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Abstract Background A Phase I study showed that it is feasible to implement a home-based self-management program aimed at increasing physical activity in individuals after stroke with mild walking disability in Brazil. The next step is to test this program against a control group in order to provide a power analysis for a fully-powered Phase III clinical trial. Methods A Phase II pilot randomised clinical trial with concealed allocation, blinded measurement, and intention-to-treat analyses will be carried out. The inclusion criteria will be individuals diagnosed with stroke, in the acute or subacute phase, with mild walking disability, sedentary, and no significant language impairment. The participants will be randomly allocated to the experimental or control group. The experimental group will receive six sessions of a home-based self-management program based on behaviour change techniques through the Social-Cognitive Theory and Control Theory over 11 weeks. The control group will receive one session of education about stroke (regarding the importance of practising physical activity after a stroke) and usual care. A total of 24 participants will be recruited. The primary outcome will be physical activity, measured through steps taken per day by an activity monitor (Actigraph wGT3X-BT, Pensacola, FL, USA). The mean of daily steps will be analysed to compare groups after intervention. Secondary outcomes will be cardiovascular risk (body mass index, waist circumference, and blood pressure), depressive symptoms (Geriatric Depression Scale), walking ability (6-Minute Walk Test and 10-Meter Walk Test), exercise self-efficacy (Self-Efficacy for Exercise scale), social participation (Stroke Impact Scale) and quality of life (EuroQual-5D). Two-way analyses of variance will be implemented for all parametric outcomes, and the Kruskal–Wallis test for non-parametric outcomes will be used to determine the statistical significance of the between-group differences and reported as mean differences between groups (95% CI). All analyses will be conducted intention-to-treat. All outcomes will be measured at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). This pilot clinical trial was registered online at Clinical Trials under number NCT05461976 on 4th April 2022. Discussion If beneficial, this Phase II pilot randomised trial will provide data to plan a fully powered future Phase III clinical trial aimed at verifying the efficacy of this program to promote physical activity after stroke. Trial registration Clinical Trials NCT05461976 on 4th April 2022.

Background: A Phase I study showed that it is feasible to implement a home-based self-management program aimed at increasing physical activity in individuals after stroke with mild walking disability in Brazil. The next step is to test this program against a control group in order to provide a power analysis for a fully-powered Phase III clinical trial. Methods: A Phase II pilot randomised clinical trial with concealed allocation, blinded measurement, and intention-to-treat analyses will be carried out. The inclusion criteria will be individuals diagnosed with stroke, in the acute or subacute phase, with mild walking disability, sedentary, and no significant language impairment. The participants will be randomly allocated to the experimental or control group. The experimental group will receive six sessions of a home-based self-management program based on behaviour change techniques through the Social-Cognitive Theory and Control Theory over 11 weeks. The control group will receive one session of education about stroke (regarding the importance of practising physical activity after a stroke) and usual care. A total of 24 participants will be recruited. The primary outcome will be physical activity, measured through steps taken per day by an activity monitor (Actigraph wGT3X-BT, Pensacola, FL, USA). The mean of daily steps will be analysed to compare groups after intervention. Secondary outcomes will be cardiovascular risk (body mass index, waist circumference, and blood pressure), depressive symptoms (Geriatric Depression Scale), walking ability (6-Minute Walk Test and 10-Meter Walk Test), exercise self-efficacy (Self-Efficacy for Exercise scale), social participation (Stroke Impact Scale) and quality of life (EuroQual-5D). Two-way analyses of variance will be implemented for all parametric outcomes, and the Kruskal–Wallis test for non-parametric outcomes will be used to determine the statistical significance of the between-group differences and reported as mean differences between groups (95% CI). All analyses will be conducted intention-to-treat. All outcomes will be measured at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). This pilot clinical trial was registered online at Clinical Trials under number NCT05461976 on 4th April 2022. Discussion: If beneficial, this Phase II pilot randomised trial will provide data to plan a fully powered future Phase III clinical trial aimed at verifying the efficacy of this program to promote physical activity after stroke. Trial registration: Clinical Trials NCT05461976 on 4th April 2022. [ABSTRACT FROM AUTHOR]

Previous evidence suggests physical activity interventions effectively produce short-term improvements in physical function for older adults. The present study examined whether improvements in physical function after a DVD-delivered exercise intervention were maintained 18 months postintervention. Older adults (n = 153) randomized to a 6-month DVD-delivered exercise intervention or an attentional control condition were contacted 18 months postintervention. Participants completed the Short Physical Performance Battery (SPPB) and measures of flexibility, strength, and functional limitations were taken. Analyses of variance were conducted to determine if improvements in physical function as a result of the intervention were maintained at follow-up. Improvements in the SPPB, F (1,125) = 3.70, p = .06, η2 = .03, and upper body strength, F (1,121) = 3.04, p = .08, η2 = .03 were maintained for the intervention condition. Home-based DVD exercise training interventions may hold promise for long-term maintenance of physical function in older adults. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to assess the feasibility and acceptability of a home‐based intervention—Amagugu Asakhula—to promote nurturing interactions and healthy behaviours with the caregivers of preschool children. Amagugu Asakhula means "treasures that are still growing" and focuses on children's cognitive development, physical activity, screen time, diet and sleep while also promoting the caregiver–child relationship. Methods: This study took place in a low‐income setting in Cape Town, South Africa. The 6‐week intervention was implemented by community health workers (CHWs) with 20 caregivers of preschool children. CHWs provided written feedback on intervention sessions, and two focus groups were conducted, one with the CHWs involved (n = 4) and another with caregivers (n = 6), to obtain their feedback on the intervention and its implementation. Data were collated according to themes relating to implementation. In this pilot study, training and recruitment proved feasible and were facilitated by partnership with a community‐based organization. Results: The intervention was generally implemented as intended, in terms of dose and delivery. Family support and active engagement of caregivers' preschool children in intervention activities were reported by CHWs and caregivers, and CHWs also reported mostly positive interactions with caregivers. CHWs and caregivers perceived the intervention to have benefits relating to the following: caregivers' awareness and knowledge of health behaviours, awareness of their role, changes in behaviours, and connection between the caregiver and child. The only change to the intervention suggested was the inclusion of some group sessions to promote support amongst intervention participants and sustain engagement in the intervention. Conclusions: The findings of this pilot study indicate that Amagugu Asakhula was both feasible and acceptable with caregivers of preschool children in a low‐income urban setting. Further research is needed to assess the extent to which this intervention has an objective and measurable effect on intended outcomes. [ABSTRACT FROM AUTHOR]

Background and Objectives: Nutrition and physical activity interventions is beneficial in reversing obesity. However far too little attention has been paid to the effect of these interventions on breast tissues. Thus, the aim of this study was to explore the effect of a home-based dietary and physical activity intervention (the Her Shape Program) on metabolic parameters, blood biomarkers and adiposity at the breast.Methods and Study Design: A randomized controlled study was conducted on obese women with high breast adiposity (<0.1 Sm-1), aged 40-60 years in Klang Valley, Malaysia. Subjects were assigned to intervention (n=16) and control group (n=15). Intervention group received a home based health education package with close monitoring weekly, personal diet consultation and physical training in group. Assessment was ascertained at three time points; baseline, weeks 8 and 16. Outcome measures were the energy intake, physical activity, body composition, blood tests, blood biomarkers and electrical impedance tomography (EIT) quantitative values. Analyses were done using 2-way repeated measures ANOVA.Results and Conclusions: All subjects completed the program without any drop-out. The HSI group had 100% compliance towards the intervention program; their energy intake was reduced for approximately 35% and their activity score was increased for approximately 11%. A significant interaction effect was found in body weight, body mass index (BMI), total cholesterol/HDL, vitamin C intake and matrix metallopeptidase 9 (MMP-9) (p<0.05). Interestingly, their EIT extremum values were also significantly increased indicating a reduction of breast adiposity. The intervention program was successful in improving body composition, physical activities, MMP9 and breast adipose tissue composition. [ABSTRACT FROM AUTHOR]

ObjectiveAmerican Indian children of pre-school age have disproportionally high obesity rates and consequent risk for related diseases. Healthy Children, Strong Families was a family-based randomized trial assessing the efficacy of an obesity prevention toolkit delivered by a mentor v. mailed delivery that was designed and administered using community-based participatory research approaches.DesignDuring Year 1, twelve healthy behaviour toolkit lessons were delivered by either a community-based home mentor or monthly mailings. Primary outcomes were child BMI percentile, child BMI Z-score and adult BMI. Secondary outcomes included fruit/vegetable consumption, sugar consumption, television watching, physical activity, adult health-related self-efficacy and perceived health status. During a maintenance year, home-mentored families had access to monthly support groups and all families received monthly newsletters.SettingFamily homes in four tribal communities, Wisconsin, USA.SubjectsAdult and child (2–5-year-olds) dyads (n 150).ResultsNo significant effect of the mentored v. mailed intervention delivery was found; however, significant improvements were noted in both groups exposed to the toolkit. Obese child participants showed a reduction in BMI percentile at Year 1 that continued through Year 2 (P<0·05); no change in adult BMI was observed. Child fruit/vegetable consumption increased (P=0·006) and mean television watching decreased for children (P=0·05) and adults (P=0·002). Reported adult self-efficacy for health-related behaviour changes (P=0·006) and quality of life increased (P=0·02).ConclusionsAlthough no effect of delivery method was demonstrated, toolkit exposure positively affected adult and child health. The intervention was well received by community partners; a more comprehensive intervention is currently underway based on these findings. [ABSTRACT FROM AUTHOR]