A Pragmatic Randomized Controlled Trial Targeting Perfectionism in Young Adolescents
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ABSTRACT: Supplementary Information
The online version contains supplementary material available at 10.1007/s12310-022-09540-3.
SUBMITTER: Osenk I
PROVIDER: S-EPMC9446653 | biostudies-literature | 2022 Sep
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe onset of puberty is a pivotal period of human development that is associated with significant changes in cognitive, social, emotional, psychological, and behavioral processes that shape identity formation. Very early adolescence provides a critical opportunity to shape identity formation around gender norms, attitudes, and beliefs before inequitable gender norms are amplified during and after puberty.ObjectiveThe aim of the Discover Learning Project is to integrate strategic insights from developmental science to promote positive transformation in social, emotional, and gender identity learning among 10- to 11-year-olds in Tanzania. Through a pragmatic randomized controlled trial, the intervention scaffolds the development of critical social and emotional mindsets and skills (curiosity, generosity, persistence, purpose, growth mindset, and teamwork) delivered by conducting 18 after-school, technology-driven, experiential learning sessions in small, mixed-gender groups.MethodsThe Discover Learning Intervention is a 3-arm randomized controlled trial that will be delivered to 579 participants selected from four public primary schools in Temeke District, Dar es Salaam, Tanzania. Randomization will be done at the individual level into 3 treatment groups receiving incremental intervention components. The treatment components include Discover Learning content curated into child-friendly videos, facilitated discussions, and a parent-child workbook, to be implemented over two phases, each 6 weeks long. A baseline survey will be administered to participants and their parents prior to the intervention. The process will be observed systematically, and data will be collected using surveys, in-depth interviews, observations, and focus group discussions with adolescents, parents, teachers, and facilitators conducted prior, during, and after each implementation phase.ResultsThis study builds on formative and pilot studies conducted with the target population to inform the design of the intervention. The results will generate new evidence that will inform strategies for achieving scale in Tanzania and provide insights for replication of similar programs that are invested in gender-transformative interventions in peri-urban, low-resource settings.ConclusionsThe Discover Learning Intervention makes an important contribution to the field of adolescent developmental science as an intervention designed for very young adolescents in a low-resource setting.Trial registrationClinicalTrials.gov NCT04458077; https://clinicaltrials.gov/ct2/show/NCT04458077.International registered report identifier (irrid)DERR1-10.2196/23071.
| S-EPMC7808886 | biostudies-literature
Project description:BackgroundGiven the global prevalence of insufficient physical activity (PA), effective interventions that attenuate age-related decline in PA levels are needed. Mobile phone interventions that positively affect health (mHealth) show promise; however, their impact on PA levels and fitness in young people is unclear and little is known about what makes a good mHealth app.ObjectiveThe aim was to determine the effects of two commercially available smartphone apps (Zombies, Run and Get Running) on cardiorespiratory fitness and PA levels in insufficiently active healthy young people. A second aim was to identify the features of the app design that may contribute to improved fitness and PA levels.MethodsApps for IMproving FITness (AIMFIT) was a 3-arm, parallel, randomized controlled trial conducted in Auckland, New Zealand. Participants were recruited through advertisements in electronic mailing lists, local newspapers, flyers posted in community locations, and presentations at schools. Eligible young people aged 14-17 years were allocated at random to 1 of 3 conditions: (1) use of an immersive app (Zombies, Run), (2) use of a nonimmersive app (Get Running), or (3) usual behavior (control). Both smartphone apps consisted of a fully automated 8-week training program designed to improve fitness and ability to run 5 km; however, the immersive app featured a game-themed design and narrative. Intention-to-treat analysis was performed using data collected face-to-face at baseline and 8 weeks, and all regression models were adjusted for baseline outcome value and gender. The primary outcome was cardiorespiratory fitness, objectively assessed as time to complete the 1-mile run/walk test at 8 weeks. Secondary outcomes were PA levels (accelerometry and self-reported), enjoyment, psychological need satisfaction, self-efficacy, and acceptability and usability of the apps.ResultsA total of 51 participants were randomized to the immersive app intervention (n=17), nonimmersive app intervention (n=16), or the control group (n=18). The mean age of participants was 15.7 (SD 1.2) years; participants were mostly NZ Europeans (61%, 31/51) and 57% (29/51) were female. Overall retention rate was 96% (49/51). There was no significant intervention effect on the primary outcome using either of the apps. Compared to the control, time to complete the fitness test was -28.4 seconds shorter (95% CI -66.5 to 9.82, P=.20) for the immersive app group and -24.7 seconds (95% CI -63.5 to 14.2, P=.32) for the nonimmersive app group. No significant intervention effects were found for secondary outcomes.ConclusionsAlthough apps have the ability to increase reach at a low cost, our pragmatic approach using readily available commercial apps as a stand-alone instrument did not have a significant effect on fitness. However, interest in future use of PA apps is promising and highlights a potentially important role of these tools in a multifaceted approach to increase fitness, promote PA, and consequently reduce the adverse health outcomes associated with insufficient activity.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12613001030763; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12613001030763 (Archived by WebCite at http://www.webcitation.org/6aasfJVTJ).
| S-EPMC4642788 | biostudies-literature
Project description:Fecal untargeted metabolome analysis of patients with chronic diarrhea.
2024-07-10 | MSV000095296 | MassIVE
Project description:In this trial, patients who agreed to random assignment were allocated to a randomized acupuncture group (R-acupuncture group) or control group. Those who declined randomization were assigned to a nonrandomized acupuncture group (NR-acupuncture group). Patients in the R-acupuncture group and NR-acupuncture group received up to 21 acupuncture sessions during a period of 6 weeks plus routine care, while the control group received routine care alone. Cognitive function, activities of daily living, and quality of life were assessed by mini-mental state examination (MMSE), Activities of Daily Living Scale (ADL), and dementia quality of life questionnaire (DEMQOL), respectively. All the data were collected at baseline, after 6-week treatment, and after 4-week follow-up. No significant differences of MMSE scores were observed among the three groups but pooled-acupuncture group had significant higher score than control group. Compared to control group, ADL score significantly decreased in NR-acupuncture group and pooled-acupuncture group. For DEMQOL scores, no significant differences were observed among the three groups, as well as between pooled-acupuncture group and control group. Additional acupuncture to routine care may have beneficial effects on the improvements of cognitive status and activities of daily living but have limited efficacy on health-related quality of life in VaD patients.
| S-EPMC4606072 | biostudies-other
Project description:BackgroundDisordered eating (DE) is a widespread, serious problem. Efficacious prevention programs that can be delivered at-scale are needed.MethodsA pragmatic randomized controlled trial of two online programs was conducted. Participants were young-adult women from Australia and New Zealand seeking to improve their body image. Media Smart-Targeted (MS-T) and Student Bodies (SB) were both 9-module interventions released weekly, whilst control participants received positive body image information. Primary [Eating Disorder Examination-Questionnaire (EDE-Q) Global], secondary (DE risk factors) and tertiary (DE) outcome measures were completed at baseline, post-program, 6- and 12-month follow-up.ResultsBaseline was completed by 608 women (M age = 20.71 years); 33 were excluded leaving 575 randomized to: MS-T (N = 191); SB (N = 190) or control (N = 194). Only 66% of those randomized to MS-T or SB accessed the intervention and were included in analyses with controls; 78% of this sample completed measures subsequent to baseline. Primary intent-to-treat (ITT) analyses revealed no differences between groups, while measure completer analyses found MS-T had significantly lower EDE-Q Global than controls at 12-month follow-up. Secondary ITT analyses found MS-T participants reported significantly higher quality of life-mental relative to both SB and controls (6-month follow-up), while MS-T and controls had lower clinical impairment relative to SB (post-program). Amongst measure completers, MS-T scored significantly lower than controls and SB on 5 variables. Of those with baseline DE, MS-T participants were significantly less likely than controls to have DE at 12-month follow-up.ConclusionsGiven both programs were not therapist-moderated, MS-T has potential to achieve reductions in DE risk at low implementation costs.
| S-EPMC6171351 | biostudies-literature
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
2024-06-13 | PXD046061 | Pride
Project description:<p>Synbiotics may modulate gut microbiota and prevent infections. In a randomized controlled trial (NCT01625273) infants weaned from breast milk were fed formula with prebiotics (fructo- and galactooligosaccharides) or the same prebiotic formula with <em>Lactobacillus paracasei ssp. paracasei</em> strain F19 (synbiotics) from 1 until 6 months of age. The objective was to examine synbiotic effects on gut microbiota maturation. Fecal samples collected at ages 1, 4, 6 and 12 months (324 samples for microbial and 197 samples for metabolic characterization) were analyzed. We demonstrate enrichment of Bifidobacterium and increases in antimicrobial metabolites derived from microbial fermentation of phenylalanine and pectins in the synbiotic group. The gut microbiota of infants with lower respiratory tract infections (LRTI) were depleted of Lactobacillales but enriched in Klebsiella species and associated antimicrobial resistance genes. These compositional and functional changes of the gut microbiota may be linked to the previously reported reduction of LRTI in the synbiotic group.</p>
2022-11-24 | MTBLS2438 | MetaboLights
Project description:ObjectiveThe aim of the study was to evaluate the short and long-term effects of acupuncture on vasomotor symptoms (VMS) and quality of life-related measures.MethodsA total of 209 perimenopausal and postmenopausal women aged 45 to 60 years, experiencing four or more VMS per day, were recruited from the community and randomized to receive up to 20 acupuncture treatments within the first 6 months (acupuncture group) or the second 6 months (waitlist control group) of the 12-month study period. The primary outcome was mean daily frequency of VMS. Secondary outcomes were VMS interference with daily life, sleep quality, depressive symptoms, somatic and other symptoms, anxiety, and quality of life.ResultsThe VMS frequency declined by 36.7% at 6 months in the acupuncture group and increased by 6.0% in the control group (P < 0.001 for between-group comparison). At 12 months, the reduction from baseline in the acupuncture group was 29.4% (P < 0.001 for within-group comparison from baseline to 12 months), suggesting that the reduction was largely maintained after treatment. Statistically significant clinical improvement was observed after three acupuncture treatments, and maximal clinical effects occurred after a median of eight treatments. Persistent improvements were seen in many quality of life-related outcomes in the acupuncture group relative to the control group.ConclusionsWe found that a course of acupuncture treatments was associated with significant reduction in VMS, and several quality-of-life measures, compared with no acupuncture, and that clinical benefit persisted for at least 6 months beyond the end of treatment.
| S-EPMC4874921 | biostudies-literature
Project description:IntroductionHockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months.MethodsMale fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health.ResultsEighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months.ConclusionsResults suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.
| S-EPMC5704649 | biostudies-literature
Project description:BackgroundAdolescents and young adults (AYA) have an increased risk for Internet use disorders (IUD) compared to older individuals that may lead to functional impairments in daily life. To date, evidence-based brief interventions are lacking. This study aimed to test the efficacy of a low-threshold counseling approach based on Motivational Interviewing (MI) in a vocational school setting.MethodsOf 8.230 vocational students (age M=20.56, SD=4.68; 51.85% female) being proactively screened for IUD, 937 with positive screenings took part in telephone-based diagnostic interviews. IUD were assessed in line with the criteria of the Internet Gaming Disorder in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Readiness to change, self-efficacy, and impairments in daily life were additionally assessed with standardized screening instruments. Participants fulfilling at least two IUD criteria were randomized to the intervention group (n=240, up to three MI-based counseling sessions via telephone) or the control group (n=257, information brochure on responsible Internet use). Follow-up interviews were conducted after five and ten months. The primary outcome was the reduction of IUD criteria. Secondary outcomes were improvements of readiness/ self-efficacy to change and the reduction of daily impairments. Data were analyzed with Intention-to-Treat (ITT) and complier average causal effect (CACE) analyses.ResultsOverall, 153 (63.75%) individuals assigned to the intervention group participated at least in one counseling session (=compliers). Both groups reduced the number of IUD criteria over time. In ITT analyses, however, we did not find intervention effects for primary and secondary outcomes. Bayes statistics were inconclusive. Based on low participation rates in the intervention group, explorative CACE analyses were conducted to compare compliers in the intervention group to potential compliers in the control group. Again, we did not find intervention effects apart from improvements in self-efficacy after five months.DiscussionTelephone-based counseling seems not appropriate to address AYA at risk for IUD. Low participation rates in the intervention group caused underpowered analyses. Besides, dealing with the own Internet use during intensive assessments and receiving an information brochure led to behavioral changes also in the control group. Since the efficacy of brief interventions under the condition of higher participation rates cannot be fully ruled out, further research is required by taking the implications of this study into account.
| S-EPMC9872541 | biostudies-literature