Pilot Trial of a Sleep-Promoting Intervention for Children With Type 1 Diabetes.
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ABSTRACT: Objective
To assess the feasibility and acceptability of an educational sleep-promoting intervention (Sleep Coach Jr.) for school-aged children (ages 5-9) with type 1 diabetes (T1D) and their parents.Methods
Parents and children (N = 39 dyads, mean child age = 8 years, 64% girls,) were randomized to either the Sleep Coach Jr. intervention, consisting of educational materials and three individual phone calls (N = 20), or the Standard Care condition (N = 19). Data were collected at enrollment and 3 months later. Children and parents wore actigraphy devices to obtain an objective measure of sleep characteristics, and parents completed questionnaire measures of sleep quality and psychosocial outcomes. Clinical data (i.e., hemoglobin A1c, glucose data) were obtained from children's medical records.Results
Feasibility and acceptability of the study were demonstrated to be high; all three sessions were completed by 80% of parents randomized to the Sleep Coach Jr. intervention, and 90% of parents completed follow-up data at 3 months. Parents reported high levels of satisfaction with the study and identified barriers to participation. No changes were observed in children's sleep or diabetes outcomes, but parental sleep quality and well-being improved.Conclusions
A brief, behavioral sleep-promoting intervention is feasible and acceptable for school-aged children with T1D and their parents. A larger trial is needed to evaluate efficacy of the intervention.
SUBMITTER: Jaser SS
PROVIDER: S-EPMC8679215 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundTeens with type 1 diabetes (T1D) experience increased sleep disturbances, which have been linked to problems with adherence and glycemic control. As such, sleep represents a novel target to improve outcomes in teens.ObjectiveTo evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention in teens with T1D.Research design and methodsTeens aged 13 to 17 with T1D (n = 39) completed measures of sleep quality and diabetes management and wore actigraphs to obtain an objective measure of sleep. Hemoglobin A1C (HbA1c) was collected from medical records. Teens were randomized to Usual Care (n = 19) or the Sleep Coach intervention (n = 20). Teens in the Sleep Coach group received educational materials on healthy sleep habits and completed three individual telephone sessions. Follow-up data were collected at 3 months, including exit interviews with teens and parents.ResultsFeasibility of the study was excellent; 80% of teens in the Sleep Coach group completed all three sessions, and retention was high (90%). Based on actigraphy data, a significant improvement in sleep efficiency and sleep duration was observed (48-minute increase) among teens randomized to the Sleep Coach intervention, and teens in the control group were 7.5 times more likely to report poor sleep quality after 3 months than intervention participants. No change in HbA1c was observed.ConclusionsThe Sleep Coach intervention for teens with T1D is a feasible and acceptable program that increased sleep duration and improved sleep quality for this high-risk population.
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Project description:BackgroundType 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity.MethodsThis was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3-6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat.ResultsThis study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight -0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference -4.2 ± 4.8 vs. 0.7 ± 4.2, p < 0.01; BMI -0.2 ± 0.8 vs. 0.6 ± 1.6, p = 0.05). There were no between group differences in fasting blood glucose, postprandial blood glucose, insulin resistance or any other factors related to diabetes risk or psychological well-being. There were significant reductions in systolic and diastolic blood pressure, total cholesterol, anxiety, depression, negative affect and perceived stress in both the yoga intervention and walking control over the course of the study.ConclusionAmong Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being.Trial registrationClinicalTrials.gov Identified NCT00090506.
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Project description:IntroductionType 2 diabetes is prevalent among US adults. Lifestyle interventions that modify health behaviours prevent or delay progression to diabetes among individuals at high risk. Despite the well-documented influence of individuals' social context on their health, evidence-based type 2 diabetes prevention interventions do not systematically incorporate participants' romantic partners. Involving partners of individuals at high risk for type 2 diabetes in primary prevention may improve engagement and outcomes of programmes. The randomised pilot trial protocol described in this manuscript will evaluate a couple-based lifestyle intervention to prevent type 2 diabetes. The objective of the trial is to describe the feasibility of the couple-based intervention and the study protocol to guide planning of a definitive randomised clinical trial (RCT).Methods and analysisWe used community-based participatory research principles to adapt an individual diabetes prevention curriculum for delivery to couples. This parallel two-arm pilot study will include 12 romantic couples in which at least one partner (ie, 'target individual') is at risk for type 2 diabetes. Couples will be randomised to either the 2021 version of the CDC's PreventT2 curriculum designed for delivery to individuals (six couples), or PreventT2 Together, the adapted couple-based curriculum (six couples). Participants and interventionists will be unblinded, but research nurses collecting data will be blinded to treatment allocation. Feasibility of the couple-based intervention and the study protocol will be assessed using both quantitative and qualitative measures.Ethics and disseminationThis study has been approved by the University of Utah IRB (#143079). Findings will be shared with researchers through publications and presentations. We will collaborate with community partners to determine the optimal strategy for communicating findings to community members. Results will inform a subsequent definitive RCT.Trial registration numberNCT05695170.
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Project description:BackgroundRising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web.ObjectiveThe objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes.MethodsWe conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention.ResultsGeneral practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation.ConclusionsRecruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS.Trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI).
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Project description:BackgroundThis study aimed to assess the effects of digital storytelling on the self-management behavior of adolescents with type 1 diabetes (TID).MethodsIn this pilot randomized controlled clinical trial, 60 adolescents with TID were randomly allocated into two parallel groups: intervention (training with digital storytelling method, n = 33) or control (training with a conventional method, n = 33). The primary outcome was assessing the Self-Management behavior of adolescents with TID (SMOD-A) at baseline and three months after the intervention.ResultsThe results revealed that digital storytelling could significantly improve self-management behaviors amongst adolescents with TID (P = 0.005). In contrast, in the control group, no significant changes were observed (P > 0.05). Furthermore, the mean score of Collaboration with Parents subscale was significantly higher in the digital storytelling group than in the control group after the intervention (p = 0.022). The results also showed that the level of Collaboration With Parents' subscale scores had a meaningful reverse relationship with the adolescent age after digital storytelling (p = 0.048). Repeated measures ANOVAs showed that there were significant main effects of time and group on collaboration with parents(p = 0.002) and goal subscales (p = 0.035). With respect to HbA1c levels, significant changes were not observed in any of the groups (P > 0.05).ConclusionsDigital storytelling is practicable and a potentially beneficial training modality for adolescents with TID.Trial registrationThis trial was respectively registered.Clinicaltrialsgov Identifier: IRCT20191220045828N1 . Date of registration: Oct 29. 2020.
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Project description:BackgroundPhysical activity decreases risk of colon polyps and colon cancer and might reduce risk of colon cancer recurrence. Focusing on recent calls for translation of epidemiologic evidence into clinical care, our pilot study delivered an evidence-based physical activity intervention in adults with polyps, who are thus at elevated risk of developing colon cancer. The objective was to evaluate change in physical activity, measured by steps per day and minutes of moderate/vigorous physical activity.MethodsSixteen adults with adenomas detected and removed at screening colonoscopy were recruited to a 12-week physical activity intervention. Participants were randomized to receive a standard (30 minutes/day) or high (60 minutes/day) walking program. Physical activity was measured via blinded pedometer and accelerometer at baseline and follow-up. Intervention messages focused on self-monitoring using pedometers and overcoming barriers to engaging in physical activity.ResultsParticipants in both arms significantly increased objectively measured minutes of moderate/vigorous physical activity over the course of the intervention. Both arms exceeded the intervention goal, but there was not a significant difference between arms at follow-up. Results were similar for pedometer measured physical activity, with a significant overall increase in steps/day from baseline to follow-up, but no between arm difference in change.ConclusionSimple interventions of minimal contact time focusing on walking can significantly increase physical activity in individuals at increased risk of developing colon cancer.Trial registrationClinicalTrials.gov NCT01476631.
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Project description:BackgroundThe transition of young adults with type 1 diabetes (T1D) from pediatric to adult care is challenging and frequently accompanied by worsening of diabetes-related health. To date, there are no reports which prospectively assess the effects of theory-based psycho-behavioral interventions during the transition period neither on glycemic control nor on psychosocial factors that contribute to poor glycemic control. Therefore, the overall aim of this study was to develop and pilot test an integrative group intervention based on the underlying principles of self-determination theory (SDT), in young adults with T1D.MethodsFifty-one young adults with T1D participated in an education and case management-based transition program, of which 9 took part in the Diabetes Empowerment Council (DEC), a 12-week holistic, multimodality facilitated group intervention consisting of "council" process based on indigenous community practices, stress-reduction guided imagery, narrative medicine modalities, simple ritual, and other integrative modalities. Feasibility, acceptability, potential mechanism of effects, and bio-behavioral outcomes were determined using mixed qualitative and quantitative methods.ResultsThe intervention was highly acceptable to participants, though presented significant feasibility challenges. Participants in DEC showed significant reductions in perceived stress and depression, and increases in general well-being relative to other control participants. Reduction in perceived stress, independent of intervention group, was associated with reductions in hemoglobin A1C. A theoretical model explaining the effects of the intervention included the promotion of relatedness and autonomy support, 2 important aspects of SDT.ConclusionsThe DEC is a promising group intervention for young adults with T1D going through transition to adult care. Future investigations will be necessary to resolve feasibility issues, optimize the multimodality intervention, determine full intervention effects, and fully test the role of the underlying theoretical model of action.ClinicalTrials.gov Registration Number NCT02807155; Registration date: June 15, 2016 (retrospectively registered).
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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).
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Project description:BackgroundDiabetes distress among adolescents with type 1 diabetes has been associated with suboptimal diabetes outcomes, including lower quality of life, increased diabetes self-management challenges, and suboptimal glycemic outcomes.ObjectiveThis study examined the feasibility and acceptability of a scalable self-led mindfulness-based intervention to reduce diabetes distress in adolescents with type 1 diabetes.MethodsAdolescents (N=25) aged between 14 and 18 years diagnosed with type 1 diabetes completed a baseline assessment. Participants were randomized to receive a 10-week self-guided mindfulness-based stress reduction workbook program (e-book or paper option) immediately (n=15) or after a 10-week wait (n=10). During the intervention period, participants completed weekly assignments and feedback surveys. At 10 weeks and 20 weeks, follow-up assessments were completed.ResultsFindings indicated that participants did not find the original intervention feasible or acceptable. Adolescents reported barriers to completing the weekly material, such as that they forgot or that the material was not sufficiently related to their diabetes management. Adolescents also reported that a digital format rather than a workbook or e-book may be more acceptable. Results from weekly surveys provided the foundation for recommendations for future iterations of the mindfulness-based intervention for adolescents with type 1 diabetes.ConclusionsParticipant feedback informed recommendations for self-led mindfulness programs for youth with type 1 diabetes. Adolescents indicated that a shorter, digital mindfulness-based intervention focused on diabetes-specific behaviors may be more helpful.Trial registrationClinicalTrials.gov NCT05115175; https://clinicaltrials.gov/study/NCT05115175.
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Project description:BackgroundUncontrolled type 2 diabetes mellitus (T2DM) may lead to microvascular complications (nephropathy, retinopathy, and neuropathy) and cardiovascular diseases. The beta-glucan content in grains has the potential to improve insulin sensitivity, lowering postprandial glucose response and reducing inflammation degrees. A proper combination of grains not only satisfies human body's need, but also provides essential and reasonable nutritional contents. However, no trial has been conducted to evaluate the roles of multigrain in T2DM.AimTo determine the efficacy of multigrain supplementation among T2DM patients.MethodsFrom October 2020 to June 2021, a total of 50 adults living with T2DM, who were receiving standard diabetes care at Day Care Clinic, were randomized into either a supplementation group or a control group. The supplementation group received twice daily 30 g multigrain supplement (equivalent to 3.4 g beta-glucan) with standard medication for 12 wk, while the control group was prescribed with standard medication. Parameters such as glycemic control (HbA1c, FPG, and HOMO-IR), cardiometabolic profile (lipid profile, renal function test, and liver function test), oxidative stress status, nutritional status, and quality of life (QoL) were assessed at two time points: Baseline and the end of the treatment period (week 12).ResultsThe primary outcomes were the mean difference of glycated haemoglobin (%), fasting plasma glucose, and serum insulin as intervention effects. Secondary outcomes included the measurement of cardiometabolic profile, antioxidative and oxidative stress status, nutritional status indices, and QoL. Tertiary outcomes involved the determination of safety and tolerability, and supplementation compliance.ConclusionThe present clinical trial will reveal the effectiveness of multigrain supplementation among T2DM patients for the improvement of diabetes management.
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