scholarly journals Process Evaluation of an eHealth Intervention (Food4toddlers) to Improve Toddlers' Diet: Randomized Controlled Trial

10.2196/18171 ◽  
2020 ◽  
Vol 7 (3) ◽  
pp. e18171
Author(s):  
Margrethe Røed ◽  
Frøydis Nordgård Vik ◽  
Elisabet Rudjord Hillesund ◽  
Wendy Van Lippevelde ◽  
Anine Christine Medin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Intervention Group ◽  
University Education ◽  
Family Composition ◽  
Management Platform ◽  
Randomized Controlled ◽  
Ehealth Intervention ◽  
Total P

Background Parents seek trustworthy information online to promote healthy eating for their toddlers. Such information must be perceived as relevant and easy to implement and use. Objective The objectives of this study were to conduct a process evaluation of the electronic health (eHealth) intervention (Food4toddlers) targeting food environment, parental feeding practices, and toddlers’ diet and to examine possible differences in these areas according to education and family composition. Methods A 2-armed randomized controlled trial, including 298 parent–toddler dyads from Norway, was conducted in 2017. In total, 148 parents in the intervention group received access to an intervention website for 6 months. Data on website usage were retrieved from the learning management platform used (NEO). Participants’ satisfaction with the intervention was asked for in a postintervention questionnaire. Chi-square and t tests were used to examine differences in usage and satisfaction between education and family composition groups. Results Most participants were mothers (144/148, 97.2%), lived in two-adult households (148/148, 100%), and were born in Norway (132/148, 89.1%). Mean parental age was 31.5 years (SD 4.2). More than 87.8% (129/147) had a university education degree and 56.5% (83/147) had over 4 years of university education. Most (128/148, 86.5%) intervention participants entered the website at least once (mean days of access 7.4 [SD 7.1]). Most parents reported the website as appropriate to the child’s age (71/83, 86%) and self-explanatory (79/83, 95%) and appreciated the interface (52/83, 63%) and layout (46/83, 55%). In total, 61% (51/83) stated that they learned something new from the intervention. Parents with over 4 years of university education and in 1-child households used the intervention website more than those with 4 years or less of university education (8.4 vs 5.9 days in total, P=.04) and households with more than 1 child (8.3 vs 5.8 days in total, P=.04), respectively. Conclusions The Food4toddlers intervention website was found to be relevant by most participants in the intervention group, although usage of the website differed according to educational level and family composition. For eHealth interventions to be effective, intervention materials such as websites must be used by the target group. Our results highlight the need to include users from different groups when developing interventions. Trial Registration ISRCTN Registry ISRCTN92980420; http://www.isrctn.com/ISRCTN92980420

scholarly journals Process Evaluation of an eHealth Intervention (Food4toddlers) to Improve Toddlers' Diet: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Margrethe Røed ◽  
Frøydis Nordgård Vik ◽  
Elisabet Rudjord Hillesund ◽  
Wendy Van Lippevelde ◽  
Anine Christine Medin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Intervention Group ◽  
University Education ◽  
Family Composition ◽  
Chi Square ◽  
Management Platform ◽  
Randomized Controlled ◽  
Ehealth Intervention

BACKGROUND Parents seek trustworthy information online to promote healthy eating for their toddlers. Such information must be perceived as relevant and easy to implement and use. OBJECTIVE The objectives of this study were to conduct a process evaluation of the electronic health (eHealth) intervention (Food4toddlers) targeting food environment, parental feeding practices, and toddlers’ diet and to examine possible differences in these areas according to education and family composition. METHODS A 2-armed randomized controlled trial, including 298 parent–toddler dyads from Norway, was conducted in 2017. In total, 148 parents in the intervention group received access to an intervention website for 6 months. Data on website usage were retrieved from the learning management platform used (NEO). Participants’ satisfaction with the intervention was asked for in a postintervention questionnaire. Chi-square and <i>t</i> tests were used to examine differences in usage and satisfaction between education and family composition groups. RESULTS Most participants were mothers (144/148, 97.2%), lived in two-adult households (148/148, 100%), and were born in Norway (132/148, 89.1%). Mean parental age was 31.5 years (SD 4.2). More than 87.8% (129/147) had a university education degree and 56.5% (83/147) had over 4 years of university education. Most (128/148, 86.5%) intervention participants entered the website at least once (mean days of access 7.4 [SD 7.1]). Most parents reported the website as appropriate to the child’s age (71/83, 86%) and self-explanatory (79/83, 95%) and appreciated the interface (52/83, 63%) and layout (46/83, 55%). In total, 61% (51/83) stated that they learned something new from the intervention. Parents with over 4 years of university education and in 1-child households used the intervention website more than those with 4 years or less of university education (8.4 vs 5.9 days in total, <i>P</i>=.04) and households with more than 1 child (8.3 vs 5.8 days in total, <i>P</i>=.04), respectively. CONCLUSIONS The Food4toddlers intervention website was found to be relevant by most participants in the intervention group, although usage of the website differed according to educational level and family composition. For eHealth interventions to be effective, intervention materials such as websites must be used by the target group. Our results highlight the need to include users from different groups when developing interventions. CLINICALTRIAL ISRCTN Registry ISRCTN92980420; http://www.isrctn.com/ISRCTN92980420

scholarly journals Effect of a Parent-Focused eHealth Intervention on Children’s Fruit, Vegetable, and Discretionary Food Intake (Food4toddlers): Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Margrethe Røed ◽  
Anine C Medin ◽  
Frøydis N Vik ◽  
Elisabet R Hillesund ◽  
Wendy Van Lippevelde ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Fruits And Vegetables ◽  
Vegetable Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Differences ◽  
Randomized Controlled ◽  
Ehealth Intervention ◽  
Child Age

BACKGROUND In western countries, children’s diets are often low in fruits and vegetables and high in discretionary foods. Diet in early life tends to track through childhood and youth and even into adulthood. Interventions should, therefore, be delivered in periods when habitual traits are established, as in toddlerhood when children adapt to their family’s diet. OBJECTIVE In this study, we assessed the effect of the Food4toddlers eHealth intervention, which aimed to enhance toddlers’ diets by shaping their food and eating environment. METHODS The Food4toddlers randomized controlled trial was conducted in Norway in 2017-2018. Parent-child dyads were recruited through social media. In total, 298 parents completed an online questionnaire at baseline (mean child age 10.9 months, SD 1.2). Postintervention questionnaires were completed immediately after the intervention (ie, follow-up 1; mean child age 17.8 months, SD 1.3) and 6 months after the intervention (ie, follow-up 2; mean child age 24.2 months, SD 1.9). The intervention was guided by social cognitive theory, which targets the linked relationship between the person, the behavior, and the environment. The intervention group (148/298, 49.7%) got access to the Food4toddlers website for 6 months from baseline. The website included information on diet and on how to create a healthy food and eating environment as well as activities, recipes, and collaboration opportunities. To assess intervention effects on child diet from baseline to follow-up 1 and from baseline to follow-up 2, we used generalized estimating equations and a time × group interaction term. Between-group differences in changes over time for frequency and variety of fruits and vegetables and frequency of discretionary foods were assessed. RESULTS At follow-up 1, a significant time × group interaction was observed for the frequency of vegetable intake (<i>P</i>=.02). The difference between groups in the change from baseline to follow-up 1 was 0.46 vegetable items per day (95% CI 0.06-0.86) in favor of the intervention group. No other significant between-group differences in dietary changes from baseline to follow-up 1 or follow-up 2 were observed. However, there is a clear time trend showing that the intake of discretionary foods increases by time from less than 1 item per week at baseline to more than 4 items per week at 2 years of age (<i>P</i>&lt;.001), regardless of group. CONCLUSIONS A positive intervention effect was observed for the frequency of vegetable intake at follow-up 1 but not at follow-up 2. No other between-group effects on diet were observed. eHealth interventions of longer duration, including reminders after the main content of the intervention has been delivered, may be needed to obtain long-terms effects, along with tailoring in a digital or a personal form. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 92980420; https://doi.org/10.1186/ISRCTN92980420

scholarly journals Effect of a Parent-Focused eHealth Intervention on Children’s Fruit, Vegetable, and Discretionary Food Intake (Food4toddlers): Randomized Controlled Trial

10.2196/18311 ◽  
2021 ◽  
Vol 23 (2) ◽  
pp. e18311
Author(s):  
Margrethe Røed ◽  
Anine C Medin ◽  
Frøydis N Vik ◽  
Elisabet R Hillesund ◽  
Wendy Van Lippevelde ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Fruits And Vegetables ◽  
Vegetable Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Differences ◽  
Randomized Controlled ◽  
Ehealth Intervention ◽  
Child Age

Background In Western countries, children’s diets are often low in fruits and vegetables and high in discretionary foods. Diet in early life tends to track through childhood and youth and even into adulthood. Interventions should, therefore, be delivered in periods when habitual traits are established, as in toddlerhood when children adapt to their family’s diet. Objective In this study, we assessed the effect of the Food4toddlers eHealth intervention, which aimed to enhance toddlers’ diets by shaping their food and eating environment. Methods The Food4toddlers randomized controlled trial was conducted in Norway in 2017-2018. Parent-child dyads were recruited through social media. In total, 298 parents completed an online questionnaire at baseline (mean child age 10.9 months, SD 1.2). Postintervention questionnaires were completed immediately after the intervention (ie, follow-up 1; mean child age 17.8 months, SD 1.3) and 6 months after the intervention (ie, follow-up 2; mean child age 24.2 months, SD 1.9). The intervention was guided by social cognitive theory, which targets the linked relationship between the person, the behavior, and the environment. The intervention group (148/298, 49.7%) got access to the Food4toddlers website for 6 months from baseline. The website included information on diet and on how to create a healthy food and eating environment as well as activities, recipes, and collaboration opportunities. To assess intervention effects on child diet from baseline to follow-up 1 and from baseline to follow-up 2, we used generalized estimating equations and a time × group interaction term. Between-group differences in changes over time for frequency and variety of fruits and vegetables and frequency of discretionary foods were assessed. Results At follow-up 1, a significant time × group interaction was observed for the frequency of vegetable intake (P=.02). The difference between groups in the change from baseline to follow-up 1 was 0.46 vegetable items per day (95% CI 0.06-0.86) in favor of the intervention group. No other significant between-group differences in dietary changes from baseline to follow-up 1 or follow-up 2 were observed. However, there is a clear time trend showing that the intake of discretionary foods increases by time from less than 1 item per week at baseline to more than 4 items per week at 2 years of age (P<.001), regardless of group. Conclusions A positive intervention effect was observed for the frequency of vegetable intake at follow-up 1 but not at follow-up 2. No other between-group effects on diet were observed. eHealth interventions of longer duration, including reminders after the main content of the intervention has been delivered, may be needed to obtain long-terms effects, along with tailoring in a digital or a personal form. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 92980420; https://doi.org/10.1186/ISRCTN92980420

scholarly journals Process evaluation of ‘Brains Ahead!’: an intervention for children and adolescents with mild traumatic brain injury within a randomized controlled trial

2020 ◽  
Vol 34 (5) ◽  
pp. 688-697
Author(s):  
M Irene Renaud ◽  
Carina Klees ◽  
Jolanda CM van Haastregt ◽  
Coriene E Catsman-Berrevoets ◽  
Ingrid GL van de Port ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Children And Adolescents ◽  
Process Evaluation ◽  
Mild Traumatic Brain Injury ◽  
Controlled Trial ◽  
Intervention Group ◽  
Randomized Controlled ◽  
Study Participants

Objective: To investigate whether the ‘Brains Ahead! Intervention for children and adolescents with mild traumatic brain injury’ was implemented as intended. In addition, involvement in and satisfaction with the intervention among patients, caregivers and professionals delivering the intervention were studied. Design: Mixed methods, prospective study. Participants: Children with mild traumatic brain injury and their caregivers, allocated to the intervention group of the randomized controlled trial in the ‘Brains Ahead!’ study, and the two professionals providing the intervention. Intervention: The intervention consists of a standardized and individualized psychoeducational session with written take-home information, and follow-up telephone call(s). Main measures: Registration forms, evaluation questionnaires for patients and caregivers and semi-structured interviews for professionals. Data analysis: Qualitative data were categorized based on content. Quantitative data were reported as descriptive statistics. Results: Fifty-five patients and caregivers out of 60 study-participants attended both sessions. All elements of the intervention were delivered to 53 study-participants. Evaluation questionnaires were completed by 21 of the 31 patients aged 12 years and older, and by 41 caregivers. Overall, the sessions were considered useful by 19 patients, 40 caregivers and both professionals. Reassurance, creating a better understanding and recognition of symptoms were rated as important aspects. On a scale from 1 to 10, the intervention was rated by children, caregivers and professionals with 7.6 (SD 1.2), 8.1 (SD .9) and 8.0 (SD .0), respectively. Conclusion: The ‘Brains Ahead!’ intervention was largely implemented as intended and the process evaluation revealed that it is considered feasible according to patients, caregivers and professionals.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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