scholarly journals Feasibility, user experiences, and preliminary effect of Conversation Cards for Adolescents© on collaborative goal-setting and behavior change: protocol for a pilot randomized controlled trial

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
M. Kebbe ◽  
A. Farmer ◽  
M. P. Dyson ◽  
S. D. Scott ◽  
T. L. F. McHugh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Real World ◽  
Controlled Trial ◽  
Full Scale ◽  
Practice Setting ◽  
User Experiences ◽  
Randomized Controlled ◽  
And Behavior ◽  
Pilot Randomized Controlled Trial

Abstract Background Adolescents and providers can benefit from practical tools targeting lifestyle modification for obesity prevention and management. We created Conversation Cards for Adolescents© (CCAs), a patient-centered communication and behavior change tool for adolescents and providers to use in clinical practice. The purpose of our study is to (i) assess the feasibility of CCAs in a real-world, practice setting to inform full-scale trial procedures, (ii) assess user experiences of CCAs, and (iii) determine the preliminary effect of CCAs on changing behavioral and affective-cognitive outcomes among adolescents. Methods Starting in early 2019, this prospective study is a nested mixed-methods, theory-driven, and pragmatic pilot randomized controlled trial with a goal to enroll 50 adolescents (13–17 years old) and 9 physicians practicing at the Northeast Community Health Centre in Edmonton, Alberta, Canada. Adolescents will collaboratively set one S.M.A.R.T. (specific, measurable, attainable, realistic, timely) goal with their physician to implement over a 3-week period; however, only those randomized to the experimental group will use CCAs to inform their goal. Outcome assessments at baseline and follow-up (3 weeks post-baseline) will include behavioral, affective-cognitive, and process-related outcomes. Discussion In examining the feasibility, user experiences, and preliminary effect of CCAs, our study will add contributions to the obesity literature on lifestyle modifications among adolescents in a real-world, practice setting as well as inform the scalability of our approach for a full-scale effectiveness randomized controlled trial on behavior change. Trial registration ClinicalTrials.gov Identifier: NCT03821896.

scholarly journals Be sweet to toddlers during needles: pilot randomized controlled trial of sucrose compared to placebo

2015 ◽  
Vol 5 (1) ◽  
Author(s):  
Denise Harrison ◽  
Jessica Reszel ◽  
Nick Barrowman ◽  
Brenda Martelli ◽  
Diane Sharp ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Needle Insertion ◽  
Full Scale ◽  
Size Estimation ◽  
Randomized Controlled ◽  
Pain Outcomes ◽  
Pilot Rct ◽  
Collection Data ◽  
Pilot Randomized Controlled Trial

Sweet solutions reduce procedural pain in infants but there is uncertainty about effectiveness beyond infancy. A blinded pilot randomized controlled trial (RCT) was conducted to inform a full-scale RCT. Hospitalized children aged 12- 36 months were randomized to 24% sucrose or water prior to and during venipuncture. Primary outcomes were crying time and FLACC (Face, Legs, Activity, Cry, Consolability) scores. Secondary outcomes parental report of child’s pain, parental perception of effectiveness and nurse’s score of child’s compliance with study solution. Twenty-one children were studied. There were no differences in pain outcomes between groups. Median FLACC scores at time of needle insertion were high (8/10), and mean crying time during procedure was 61%. Most parents (n=17) would use the same treatment next time and most (n=17) toddlers were compliant with receiving the solutions. The pilot RCT informed the conduct of a future full scale RCT in terms of feasibility, acceptability, data collection, data analysis and sample size estimation.

scholarly journals Specialized Nutritious Food Combined With Cash Transfers and Social and Behavior Change Communication to Prevent Stunting Among Children Aged 6 to 23 Months in Pakistan: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Gul Nawaz Khan ◽  
Sumra Kureishy ◽  
Shabina Ariff ◽  
Muhammad Atif Habib ◽  
Asra Abeer Usmani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Rural Areas ◽  
Controlled Trial ◽  
Cash Transfers ◽  
Monthly Basis ◽  
Randomized Controlled ◽  
Change Communication ◽  
Cluster Randomized ◽  
And Behavior

BACKGROUND In Pakistan, the prevalence of stunting in children younger than 5 years has remained above global critical levels over the past two decades, with the stunting rate being 40.2% in 2018. Children living in rural areas and in the poorest households suffer the most from stunting across the country—43.2% in rural areas and 51.4% in the lowest wealth quintile. As a continuing public health concern, it is essential that stunting prevention is a national priority in order to ensure human capital development, especially among the poorest households. OBJECTIVE The primary objective of this study is to determine the effect of a medium quantity of a lipid-based nutrient supplement (LNS) combined with unconditional cash transfers and social and behavior change communication (SBCC) on reduction of stunting in children aged 6 to 23 months. METHODS A 5-arm cluster randomized controlled trial will be conducted in the district of Rahim Yar Khan in Punjab, Pakistan. The intervention packages will be (1) cash only, (2) cash with LNS, (3) cash with SBCC, and (4) cash with SBCC and LNS. The control arm will receive routine standard of care. We will enroll children at 6 months of age and follow up on a monthly basis up to 24 months of age. A total of 2000 children, 400 in each arm, will be enrolled to detect a 20% reduction in the prevalence of stunting among children aged 24 months. Length, weight, food intake, compliance to interventions, morbidities, and other relevant data will be collected at enrollment and on a monthly basis over the period of 18 months. The process evaluation will assess acceptability of the interventions and potential barriers to implementation through focus group discussions and in-depth interviews with the target population and relevant stakeholders. Furthermore, a cost analysis will be conducted to assess the cost-effectiveness of each intervention package. RESULTS The study protocol was approved by the Ethics Review Committee of Aga Khan University in Pakistan on January 4, 2017. Data collection began in May 2017 and was completed in July 2019. Data analyses are yet to be completed. This study will explore the effectiveness of intervention packages comprised of cash transfers from Benazir Income Support Programme with or without additional LNS and SBCC in preventing childhood stunting. We expect the results to be published in peer-reviewed journals by autumn of 2020. CONCLUSIONS The findings of this trial will provide robust evidence as to which intervention packages can have significant effects on linear growth of children and design effective intervention packages to prevent stunting in children aged 6 to 23 months. CLINICALTRIAL ClinicalTrials.gov NCT03299218; https://clinicaltrials.gov/ct2/show/NCT03299218 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19001

scholarly journals MOTIVATIONAL INTERVIEWING TO ENGAGE OLDER INPATIENTS IN FALL PREVENTION: PILOT RANDOMIZED CONTROLLED TRIAL

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S292-S292
Author(s):  
Hiroko Kiyoshi-Teo ◽  
Kathlynn Northrup-Snyder ◽  
Elizabeth Eckstrom ◽  
Debbie Cohen ◽  
Nathan Dieckmann ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Motivational Interviewing ◽  
Fall Prevention ◽  
Fear Of Falling ◽  
Controlled Trial ◽  
Hospital Setting ◽  
Randomized Controlled ◽  
Older Inpatients ◽  
Pilot Randomized Controlled Trial

Abstract Motivational Interviewing (MI) is an evidence-based approach for fostering behavior change and holds potential to engage patients in behavior change related to fall prevention. A two-arm, unblinded, pilot randomized controlled trial was conducted in a hospital setting to determine the feasibility (recruitment and retention), establish suitable procedures for the intervention (duration and quality of MI), and to test study measurements (fear of falling, importance and confidence related to fall prevention, patient activation, fall prevention behaviors, and fall rates). Participants were high fall risk older inpatients (age ≥ 65). The intervention arm received MI at one time during hospitalization in addition to routine hospital fall prevention intervention. The control arm received the routine hospital care for fall prevention only. Measures were collected at baseline, 2-days, 1-week, 1-month, and 3-month. A total of 120 inpatients were contacted by the study team and 67 were randomized: intervention arm (n=36) and control arm (n=31). Approximately 66% of participants completed the study at the 3-month data collection and MI intervention took an average of 21 minutes and was of adequate quality. The intervention group reported less fear of falling after the MI intervention and maintained fall prevention behaviors over time (p<.05). The study identified that MI for fall prevention at a hospital setting was feasible to deliver and provided insights into suitable study procedures and beginning evidence for a positive impact of MI.

scholarly journals Specialized Nutritious Food Combined With Cash Transfers and Social and Behavior Change Communication to Prevent Stunting Among Children Aged 6 to 23 Months in Pakistan: Protocol for a Cluster Randomized Controlled Trial

10.2196/19001 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e19001
Author(s):  
Gul Nawaz Khan ◽  
Sumra Kureishy ◽  
Shabina Ariff ◽  
Muhammad Atif Habib ◽  
Asra Abeer Usmani ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Rural Areas ◽  
Controlled Trial ◽  
Cash Transfers ◽  
Monthly Basis ◽  
Randomized Controlled ◽  
Change Communication ◽  
Cluster Randomized ◽  
And Behavior

Background In Pakistan, the prevalence of stunting in children younger than 5 years has remained above global critical levels over the past two decades, with the stunting rate being 40.2% in 2018. Children living in rural areas and in the poorest households suffer the most from stunting across the country—43.2% in rural areas and 51.4% in the lowest wealth quintile. As a continuing public health concern, it is essential that stunting prevention is a national priority in order to ensure human capital development, especially among the poorest households. Objective The primary objective of this study is to determine the effect of a medium quantity of a lipid-based nutrient supplement (LNS) combined with unconditional cash transfers and social and behavior change communication (SBCC) on reduction of stunting in children aged 6 to 23 months. Methods A 5-arm cluster randomized controlled trial will be conducted in the district of Rahim Yar Khan in Punjab, Pakistan. The intervention packages will be (1) cash only, (2) cash with LNS, (3) cash with SBCC, and (4) cash with SBCC and LNS. The control arm will receive routine standard of care. We will enroll children at 6 months of age and follow up on a monthly basis up to 24 months of age. A total of 2000 children, 400 in each arm, will be enrolled to detect a 20% reduction in the prevalence of stunting among children aged 24 months. Length, weight, food intake, compliance to interventions, morbidities, and other relevant data will be collected at enrollment and on a monthly basis over the period of 18 months. The process evaluation will assess acceptability of the interventions and potential barriers to implementation through focus group discussions and in-depth interviews with the target population and relevant stakeholders. Furthermore, a cost analysis will be conducted to assess the cost-effectiveness of each intervention package. Results The study protocol was approved by the Ethics Review Committee of Aga Khan University in Pakistan on January 4, 2017. Data collection began in May 2017 and was completed in July 2019. Data analyses are yet to be completed. This study will explore the effectiveness of intervention packages comprised of cash transfers from Benazir Income Support Programme with or without additional LNS and SBCC in preventing childhood stunting. We expect the results to be published in peer-reviewed journals by autumn of 2020. Conclusions The findings of this trial will provide robust evidence as to which intervention packages can have significant effects on linear growth of children and design effective intervention packages to prevent stunting in children aged 6 to 23 months. Trial Registration ClinicalTrials.gov NCT03299218; https://clinicaltrials.gov/ct2/show/NCT03299218 International Registered Report Identifier (IRRID) DERR1-10.2196/19001

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