Dataset Information

Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial.

ABSTRACT:

Aim

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.

Methods

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.

Results

Study retention (95%), attendance at intervention sessions (87% attended all three sessions) and acceptability were high (100% of the adolescents and 91% of parents would recommend the programme to others). Overall, 41% of participants in the intervention group and 24% of participants in the control group were 'responders' [HbA(1c) decreased by > 6 mmol/mol (0.5%); d = 0.37]. HbA(1c) levels decreased (d = -0.18), diabetes-specific quality of life increased (d = 0.29), but generic quality of life decreased (d = -0.23) in the intervention compared with the control group.

Conclusions

The FL3X programme merits further study for improving HbA(1c) and diabetes-specific quality of life in adolescents with Type 1 diabetes. (Clinical trials registry no.: NCT01286350).

SUBMITTER: Mayer-Davis EJ

PROVIDER: S-EPMC4437823 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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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]

PMID: 25424501

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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.

Project description:BackgroundYouth 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.ObjectiveThis study aimed to assess the acceptability and initial impact of a Web-based peer electronic mentor employment intervention for youth with physical disabilities.MethodsThe 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.ResultsA 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.ConclusionsThe Empowering Youth Towards Employment is a promising intervention that enhances self-determination among youth with physical disabilities.Trial registrationClinicalTrials.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.

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 (α=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.

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.

Dataset Information

Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial.

Aim

Methods

Results

Conclusions

Publications

Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial.

Similar Datasets

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