scholarly journals Structured, multifactorial randomised controlled intervention to investigate physical activity levels, body composition and diet in obese and overweight adolescents

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044895
Author(s):  
Prateek Srivastav ◽  
Vaishali K ◽  
Vinod H Bhat ◽  
Suzanne Broadbent
Keyword(s):  
Physical Activity ◽  
Body Composition ◽  
Controlled Trial ◽  
Overweight And Obesity ◽  
Dietary Advice ◽  
Activity Levels ◽  
Registration Number ◽  
Family Based ◽  
Group B ◽  
Randomised Controlled

IntroductionThere has been a steep increase in the prevalence of adolescent overweight and obesity globally and in India, demonstrating that present prevention strategies are insufficient. Available evidence suggests that multifactorial interventions may improve short-term physical activity (PA), nutrition and psychological behaviour of overweight and obese adolescents but long-term follow-ups and strategies are needed. This study will investigate the effects of a structured multifactorial (school-based and family-based) intervention on adolescent obesity, compared with a single or no intervention.Methods and analysisA pragmatic, clustered randomised controlled trial with 12 weeks of interventions and 3-month, 6-month and 12-month follow-ups will be conducted at multiple participating schools in Karnataka, India. The participants will be overweight and obese male and female adolescents aged 11–16 years and will be randomly assigned by school into three groups: group A (multifactorial intervention, exercise and dietary advice); group B (exercise only); and group C (controls, no interventions). Primary outcome measures are the level of PA and body composition. Secondary outcomes are dietary change, behaviour change, food behaviours, cardiovascular and muscular fitness, quality of life, parental behaviours (physical and mental) and family functioning. Positive intervention results may reduce obesity in adolescents and promote a healthier lifestyle for students and families. A larger, culturally diverse population can benefit from a similar methodology.Ethics and disseminationThe study has been approved by the Institutional Research and Ethics Committee (IEC 536-2018), Kasturba Hospital, Manipal, Udupi District, Karnataka, India. A written and verbal informed consent (supplemental material) will be provided to the participants prior to participation. On completion of the trial, the results can be communicated to adolescents and their parents on request, and will be published at national and international conferences and in peer-reviewed journals.Trial registration numberCTRI/2019/04/018834.

scholarly journals Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016966 ◽  
Author(s):  
Sarah Thomas ◽  
Louise Fazakarley ◽  
Peter W Thomas ◽  
Sarah Collyer ◽  
Sarah Brenton ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Well Being ◽  
Recruitment Rate ◽  
Controlled Study ◽  
Activity Levels ◽  
Nintendo Wii ◽  
Serious Adverse Events ◽  
Randomised Controlled

ObjectivesWhile the health and well-being benefits of physical activity are recognised, people with multiple sclerosis (MS) often face greater barriers than the general population. The Nintendo Wii potentially offers a fun, convenient way of overcoming some of these. The aim was to test the feasibility of conducting a definitive trial of the effectiveness and cost-effectiveness of Mii-vitaliSe; a home-based, physiotherapist-supported Nintendo Wii intervention.DesignA single-centre wait-list randomised controlled study.SettingMS service in secondary care.ParticipantsAmbulatory, relatively inactive people with clinically confirmed MS.InterventionThirty participants were randomised to receive Mii-vitaliSe either immediately (for 12 months) or after a 6-month wait (for 6 months). Mii-vitaliSe consisted of two supervised Nintendo Wii familiarisation sessions in the hospital followed by home use (Wii Sports, Sports Resort and Fit Plus software) with physiotherapist support and personalised resources.OutcomesIncluded self-reported physical activity levels, quality of life, mood, self-efficacy, fatigue and assessments of balance, gait, mobility and hand dexterity at baseline, 6 and 12 months. Interviews (n=25) explored participants’ experiences and, at study end, the two Mii-vitaliSe facilitators’ experiences of intervention delivery (main qualitative findings reported separately).ResultsMean (SD) age was 49.3 (8.7) years, 90% female, with 47% diagnosed with MS <6 years ago and 60% new to active gaming. The recruitment rate was 31% (95% CI 20% to 44%). Outcome data were available for 29 (97%) at 6 months and 28 (93%) at 12 months. No serious adverse events were reported during the study. Qualitative data indicated that Mii-vitaliSe was well-received. Mean Wii use across both groups over the initial 6-month intervention period was twice a week for 27 min/day. Mean cost of delivering Mii-vitaliSe was £684 per person.DiscussionMii-vitaliSe appears acceptable and a future trial feasible and warranted. These findings will inform its design.Trial registrationISRCTN49286846

scholarly journals App-assured essential physical activity for the prevention of cognitive decline: changing paradigms in public health – a study protocol for a randomised controlled trial

2021 ◽  
pp. e530
Author(s):  
Małgorzata Jamka ◽  
Aleksandra Makarewicz ◽  
Maria Wasiewicz-Gajdzis ◽  
Jan Brylak ◽  
Hanna Wielińska-Wiśniewska ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cognitive Decline ◽  
Cognitive Assessment ◽  
Controlled Trial ◽  
Normal Activity ◽  
Activity Levels ◽  
Brain Volumes ◽  
Before And After ◽  
One Year ◽  
Randomised Controlled

This study aims to assess the effect of an increase in daily physical activity to prevent cognitive decline, sustain brain volumes and maintain healthy biomarker levels in previously inactive (< 7,000 steps/day) mild cognitive impairment (MCI) subjects aged 50-65 years. In total, 198 subjects with MCI (assessed using the Montreal Cognitive Assessment test) will be recruited and randomised into two groups: active and passive. The active group will be instructed, encouraged and motivated to increase their physical activity to a moderate level (≥ 10,000 steps/day), while the passive group should maintain their normal activity levels. All subjects will undergo cognitive assessment, neuroimaging and biomarker tests before and after a one-year intervention. During the intervention, physical activity will be measured by the Fitbit Inspire HR wristband. The study was registered in the German Clinical Trials Register database (registration no. DRKS00020943, date of registration: 09.03.2020, protocol version: 1.0).

scholarly journals Whole family-based physical activity promotion intervention: the Families Reporting Every Step to Health pilot randomised controlled trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e030902 ◽  
Author(s):  
Justin M Guagliano ◽  
Helen Elizabeth Brown ◽  
Emma Coombes ◽  
Elizabeth S Haines ◽  
Claire Hughes ◽  
...  
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Family Members ◽  
Physical Activity Promotion ◽  
Activity Promotion ◽  
Ethical Approval ◽  
Family Based ◽  
Randomised Controlled

IntroductionFamily-based physical activity (PA) interventions present a promising avenue to promote children’s activity; however, high-quality experimental research is lacking. This paper describes the protocol for the FRESH (Families Reporting Every Step to Health) pilot trial, a child-led family-based PA intervention delivered online.Methods and analysisFRESH is a three-armed, parallel-group, randomised controlled pilot trial using a 1:1:1 allocation ratio with follow-up assessments at 8 and 52 weeks postbaseline. Families will be eligible if a minimum of one child in school Years 3–6 (aged 7–11 years) and at least one adult responsible for that child are willing to participate. Family members can take part in the intervention irrespective of their participation in the accompanying evaluation and vice versa.Following baseline assessment, families will be randomly allocated to one of three arms: (1) FRESH; (2) pedometer-only or (3) no-intervention control. All family members in the pedometer-only and FRESH arms receive pedometers and generic PA promotion information. FRESH families additionally receive access to the intervention website; allowing participants to select step challenges to ‘travel’ to target cities around the world, log steps and track progress as they virtually globetrot. Control families will receive no treatment. All family members will be eligible to participate in the evaluation with two follow-ups (8 and 52 weeks). Physical (eg, fitness and blood pressure), psychosocial (eg, social support) and behavioural (eg, objectively measured family PA) measures will be collected at each time point. At 8-week follow-up, a mixed methods process evaluation will be conducted (questionnaires and family focus groups) assessing acceptability of the intervention and evaluation. FRESH families’ website engagement will also be explored.Ethics and disseminationThis study received ethical approval from the Ethics Committee for the School of the Humanities and Social Sciences at the University of Cambridge. Findings will be disseminated via peer-reviewed publications, conferences and to participating families.Trial registration numberISRCTN12789422

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