Design of the FINS-TEENS study: A randomized controlled trial assessing the impact of fatty fish on cognitive performance in adolescents

2017 ◽  
Vol 45 (6) ◽  
pp. 621-629 ◽  
Author(s):  
Siv Skotheim ◽  
Lisbeth Dahl ◽  
Katina Handeland ◽  
Livar Frøyland ◽  
Øyvind Lie ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Randomized Controlled Trial ◽  
Cognitive Performance ◽  
Controlled Trial ◽  
Fatty Fish ◽  
Post Intervention ◽  
Dietary Compliance ◽  
Randomized Controlled ◽  
Study Results ◽  
The Impact

Aims: To describe the rationale, study design, population and dietary compliance in a randomized controlled trial (RCT) investigating the effect of fatty fish on cognitive performance and mental health in adolescents. Method: In the Fish Intervention Studies-TEENS (FINS-TEENS) study we individually randomized 478 adolescents (14–15-year-olds) from eight secondary schools in Norway to receive school meal lunches with fatty fish or meat or n-3 supplements three times a week for 12 weeks. Demographic factors, psychological tests and biological measures were collected pre-and post-intervention. Duplicate portions of lunch meals were collected and individual intake recorded throughout the study. Results: In total, 481 out of 785 adolescents (61%) agreed to participate and 34 (7%) dropped out. Breakfast consumption was the only group difference in background characteristics. Analyses of selected nutrients in the lunch meals showed higher levels of n-3 fatty acids, vitamin D and n-6 fatty acids in the fish compared to the meat meals. Dietary compliance (score 0–144) revealed that the intake in the Fish group (mean = 59, standard deviation (SD) = 35) were lower than in the Meat group (mean = 83, SD = 31, p < 0.01) and Supplement group (mean = 105, SD = 25, p < 0.01). Conclusions: The results show that it is possible to conduct a RCT with fatty fish in a school-based setting. The results also emphasize the importance of collecting detailed records of dietary compliance, as this information is important when interpreting and analysing the outcome of dietary interventions.

scholarly journals Fatty Fish Intake and the Effect on Mental Health and Sleep in Preschool Children in FINS-KIDS, a Randomized Controlled Trial

Nutrients ◽  
2018 ◽  
Vol 10 (10) ◽  
pp. 1478 ◽  
Author(s):  
Mari Hysing ◽  
Ingrid Kvestad ◽  
Marian Kjellevold ◽  
Lisa Kolden Midtbø ◽  
Ingvild Graff ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Sleep Problems ◽  
Controlled Trial ◽  
Parent Report ◽  
Fatty Fish ◽  
Post Intervention ◽  
Dietary Compliance ◽  
Randomized Controlled

Mental health and sleep problems are prevalent in children during preschool years. The aim of the current study was to investigate if increased intake of fatty fish compared with meat improves mental health and sleep in four- to six-year-old children. The children (n = 232) in the two-armed randomized controlled trial, Fish Intervention Studies-KIDS (FINS-KIDS), were randomly assigned to lunch meals with fatty fish (herring/mackerel) or meat (chicken/lamb/beef) three times a week for 16 weeks. The fish and meat were weighed before and after the meals to record the exact consumption in grams (dietary compliance). Mental health problems were assessed by the strengths and difficulties questionnaire (SDQ) and sleep by parent report pre- and post-intervention. There was no significant statistical difference between changes in mental health and sleep for the fish eating group compared with the meat eating group, neither in the crude analysis nor after adjusting for intake of fish or meat (dietary compliance).

Effect of n-3 long-chain polyunsaturated fatty acids supplementation in healthy mothers on DHA and EPA profiles in maternal and umbilical blood: a randomized controlled trial

2019 ◽  
Vol 47 (2) ◽  
pp. 200-206
Author(s):  
Dragan Soldo ◽  
Matija Mikulić-Kajić ◽  
Lara Spalldi Barišić ◽  
Nikolina Penava ◽  
Martina Orlović ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Randomized Controlled Trial ◽  
Corn Oil ◽  
Controlled Trial ◽  
Lipid Extraction ◽  
Control Group ◽  
Randomized Controlled ◽  
Umbilical Blood ◽  
Epa And Dha ◽  
The Impact

AbstractBackgroundThe objective of the study was to compare the effect of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) dietary supplementation on their concentration in total lipids (TL) and lipid fractions of maternal and umbilical vein (UV) blood. The specific objective was to analyze the impact of EPA and DHA supplementation on pregnancy outcome and neonatal birth weight.MethodsWomen were randomly single-blinded (randomized controlled trial; ISRCTN36705743) allocated to the group receiving EPA and DHA supplementation (supplemented group) or the group receiving placebo-corn oil (control group) in the time period from January 1st, 2016 until March 1st, 2017. Women in the supplemented group (n=45) took 360 mg EPA and 240 mg DHA daily while controls (n=42) were given a placebo. Maternal and UV bloods were obtained at delivery. After lipid extraction, phospholipids (PL), cholesterol esters (CE), triacylglycerols (TG) and non-esterified fatty acids were separated by thin layer chromatography and analyzed by gas chromatography.ResultsHigher DHA concentrations in TL (37.24±21.87 mg/L), PL (13.14±8.07 mg/L) and triacylglycerols (2.24±2.21 mg/L) were recorded in mothers from the supplemented group when compared to the study group (TL 21.89±14.53 mg/L; P<0.001; PL 9.33±5.70 mg/L; P=0.013; TG 0.56±0.43 mg/L; P<0.001). Higher DHA concentrations in UV samples were found in TL (11.51±7.34 mg/L), PL (5.29±3.31 mg/L) and triacylglycerols (0.62±0.46 mg/L) from the supplemented groups compared with controls (TL 7.37±3.60 mg/L; P=0.002; PL 3.52±2.19 mg/L; P=0.005; TG 0.40±0.46 mg/L; P=0.035). The ratio of AA:DHA was lower in maternal (2.43) and UV serum (4.0) of the supplemented group than in the control group (maternal 3.85 P<0.001; UV 4.91 P<0.001).ConclusionThe study demonstrated the higher ratio of AA/DHA in the control group indicating that pregnant women on the traditional Herzegovina diet need supplementation with DHA and EPA.

Free From Falls education and exercise program for reducing falls in people with multiple sclerosis: A randomized controlled trial

2021 ◽  
pp. 135245852110468
Author(s):  
Michelle H Cameron ◽  
Andrea Hildebrand ◽  
Cinda L Hugos ◽  
Grace I Judd ◽  
Garnett McMillan ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Exercise Program ◽  
Control Group ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Credible Intervals ◽  
Falls In Older Adults ◽  
The Impact

Background: People with multiple sclerosis (PwMS) fall frequently. Community-delivered exercise and education reduce falls in older adults, but their efficacy in multiple sclerosis (MS) is unknown. Objectives: To evaluate the impact of the Free From Falls (FFF) group education and exercise program on falls in PwMS. Methods: This was a prospective, assessor-blinded, two-arm parallel randomized controlled trial. Ninety-six participants were randomized to FFF (eight weekly 2 hour sessions) or the control condition (a fall prevention brochure and informing their neurologist of their fall history). Participants counted falls prospectively from enrollment through 6 months following intervention. Effects on fall frequency were evaluated by the Bayesian analysis. Results: The modeled mean fall frequency pre-intervention was 1.2 falls/month in the FFF group (95% credible intervals (CIs) = 0.8–2.0) and 1.4 falls/month in the control group (95% CI = 0.9–2.1). Fall frequency decreased by 0.6 falls/month in both groups over time (nadir 4–6 months post-intervention: FFF 0.6 falls/month (95% CI = 0.4–0.9); control 0.8 falls/month (95% CI = 0.5–1.1)). Conclusion: In-person group exercise and education are not superior to written education and neurologist-initiated interventions for preventing falls in PwMS.

scholarly journals Group intervention for siblings and parents of children with chronic disorders (SIBS-RCT): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Krister W. Fjermestad ◽  
Wendy K. Silverman ◽  
Torun M. Vatne
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Family Communication ◽  
Neurodevelopmental Disorders ◽  
Group Intervention ◽  
Controlled Trial ◽  
Evidence Based ◽  
Post Intervention ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Siblings and parents of children with neurodevelopmental disorders are at risk of mental health problems and poorer family communication. Some group interventions for siblings exist, but few have clearly described parent components and none are considered evidence-based. Methods We are conducting a randomized controlled trial comparing a five-session manual-based group intervention for siblings (aged 8 to 16 years) and parents of children with neurodevelopmental disorders to a 12-week waitlist, called SIBS-RCT. The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone. The intervention aims at improving parent-child communication and covers themes such as siblings’ understanding of the neurodevelopmental disorder, siblings’ emotions, and perceived family challenges. Participants are recruited through municipal and specialist health centers across Norway. The primary outcome is sibling mental health. Quality of life and family communication are secondary outcomes. Participants are block-randomized to the intervention or 12-week waitlist in groups of six. Measures are collected electronically at pre- and post-intervention/waitlist, as well as 3, 6, and 12 months post-intervention. The main effect to be examined is the difference between the intervention and waitlist at 12 weeks post. All outcomes will also be examined using growth curve analyses. We plan to include 288 siblings and their parents by the end of 2022. Discussion SIBS-RCT represents a major contribution to the research and practice field towards establishing an evidence-based intervention for siblings. In the event that intervention and waitlist are no different, the impact of SIBS-RCT is still substantial in that we will aim to identify participant subgroups that show positive response and effective components of the SIBS manual by examining group leader adherence as an outcome predictor. This will allow us to continue to re-engineer the SIBS manual iteratively to improve outcomes, and avoid the promotion of a less-than-optimal intervention. Trial registration ClinicalTrials.gov NCT04056884. Registered in August 2019

The impact of an empowerment intervention on people with schizophrenia: Results of a randomized controlled trial

2017 ◽  
Vol 63 (3) ◽  
pp. 212-223 ◽  
Author(s):  
Abdalhadi Hasan ◽  
Mahmoud Musleh
Keyword(s):  
Randomized Controlled Trial ◽  
Psychiatric Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Post Intervention ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
The Impact

Aims: The aim of the study was to assess what empowerment intervention has on people with schizophrenia. Methods: A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks’ worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. Results: This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. Conclusion: This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.

scholarly journals The Impact of Shorter, More Frequent Outdoor Play Periods on Preschoolers’ Physical Activity during Childcare: A Cluster Randomized Controlled Trial

2019 ◽  
Vol 16 (21) ◽  
pp. 4126 ◽  
Author(s):  
Molly Driediger ◽  
Stephanie Truelove ◽  
Andrew M. Johnson ◽  
Leigh M. Vanderloo ◽  
Brian W. Timmons ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Outdoor Play ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Children’s physical activity levels are higher at the start of outdoor playtime, which suggests that shorter, more frequent play periods might result in greater amounts of daily physical activity. In this extension of the Supporting Physical Activity in the Childcare Environment (SPACE) cluster randomized controlled trial, we explored the impact of four 30-min daily outdoor unstructured play periods on preschoolers’ moderate-to-vigorous-intensity physical activity (MVPA). Experimental childcare centres (n = 6) implemented four 30-min daily outdoor playtimes for 8 weeks, while control centres (n = 6) maintained their two 60-min outdoor sessions. Actical™ accelerometers were used to measure preschoolers’ physical activity pre- and post-intervention for 5 days during childcare hours. Linear mixed effects models were used to determine the impact of the intervention on preschoolers’ MVPA. Of the 185 preschoolers enrolled (54.20% female; mean age = 39.90 months, SD = 7.24), 127 (65 experimental and 62 control) were included in the analysis (30% and 9% loss to follow-up for experimental and control group preschoolers, respectively). No significant differences in MVPA were observed between groups over time (p = 0.36). Preschoolers’ MVPA did not improve after the introduction of shorter outdoor play periods. The loss of data due to wear time noncompliance and participant attrition may have influenced these findings. Trial registration: ISRCTN70604107 (October 8, 2014).

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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