Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Mayer-Davis EJ
PROVIDER: S-EPMC4437823 | biostudies-literature | 2015 Jun
REPOSITORIES: biostudies-literature
Publications
Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial.
Mayer-Davis E J EJ Seid M M Crandell J J Dolan L L Lagarde W H WH Letourneau L L Maahs D M DM Marcovina S S Nachreiner J J Standiford D D Thomas J J Wysocki T T
Diabetic medicine : a journal of the British Diabetic Association 20141230 6
<h4>Aim</h4>To determine the potential effect sizes for the Flexible Lifestyle for Youth (FL3X) behavioural intervention to improve glycaemic control (HbA(1c)) and quality of life for at-risk adolescents with Type 1 diabetes.<h4>Methods</h4>Participants [n = 61; age 12-16 years, HbA(1c) 64-119 mmol/mol (8-13%)] were randomized to FL3X (minimum three sessions) or usual care. Effect sizes (Cohen's d), comparing the mean difference between the groups, were calculated.<h4>Results</h4>Study retention ...[more]
Similar Datasets
Project description:BackgroundPersistent pain in adolescence adversely affects everyday life and is an important public health problem. The primary aim was to determine the feasibility of an 8-week app-based self-management intervention to reduce pain and improve health-related quality of life in a community-based population of adolescents with persistent pain. A secondary aim was to explore differences in health outcomes between the intervention and control groups.MethodsA sample of 73 adolescents aged 16-19 years with persistent pain from a community-based population were randomized into 2 groups. The intervention group received the Norwegian culturally adapted version of the iCanCope with PainTM app, which includes symptom tracking, goal setting, self-management strategies, and social support. The attention control group received a symptom tracking app. Feasibility was assessed as attrition rates and level of engagement (interactions with the app). The secondary outcomes included pain intensity, health-related quality of life, self-efficacy, pain self-efficacy, perceived social support from friends, anxiety and depression, and patient global impression. Statistical analyses were conducted using SPSS.ResultsDemographic and baseline outcome variables did not differ between the 2 groups. No differences were found between the participants completing the study and those who withdrew. Twenty-eight adolescents completed the intervention as planned (62% attrition). Both groups had a low level of app engagement. Intention-to-treat analysis (n = 19 + 14) showed no significant differences in outcomes between groups. However, the large effect size (Cohen's d = .9) for depression suggested a lower depression score in the intervention group.ConclusionsHigh treatment attrition and low engagement indicate the need for changes in trial design in a full-scale randomized controlled trial to improve participant retention.Trial registrationThe iCanCope with Pain Norway trial was retrospectively registered in Clinical Trials.gov (ID: NCT03551977 ). Registered 6 June 2018.
| S-EPMC9327289 | biostudies-literature
Project description:The EYTO-kids (European Youth Tackling Obesity in Adolescents and Children) study aims to increase fruit and/or vegetable consumption and physical activity, decrease sedentary lifestyles, and reduce the intake of sugary drinks and fast food using an innovative methodology based on social marketing and youth involvement. This study is a pilot school-based cluster randomized controlled 10-month intervention spanning two academic years (2015-2016 and 2016-2017), with eight primary schools and three high schools randomized into and designated the control group and eight primary schools and four high schools designated the intervention group in Reus, Spain. At least 301 younger school peers per group should be included. At the intervention high schools, the adolescent creators (ACs) receive an initial 16-h training session. In total, 26-32 high school ACs (12-14 years) from the four high schools will design and implement four health-promotion activities (1 h/each) for their younger (8-10 years), primary school peers. The control group will not receive any intervention. The outcomes (fruit, vegetable, fast food and sugary drink consumption; physical activity; and sedentary behaviors) of the control and intervention groups will be measured pre- and post-intervention. This study describes a protocol for pilot, peer-led, social marketing and youth-involved intervention, where adolescents design and implement activities for their younger peers to promote healthy lifestyles.
| S-EPMC5580625 | biostudies-literature
Project description:BACKGROUND:Youth with disabilities are at high risk of unemployment compared with youth without disabilities. They often encounter challenges in accessing vocational programs that meet their needs. One promising approach that could help to address barriers that youth encounter while also enhancing social support is through electronic mentoring (e-mentoring). Although there is an increase in e-mentoring for youth with disabilities, little is known about its impact for youth with physical disabilities. OBJECTIVE:This study aimed to assess the acceptability and initial impact of a Web-based peer electronic mentor employment intervention for youth with physical disabilities. METHODS:The Empowering Youth Towards Employment intervention was evaluated using a pilot randomized controlled trial (RCT). Youth, aged 15-21 years, with physical disabilities were randomly assigned to an intervention (ie, mentored) or control (ie, not mentored) group. Trained mentors (ie, near peers) with a physical disability led the online discussion forums and provided peer support and resources for 12 modules (1 topic per week over 12 weeks). Primary outcomes focused on self-determination, career maturity, and social support. We also explored program adherence and dosage, participant satisfaction, and areas for improvement. RESULTS:A total of 13 youth (mean age 17.3 years, SD 1.88; 54%, 7/13 female) completed the RCT. In the intervention group (n=9), 56% (5/9) of the youth were females, and in the control group (n=4), 50% (2/4) of the youth were female. Participants reported satisfaction with the program and that it was feasible and acceptable. Participants' mean engagement level with the program was 5.22 (SD 2.48) for the intervention group and 5.40 (SD 4.56) for controls. Participants in the intervention group demonstrated significant improvements in self-determination (t12=2.49; P<.04) compared with the control group. No adverse events were reported. CONCLUSIONS:The Empowering Youth Towards Employment is a promising intervention that enhances self-determination among youth with physical disabilities. TRIAL REGISTRATION:ClinicalTrials.gov NCT02522507; https://clinicaltrials.gov/ct2/show/NCT02522507 (Archived by WebCite at http://www.webcitation.org/6uD58Pvjc). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.2196/resprot.8034.
| S-EPMC6716483 | biostudies-literature
Project description:BACKGROUND:Adolescents with type 1 diabetes commonly have poor glycaemic control. We aimed to test the efficacy of a newly developed adaptive behavioral intervention (Flexible Lifestyles Empowering Change; FLEX) on metabolic and psychosocial outcomes in adolescents with type 1 diabetes. METHODS:Young people (13-16 years, type 1 diabetes duration >1 year, HbA1c of 64-119 mmol/mol [8·0-13·0%], and without other serious medical conditions or pregnancy) from two clinical sites (Colorado and Ohio, USA) were eligible for enrolment. One caregiver was required to participate actively in the study. Adolescent participants were randomly assigned to the FLEX intervention, which used motivational interviewing and problem-solving skills training to enhance patients' self-management, or usual care control. Intervention fidelity was assessed by a behavioral psychologist with specific expertise in motivational interviewing and who was not otherwise involved in the study via audiotaped sessions. The primary outcome was measurement of glycated haemoglobin A1c (HbA1c) at 18 months. Secondary outcomes included motivation and intention, problem solving skills, self-management behaviors, symptoms of depression, health related quality of life, fear of hypoglycemia, diabetes family conflict, risk factors for T1D complications (BMI, blood pressure, and plasma lipids), and hypoglycemia derived from continuous glucose monitoring (percent time below 3·0 and 3·9 mmol/l [54 and 70 mg/dl]). Intention-to-treat analyses used mixed effects models, with fixed effects including site, timepoint, intervention group, intervention by timepoint, and baseline level of primary (HbA1c) or secondary outcomes (?=0·05). FLEX is registered on clinicaltrials.gov, number NCT01286350. FINDINGS:Young people recruited from May 1, 2014 to April 4, 2016 were randomly assigned to FLEX (n=130) or usual care control (n=128). Mean diabetes duration was 6·4 (SD 3·8) years, and 71% (181 out of 256) of patients used insulin pump therapy. Retention was 93%, with 241 out of 258 completing the 18-month assessment. The intervention fidelity score was 4·40 of 5·00 for motivational interviewing and 97% for session content. At 18 months, HbA1c was not significantly different between intervention (83 [13] mmol/mol at baseline; 84 [19] mmol/mol at follow-up); and control (80 [14] mmol/mol at baseline; 82 [17] mmol/mol at follow-up); change in intervention versus control was -0·7 mmol/mol (95% CI -4·7 to 3·4, p=0·75). The intervention was associated with improved scores for motivation (p=0·011), problem solving (p=0·024), diabetes self-management profile (p=0·013), youth report of overall quality of life (p=0·0089), selected domains related to fear of hypoglycaemia (p=0·036 for youth's helplessness or worry; p=0·0051 for parent's efforts to maintain high blood glucose), parent report of diabetes family conflict (p=0·0001), total cholesterol (p=0·038), and diastolic blood pressure (p=0·015). A total of 54 serious adverse events were identified; 34 of these were diabetes-related, including low blood glucose requiring assistance (n=3) and high blood glucose with diabetic ketoacidosis and emergency response (n=25). INTERPRETATION:The FLEX intervention did not significantly change HbA1c among these adolescents with elevated HbA1c, but did positively affect several psychosocial outcomes over 18 months. Further analyses will provide information regarding drivers of positive response to the intervention and will point to future directions for improvement in the approach. FUNDING:National Institutes of Health and National Institute of Diabetes Digestive Diseases and Kidney and the Helmsley Charitable Trust.
| S-EPMC6260973 | biostudies-literature
Project description:BackgroundThree to 22% of youth undergoing surgery develop chronic postsurgical pain (CPSP). Negative biases in pain memories (i.e., recalling higher levels of pain as compared to initial reports) are a risk factor for CPSP development. Children's memories for pain are modifiable. Existing memory-reframing interventions reduced negatively biased memories associated with procedural pain and pain after minor surgery. However, not one study has tested the feasibility and acceptability of the memory-reframing intervention in youth undergoing major surgery.AimsThe current pilot randomized clinical trial (RCT; NCT03110367; clinicaltrials.gov) examined the feasibility and acceptability of, as well as adherence to, a memory reframing intervention.MethodsYouth undergoing a major surgery reported their baseline and postsurgery pain levels. Four weeks postsurgery, youth and one of their parents were randomized to receive control or memory-reframing instructions. Following the instructions, parents and youth reminisced about the surgery either as they normally would (control) or using the memory-reframing strategies (intervention). Six weeks postsurgery, youth completed a pain memory interview; parents reported intervention acceptability. Four months postsurgery, youth reported their pain.ResultsSeventeen youth (76% girls, Mage = 14.1 years) completed the study. The intervention was feasible and acceptable. Parents, but not youth, adhered to the intervention principles. The effect sizes of the intervention on youth pain memories (ηp 2 = 0.22) and pain outcomes (ηp 2 = 0.23) were used to inform a larger RCT sample size.ConclusionsMemory reframing is a promising avenue in pediatric pain research. Larger RCTs are needed to determine intervention efficacy to improve pain outcomes.
| S-EPMC9196744 | biostudies-literature
Project description:BackgroundType 1 diabetes (T1D) affects more than 165,000 individuals younger than 20 years in the United States of America. The transition from parent management to parent-child team management, with the child taking on increased levels of self-care, can be stressful and is associated with a deterioration in self-management behaviors. Therefore, a mobile app intervention, MyT1DHero, was designed to facilitate diabetes-specific positive parent-adolescent communication and improve diabetes-related outcomes. The MyT1DHero intervention links an adolescent with T1D and their parent through 2 separate app interfaces and is designed to promote positive communication regarding T1D management.ObjectiveThe aim of this pilot study was to determine (1) the initial efficacy of the MyT1DHero intervention in improving diabetes outcomes in adolescents, specifically the hemoglobin A1c (HbA1c) levels, diabetes care adherence, and quality of life, and (2) the adolescents' overall satisfaction with this intervention.MethodsThis pilot study included 30 adolescent-parent pairs who used the MyT1DHero app in a 12-week single-arm clinical trial. Participants were recruited from the local pediatric endocrinology subspecialty clinic via snowball sampling. HbA1c levels, diabetes care adherence, quality of life, family conflict, and satisfaction levels were measured and analyzed using paired sample two-sided t tests and linear regression analyses.ResultsThe final analysis included 25 families. The mean age of the adolescents was 12.28 (SD 1.62) years. Half of the participants (13/25) reported a diabetes diagnosis of less than 5 years. After 12 weeks of the intervention, diabetes care adherence significantly improved (before the study: mean 3.87 [SD 0.59]; after the study: mean 4.19 [SD 0.65]; t21=-2.52, P=.02, d=0.52) as did quality of life (before the study: mean 4.02 [SD 0.84]; after the study: mean 4.27 [SD 0.73]; t24=2.48, P=.01, d=0.32). HbA1c levels (before the study: mean 8.94 [SD 1.46]; after the study: mean 8.87 [SD 1.29]; t24=0.67, P=.51, d=0.04) and family conflict (before the study: mean 2.45 [SD 0.55]; after the study: mean 2.61 [SD 0.45]; t23=0.55, P=.14, d=0.32) changed in the hypothesized direction, but the change was not significant. However, higher use of the mobile app was associated with more improvement in HbA1c levels (F1,20=9.74, P<.005; R2=0.33). Overall, the adolescents were satisfied with the app intervention.ConclusionsIn a 12-week pilot study of the mobile app intervention designed to facilitate parent-adolescent communication for improving diabetes outcomes, significant benefits were demonstrated in self-care adherence and quality of life. A randomized controlled trial with a longer intervention is needed to replicate these findings and to determine the stability of the intervention effects.Trial registrationClinicalTrials.gov NCT03436628; https://clinicaltrials.gov/ct2/show/NCT03436628.
| S-EPMC8479605 | biostudies-literature
Project description:Suicide is the second leading cause of death among US adolescents, and rates of suicide among youth have been increasing for the past decade. This study assessed the feasibility and acceptability of the universal, school-based Youth Aware of Mental Health (YAM) program, a promising mental health promotion and suicide primary prevention intervention, in US youth. Using an uncontrolled design, the feasibility and acceptability of delivering and studying YAM were assessed in Montana and Texas schools. Thirteen of 16 (81.3%) schools agreed to support YAM delivery, and five Montana and 6 Texas schools were included in analyses. Facilitators delivered YAM in 78 classes (1,878 students) as regular high school curriculum. Of the total number of students who received YAM, 519 (27.6%) provided parental consent and assent. 436 (84.0%) consented students participated in pre- and post-surveys. Students, parents, and school staff found YAM highly acceptable based on satisfaction surveys. In summary, this study found YAM feasible to implement in US schools. Results also suggest students, parents, and school staff supported school-based programs and were highly satisfied with the YAM program. A randomized controlled trial is warranted to test the efficacy of YAM in promoting mental health and preventing suicidal thoughts and behaviors in US adolescents.
| S-EPMC6942243 | biostudies-literature
Project description:BackgroundHomelessness among youth is devastating, with high rates of substance use disorders and mental health comorbidity. Mindfulness-based interventions that include meditation and mindfulness skills training reduce stress and symptoms of anxiety or depression. However, engaging high-risk youth in interventions is challenging. Virtual reality is a more flexible platform for delivering meditation and may be appealing to youth.ObjectiveThe study objectives were to evaluate the feasibility of delivering virtual reality meditation and of collecting outcome measures, including anxiety and physiologic stress.MethodsA sample of 30 youth experiencing homelessness was enrolled in the study. Youth were randomized to receive 10 minutes of one of three interventions: (1) virtual reality meditation, (2) audio meditation (through a web-based platform), or (3) virtual reality imagery of historical pictures and text. Subjects who consented to the study attended two research visits. The first visit collected survey measures of demographics, mental health, and substance use, and oriented subjects to the intervention platforms. The second visit (1-3 days later) delivered the intervention and collected pre and post outcome measures of anxiety and physiologic stress (salivary cortisol). Changes in anxiety and cortisol at the second visit were compared across groups using a linear regression model in which the primary analysis compared virtual reality meditation to audio meditation and secondary analyses compared virtual reality meditation to virtual reality imagery.ResultsAnxiety scores decreased in all groups, with a larger reduction among the virtual reality meditation group (difference=10.8) compared to the web-based meditation or virtual reality images groups (difference=5.8 and 5.0, respectively). After controlling for baseline values, there were no significant group differences in changes in anxiety scores or cortisol levels. In comparing virtual reality meditation and audio meditation, the effect size for anxiety was moderate (Cohen d=0.58) while the effect size for cortisol was small (Cohen d=0.08).ConclusionsPreliminary results suggest that virtual reality meditation has a moderate benefit for anxiety but not physiologic stress. Future research is needed to confirm these results in a larger sample and to investigate whether the effects are sustained or increase with repeated use of virtual reality mediation. Virtual reality meditation appears feasible to deliver among homeless youth and merits further study.Trial registrationClinicalTrials.gov NCT04004520; https://clinicaltrials.gov/ct2/show/NCT04004520.
| S-EPMC7545327 | biostudies-literature
Project description:BackgroundEncouraging healthy lifestyles in children is a challenge. This project aimed to improve lifestyles of younger peers by engaging adolescent creators (ACs) to design and implement peer-led and social marketing (SM) health-promoting activities.MethodsA 10-month parallel-cluster randomised controlled school-based pilot study was performed in disadvantaged neighbourhoods in Reus (Spain) spanning two academic years (2015-2016/2016-2017). Eight primary schools (n=375 children) and four high schools (n=94ACs) were randomly placed in the intervention group. The 94 ACs (12-14 years) designed and implemented four SM activities for their younger peers (9-11 years). Eight primary schools (n=327 children) and three high schools (n=98 adolescents) served as the control group and received no intervention. Primary (physical activity and fruit consumption) and secondary outcomes (screen time, vegetables, soft drinks, sweets and fast food consumptions) were assessed with validated questionnaires at baseline and at the end of the study.ResultsAfter 10 months, fruit consumption and physical activity were maintained in the children who consumed ≥1 fruit/day and spent ≥6 hours/week physical activity. However, compared with the controls, the intervention significantly increased the physical activity of girls to 15.6 min/week, whereas the percentage of girls who consumed sweets, soft drinks and fast food decreased significantly by 8.4%, 14.5% and 5.9%, respectively. Additionally, the percentage of ≥2 hour/weekday of screen time by boys decreased significantly by 8.2%.ConclusionThe European Youth Tackling Obesity-Kids, SM and peer-led intervention, effectively increased physical activity hours/week in girls, but was not effective in improving the percentage of children who consumed the recommended fruit. Moreover, the percentages of girls who consumed sweets, soft drinks and fast food and boys screen time decreased.Trial registration numberNCT02702336; Pre-results.
| S-EPMC6581153 | biostudies-literature
Project description:Background:Type 1 diabetes is associated with significant mortality and economic cost. Management of type 1 diabetes involves completing multiple daily adherence behaviors, and many adolescents struggle with self-management and show poor glycemic control. Purpose:The purpose was to conduct an unblinded pilot randomized controlled parallel-group study of a web-delivered multicomponent intervention targeting self-monitoring of blood glucose, working memory, and parent supervision of diabetes care among adolescents with type 1 diabetes. Intervention components included high magnitude incentives for adolescents and parents, motivational and cognitive behavioral therapy and working memory training for adolescents, and training in contingency contracting for parents. Methods:Adolescents (N = 114) with poorly controlled type 1 diabetes were screened, and N = 61 were randomized using minimum likelihood allocation to usual care (usual care, N = 31) or to a 25-week/15-session web-delivered intervention (WebRx, N = 30). Results:At the end of treatment, adolescents in WebRx had higher self-monitoring of blood glucose (d = 0.58) (primary outcome), better visual spatial working memory (d = 0.48) and inhibition (d = 0.98), and lower HbA1c (d = 0.45) than those in usual care. WebRx parents reported more frequent review of the adolescent's glucometer (d = 1.30) and reduced family conflict (d = 0.56). Between-condition differences were maintained 6 months later in self-monitoring of blood glucose (d = 0.42), visual spatial working memory (d = 0.76), family conflict (d = 0.50), and HbA1c (d = 0.44). Conclusions:Results showing sustained effects on self-monitoring of blood glucose and HbA1c support moving forward with a larger trial to test this innovative web-delivered and multicomponent intervention. ClinicalTrials.gov Number (NCT01722643).
| S-EPMC6230973 | biostudies-literature