga-based intervention exploring the effects of yoga on well-being in physically inactive elderly living in community. Methods and analysis: This two group parallel single blind randomized controlled trial that will be conducted at a designated facility of R.D. Gardi Medical College, Ujjain, Madhya Pradesh, Central India. A 12-week 60-min yoga intervention three times weekly is designed. Comparison group participants will undergo a 60-min program comprising light exercise focusing on conventional stretching to improve mobility. After screening, 144 participants aged 60–80 years will be recruited. The primary outcome is subjective well-being. Secondary outcomes include mobility, fall risk, cognition, anxiety and depression, mood and stress, sleep quality, pain, physical activity/sedentary behavior and cardio-metabolic risk factors. Assessments will be conducted at baseline (0 week), after the intervention (12+1 week) and at follow-up (36+1 week). Intention-to-treat analyses with mixed linear modeling will be applied. Discussion: Through this trial, we aim to determine whether elderly people in the intervention group practicing yoga show more favorable primary (well-being) and secondary outcomes than those in the light exercise focusing on conventional stretching group. We assume that yoga may be practiced to maintain health, reduce particular symptoms commonly associated with skeletal pain, assist in pain relief and enhance well-being. We anticipate that practicing yoga will improve well-being and mental health and may lead to significant improvement in depression, pain and sleep quality.Ethics and dissemination: This study is approved by the Institutional Ethics Committee of R.D. Gardi Medical College, Ujjain, IEC Ref No. 09/2018. All participants would be provided with written and verbal information about the purpose of the project and would be free to withdraw from the study at any time. Refusal to participate in the study would not have any negative consequences. Confidentiality of the information of each participant would be ensured. Knowledge obtained would be disseminated to stakeholders through workshops, meetings and relevant scientific conferences.Trial Registration: The trial is prospectively registered with the Indian Council of Medical Research Trial Registry CTRI/2018/07/015051.

Sign in / Sign up

Export Citation Format

Share Document