scholarly journals Impact of a farmers’ market nutrition coupon programme on diet quality and psychosocial well-being among low-income adults: protocol for a randomised controlled trial and a longitudinal qualitative investigation

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e035143 ◽  
Author(s):  
Michelle L Aktary ◽  
Stephanie Caron-Roy ◽  
Tolulope Sajobi ◽  
Heather O'Hara ◽  
Peter Leblanc ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Research Ethics ◽  
Diet Quality ◽  
Low Income ◽  
Controlled Trial ◽  
Well Being ◽  
Farmers Markets ◽  
Post Intervention ◽  
Farmers Market ◽  
Randomised Controlled

IntroductionLow-income populations have poorer diet quality and lower psychosocial well-being than their higher-income counterparts. These inequities increase the burden of chronic disease in low-income populations. Farmers’ market subsidies may improve diet quality and psychosocial well-being among low-income populations. In Canada, the British Columbia (BC) Farmers’ Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers’ markets. This study will assess the impact of the BC FMNCP on the diet quality and psychosocial well-being of low-income adults and explore mechanisms of programme impacts.Methods and analysisIn a parallel group randomised controlled trial, low-income adults will be randomised to an FMNCP intervention (n=132) or a no-intervention control group (n=132). The FMNCP group will receive 16 coupon sheets valued at CAD$21/sheet over 10–15 weeks to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts and herbs at farmers’ markets and will be invited to participate in nutrition skill-building activities. Overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, food insecurity and malnutrition risk (secondary outcomes) will be assessed at baseline, immediately post-intervention and 16 weeks post-intervention. Dietary intake will be assessed using the Automated Self-Administered 24-hour Dietary Recall. Diet quality will be calculated using the Healthy Eating Index-2015. Repeated measures mixed-effect regression will assess differences in outcomes between groups from baseline to 16 weeks post-intervention. Furthermore, 25–30 participants will partake in semi-structured interviews during and 5 weeks after programme completion to explore participants’ experiences with and perceived outcomes from the programme.Ethics and disseminationEthical approval was obtained from the University of Calgary Conjoint Health Research Ethics Board, Rutgers University Ethics and Compliance, and University of Waterloo Office of Research Ethics. Findings will be disseminated through policy briefs, conference presentations and peer-reviewed publications.Trial registration numberNCT03952338.

scholarly journals Online single-session interventions for Kenyan adolescents: study protocol for a comparative effectiveness randomised controlled trial

2021 ◽  
Vol 34 (3) ◽  
pp. e100446
Author(s):  
Akash R Wasil ◽  
Tom Lee Osborn ◽  
John R Weisz ◽  
Robert J DeRubeis
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Comparative Effectiveness ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Well Being ◽  
Single Session ◽  
Post Intervention ◽  
Digital Interventions ◽  
Randomised Controlled

BackgroundMental health problems are the leading cause of disability among adolescents worldwide, yet access to treatment is limited. Brief digital interventions have been shown to improve youth mental health, but little is known about which digital interventions are most effective.AimsTo evaluate the effectiveness of two digital single-session interventions (Shamiri-Digital and Digital-CBT (cognitive-behavioural therapy)) among Kenyan adolescents.MethodsWe will perform a school-based comparative effectiveness randomised controlled trial. Approximately 926 Kenyan adolescents will be randomly assigned to one of three conditions: Shamiri-Digital (focused on gratitude, growth mindsets and values), Digital-CBT (focused on behavioural activation, cognitive restructuring and problem solving) or a study-skills control condition (focused on note-taking and essay writing skills). The primary outcomes include depressive symptoms (measured by the Patient Health Questionnaire-8), anxiety symptoms (Generalized Anxiety Disorder Screener-7) and subjective well-being (Short Warwick-Edinburgh Mental Well-being Scale). The secondary outcomes include acceptability, appropriateness, primary control and secondary control. Acceptability and appropriateness will be measured immediately post-intervention; other outcomes will be measured 2 weeks, 4 weeks and 12 weeks post-intervention.ResultsWe hypothesise that adolescents assigned to Shamiri-Digital and adolescents assigned to Digital-CBT will experience greater improvements (assessed via hierarchical linear models) than those assigned to the control group. We will also compare Shamiri-Digital with Digital-CBT, although we do not have a preplanned hypothesis.ConclusionsOur findings will help us evaluate two digital single-session interventions with different theoretical foundations. If effective, such interventions could be disseminated to reduce the public health burden of common mental health problems.Trial registration numberPACTR202011691886690.

scholarly journals Moving from intention to behaviour: a randomised controlled trial protocol for an app-based physical activity intervention (i2be)

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e053711
Author(s):  
Lili L Kókai ◽  
Diarmaid T Ó Ceallaigh ◽  
Anne I Wijtzes ◽  
Jeanine E Roeters van Lennep ◽  
Martin S Hagger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Well Being ◽  
Behaviour Change Techniques ◽  
Automatic Processes ◽  
Post Intervention ◽  
Randomised Controlled

IntroductionEfficacy tests of physical activity interventions indicate that many have limited or short-term efficacy, principally because they do not sufficiently build on theory-based processes that determine behaviour. The current study aims to address this limitation.Methods and analysisThe efficacy of the 8-week intervention will be tested using a three-condition randomised controlled trial delivered through an app, in women with a prior hypertensive pregnancy disorder. The intervention is based on the integrated behaviour change model, which outlines the motivational, volitional and automatic processes that lead to physical activity. The mechanisms by which the behaviour change techniques lead to physical activity will be tested.Following stratification on baseline factors, participants will be randomly allocated in-app to one of three conditions (1:1:1). The information condition will receive information, replicating usual care. Additionally to what the information condition receives, the motivation condition will receive content targeting motivational processes. Additionally to what the motivation condition receives, the action condition will receive content targeting volitional and automatic processes.The primary outcome is weekly minutes of moderate-to-vigorous physical activity, as measured by an activity tracker (Fitbit Inspire 2). Secondary outcomes include weekly average of Fitbit-measured daily resting heart rate, and self-reported body mass index, waist-hip ratio, cardiorespiratory fitness and subjective well-being. Tertiary outcomes include self-reported variables representing motivational, volitional, and automatic processes. Outcome measures will be assessed at baseline, immediately post-intervention, and at 3 and 12 months post-intervention. Physical activity will also be investigated at intervention midpoint. Efficacy will be determined by available case analysis. A process evaluation will be performed based on programme fidelity and acceptability measures.Ethics and disseminationThe Medical Ethics Committee of the Erasmus MC has approved this study (MEC-2020-0981). Results will be published in peer reviewed scientific journals and presented at scientific conferences.Trial registration numberNetherlands trial register, NL9329.

scholarly journals Effects of a peer co-facilitated educational programme for parents of children with ADHD: a feasibility randomised controlled trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e039852
Author(s):  
Ingunn Mundal ◽  
Rolf W Gråwe ◽  
Hege Hafstad ◽  
Carlos De las Cuevas ◽  
Mariela Loreto Lara-Cabrera
Keyword(s):  
Randomised Controlled Trial ◽  
Sample Size ◽  
Controlled Trial ◽  
Well Being ◽  
Educational Programme ◽  
Parental Engagement ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled ◽  
Parent Activation

IntroductionSignificant numbers of children with attention deficit hyperactivity disorder (ADHD) display problems that cause multiple disabilities, deficits and handicaps that interfere with social relationships, development and school achievement. They may have multiple problems, which strain family dynamics and influence the child’s treatment. Parent activation, described as parents’ knowledge, skills and confidence in dealing with their child’s health and healthcare, has been shown to be an important factor in improving health outcomes. Research suggests that parents need edification to learn skills crucial to the treatment and management of their children’s healthcare. Promoting positive parenting techniques may reduce negative parenting factors in families. This study aims to assess the acceptability, feasibility and estimated sample size of a randomised controlled trial (RCT) comparing an ADHD peer co-led educational programme added to treatment as usual (TAU).Methods and analysisUsing a randomised waitlist controlled trial, parents of children aged 6–12 years newly diagnosed with ADHD, and referred to a child mental health outpatient clinic in Mid-Norway, will receive TAU concomitant with a peer co-facilitated parental engagement educational programme (n=25). Parents in the control group will receive TAU, and the educational programme treatment within a waitlist period of 3–6 months (n=25). Parent activation, satisfaction, well-being, quality of life and treatment adherence, will be assessed at baseline (T0), 2 weeks (T1) pre–post intervention (T2, T3) and at 3 months follow-up (T4). Shared decision making, parents preferred role in health-related decisions and involvement, parent-reported symptoms of ADHD and child’s overall level of functioning will be assessed at T0 and T4. Such data will be used to calculate the required sample size for a full-scale RCT.Ethics and disseminationApproval was obtained from the Regional Committee for Medicine and Health Research Ethics in Mid-Norway (ref: 2018/1196). The findings of this study are expected to provide valuable knowledge about how to optimise family education and management of ADHD and will be disseminated through presentations at conferences and publication in peer-reviewed journals.Trial registration numberNCT04010851.

scholarly journals Study design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: a cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e042850
Author(s):  
Karin Leder ◽  
John J Openshaw ◽  
Pascale Allotey ◽  
Ansariadi Ansariadi ◽  
S Fiona Barker ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Human Health ◽  
Controlled Trial ◽  
Informal Settlements ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Cluster Randomised ◽  
Abundance And Diversity ◽  
Randomised Controlled ◽  
Health And Well Being

IntroductionIncreasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysisRISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.EthicsStudy protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration numberACTRN12618000633280; Pre-results.

scholarly journals “My coupons are like gold”: experiences and perceived outcomes of low-income adults participating in the British Columbia Farmers’ Market Nutrition Coupon Program

2021 ◽  
pp. 1-30
Author(s):  
Stéphanie Caron-Roy ◽  
Sayeeda Amber Sayed ◽  
Katrina Milaney ◽  
Bonnie Lashewicz ◽  
Sharlette Dunn ◽  
...  
Keyword(s):  
British Columbia ◽  
Rural Communities ◽  
Low Income ◽  
Well Being ◽  
Qualitative Description ◽  
Farmers Markets ◽  
Social Connections ◽  
Structured Interviews ◽  
Program Outcomes ◽  
Farmers Market

ABSTRACT Objective: The British Columbia Farmers’ Market Nutrition Coupon Program (FMNCP) provides low-income households with coupons valued at $21/week for 16 weeks to purchase healthy foods in farmers’ markets. Our objective was to explore FMNCP participants’ experiences of accessing nutritious foods, and perceived program outcomes. Design: This study used qualitative description methodology. Semi-structured interviews were conducted with FMNCP participants during the 2019 farmers’ market season. Directed content analysis was used to analyse the data whereby the five domains of Freedman et al’s framework of nutritious food access provided the basis for an initial coding scheme. Data that did not fit within the framework’s domains were coded inductively. Setting: One urban and two rural communities in British Columbia, Canada. Participants: 28 adults who were participating in the FMNCP. Results: Three themes emerged: Autonomy and Dignity; Social Connections and Community Building; and Environmental and Programmatic Constraints. Firstly, the program promoted a sense of autonomy and dignity through financial support, increased access to high-quality produce, food-related education and skill development, and mitigating stigma and shame. Secondly, shopping in farmers’ markets increased social connections and fostered a sense of community. Finally, participants experienced limited food variety in rural farmers’ markets, lack of transportation, and challenges with redeeming coupons. Conclusions: Participation in the FMNCP facilitated access to nutritious foods and enhanced participants’ diet quality, well-being and health. Strategies such as increasing the amount and duration of subsidies, and expanding programs may help improve participants’ experiences and outcomes of farmers’ market food subsidy programs.

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

scholarly journals Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Education ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Post Intervention ◽  
Cognitive Behavioural ◽  
Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

A randomised controlled trial to test a non-metallic deodorant used during a course of radiotherapy

2000 ◽  
Vol 1 (4) ◽  
pp. 205-212 ◽  
Author(s):  
A. Gee ◽  
D. Moffitt ◽  
M. Churn ◽  
R.D. Errington
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Psychological Benefits ◽  
Weekly Basis ◽  
Skin Reactions ◽  
Treated Area ◽  
The Past ◽  
Randomised Controlled ◽  
Larger Sample

Background: Radiotherapy skin reactions have been well documented in the past. Until recently, washing of the treated area and the use of perfumed products that contain metals has not been advocated during treatment. The aims of this study were to assess the skin reactions of patients using a non-metallic deodorant and to see whether there were any psychological benefits from being able to use the deodorant.Method: 41 women attending for radiotherapy to either the breast or breast and axilla were recruited into the trial. They were randomised into one of two groups. Complete data was obtained for 36 patients. 20 patients used the deodorant and 16 did not. Any skin reactions noted were recorded on a weekly basis. Patients were also asked to complete a questionnaire relating to feelings and activities and to comment on the deodorant if they had used it.Results: Skin reactions did seem to be slightly worse in the patients using deodorant, and it was only in this group of patients that axillary reactions were noted. However, neither of these results were statistically significant. The use of the deodorant did not have any impact on the psychological well being of the patients, but patients using it had found it pleasant to use and the majority said that they would use it again.Conclusion: Further study is indicated to look at skin reactions using the deodorant with a larger sample of patients.

scholarly journals Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034137 ◽  
Author(s):  
Dimitris Papamargaritis ◽  
Werd Al-Najim ◽  
Jonathan Lim ◽  
James Crane ◽  
Mike Lean ◽  
...  
Keyword(s):  
Weight Loss ◽  
Randomised Controlled Trial ◽  
Research Ethics ◽  
Real World ◽  
Regulatory Authority ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Stopping Rules ◽  
Open Label ◽  
Randomised Controlled

IntroductionIn the UK and Ireland, severe and complex obesity is managed in specialist weight management services (SWMS), which provide multicomponent lifestyle interventions to support weight loss, and use of medication if available. Liraglutide 3 mg (LIRA 3 mg) is an effective weight-loss medication, but weight loss in individual patients is variable, and its efficacy has not been assessed in SWMS. This study aims to investigate whether a targeted prescribing pathway for LIRA 3 mg with multiple prespecified stopping rules could help people with severe obesity and established complications achieve ≥15% weight loss in order to determine whether this could be considered a clinically effective and cost-effective strategy for managing severe and complex obesity in SWMS.Methods and analysisIn this 2-year, multicentre, open-label, real-world randomised controlled trial, 384 adults with severe and complex obesity (defined as body mass index ≥35 kg/m2plus either prediabetes, type 2 diabetes, hypertension or sleep apnoea) will be randomised via a 2:1 ratio to receive either standard SWMS care (n=128) or standard SWMS care plus a targeted prescribing pathway for LIRA 3 mg with prespecified stopping rules at 16, 32 and 52 weeks (n=256).The primary outcome is to compare the proportion of participants achieving a weight loss of ≥15% at 52 weeks with a targeted prescribing pathway versus standard care. Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting.Ethics and disseminationThe Health Research Authority and the Medicines and Healthcare products Regulatory Authority in UK, the Health Products Regulatory Authority in Ireland, the North West Deanery Research Ethics Committee (UK) and the St Vincent’s University Hospital European Research Ethics Committee (Ireland) have approved the study. The findings of the study will be published in peer-reviewed journals.Trial registration numberClinicalTrials.gov—Identifier:NCT03036800.European Clinical Trials Database—Identifier: EudraCT Number 2017-002998-20.

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