The effect of individual and mixed rewards on diabetes management: A feasibility randomized controlled trial.
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SUBMITTER: Miranda JJ
PROVIDER: S-EPMC6325609 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundDiabetes mellitus is the third most prevalent chronic metabolic disorder and a significant contributor to disability and impaired quality of life globally. Diabetes self-management coaching is an emerging empowerment strategy for individuals with type 2 diabetes, enabling them to achieve their health and wellness goals. The current study aims to determine the feasibility of a diabetes self-management coaching program and its preliminary effectiveness on the clinical and psychosocial outcomes in the Ethiopian primary healthcare context.MethodsThe study will employ a mixed-method feasibility randomized controlled trial design. Forty individuals with type 2 diabetes will be randomly allocated to treatment and control groups using block randomization. The primary feasibility outcomes include acceptability, eligibility, recruitment, and participant retention rates, which will be computed using descriptive analysis. The secondary outcomes are self-efficacy, self-care activity, quality of life, and glycated hemoglobin A1c. For normally distributed continuous variables, the mean difference within and between the groups will be determined by paired sample Student t-test and independent sample Student t-test, respectively. Non-parametric tests such as the Mann-Whitney U test, the Wilcoxon signed rank test, and the Friedman analysis of variance test will determine the median difference for variables that violated the normality assumption. A repeated measure analysis of variance will be considered to estimate the variance between the baseline, post-intervention, and post-follow-up measurements. A sample of 10 volunteers in the treatment group will participate in the qualitative interview to explore their experience with the diabetes self-management coaching program and overall feasibility. The study will follow a qualitative content analysis approach to analyze the qualitative data. Qualitative and quantitative findings will be integrated using a joint display technique.DiscussionEvidence reveals diabetes self-management coaching programs effectively improve HbA1c, self-efficacy, self-care activity, and quality of life. This study will determine the feasibility of a future large-scale randomized controlled trial on diabetes self-management coaching. The study will also provide evidence on the preliminary outcomes and contribute to improving the diabetes self-management experience and quality of life of individuals with type 2 diabetes.Trial registrationThe trial was registered online at ClinicalTrials.gov on 12/04/2022 and received a unique registration number, NCT05336019, and the URL of the registry is https://beta.Clinicaltrialsgov/study/NCT05336019 .
| S-EPMC11000297 | biostudies-literature
Project description:AIMS:To undertake a feasibility randomized controlled trial of supported self-management vs treatment as usual in a population of adults with obesity, Type 2 diabetes and an intellectual disability. METHODS:We conducted an individually randomized feasibility trial. Participants were adults aged >18 years with a mild or moderate intellectual disability, living in the community with Type 2 diabetes, on any therapy other than insulin. Participants had mental capacity to consent to research and the intervention. Inclusion criteria included HbA1c > 48 mmol/mol (6.5%), BMI >25 kg/m2 , or self-reported physical activity below national guideline levels. The experimental intervention was standardized supported self-management delivered by diabetes specialist nurses plus treatment as usual, compared with treatment as usual alone. Feasibility outcomes included: recruitment and retention; intervention acceptability and feasibility; data collection and completeness for physiological state and values for candidate primary outcomes (HbA1c and BMI). RESULTS:A total of 82 participants (89% of those contacted and eligible) were randomized. All supported self-management sessions were completed by 35/41 participants (85%); only four completed no sessions. Data on the follow-up candidate primary outcomes HbA1c and BMI were obtained for 75/82 (91%) and 77/82 participants (94%), respectively. The mean baseline HbA1c was 56±16.5 mmol/mol (7.3±1.5%) and the mean BMI was 34±7.6 kg/m2 . CONCLUSIONS:Adherence to supported self-management and willingness to have blood taken for outcome measurement was good. A definitive randomized controlled trial is feasible in this population. (Trial registration: Current Controlled Trials ISRCTN41897033).
| S-EPMC5969288 | biostudies-literature
Project description:BackgroundThe role of mobile health care (mHealth) in glycemic control has been investigated, but its impact on self-management skills and its psychological aspects have not been studied.ObjectiveWe evaluated the efficacy of mHealth-based diabetes self-management education and the effect of voluntary participation on its effects.MethodsThis study was a randomized controlled open-label trial conducted for 6 months at Kangbuk Samsung Hospital. Participants in the control group (n=31) maintained their previous diabetes management strategies. Participants in the intervention group (n=41) additionally received mHealth-based diabetes self-management education through a mobile app and regular individualized feedback from health care professionals. The primary outcome was change in glycated hemoglobin (HbA1c) level over 6 months between the 2 groups (intervention versus control) and within each group (at 6 months versus baseline). The secondary outcomes were changes in body mass index, blood pressure, lipid profile, and questionnaire scores (the Korean version of the Summary of Diabetes Self-Care Activities Questionnaire, an Audit of Diabetes Dependent Quality of Life, the Appraisal of Diabetes Scale, and Problem Areas in Diabetes) over 6 months between groups and within each group.ResultsA total of 66 participants completed this study. HbA1c (P=.04), total cholesterol level (P=.04), and Problem Areas in Diabetes scores (P=.02) significantly decreased; total diet (P=.03) and self-monitoring of blood glucose level scores (P=.01), based on the Summary of Diabetes Self-Care Activities Questionnaire, markedly increased within the intervention group. These significant changes were observed in self-motivated participants who were recruited voluntarily via advertisements.ConclusionsmHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.Trial registrationClinicalTrials.gov NCT03468283; http://clinicaltrials.gov/ct2/show/NCT03468283.
| S-EPMC7532462 | biostudies-literature
Project description:BACKGROUND:This randomized, controlled trial evaluated a monetary-based reinforcement intervention for increasing self-monitoring of blood glucose (SMBG) among youth with poorly controlled type 1 diabetes. METHODS:After a 2-week baseline, 60 participants were randomized to enhanced usual care (EUC) or Reinforcers. The Reinforcers group earned monetary rewards for SMBG and associated behaviors such as uploading glucose meters. Reinforcers were withdrawn at 24?weeks. A follow-up evaluation occurred at 36?weeks. RESULTS:Participants in the reinforcers group increased the proportion of days they completed ?4 SMBG from 14.6% at baseline to 64.4%, 47.5%, and 37.8% at 6, 12, and 24?weeks, respectively. In contrast, EUC participants declined from 22.7% at baseline to 17.5%, 10.5%, and 11.1% (Ps?<?.01 vs EUC at all time points). Group differences were attenuated but remained significant after withdrawal of reinforcers. Effect sizes for SMBG were very large during reinforcement and large after withdrawal of reinforcers. In the reinforcers group, mean A1c dropped from 9.5%?±?1.2% at baseline to 9.0%?±?1.3% at week 6 and 9.0%?±?1.4% at week 12. For EUC, A1c was 9.2%?±?0.2% at baseline and ranged from 9.2%?±?1.5% to 9.6%?±?1.6% throughout the study (P?<?.05 vs EUC). Group differences in A1c were no longer significant at weeks 24 and 36. Effect sizes for A1c were small during reinforcement and also after withdrawal of reinforcement. CONCLUSIONS:Monetary-based reinforcement of adolescents with type 1 diabetes caused durable increases in SMBG. Modification of the reinforcement structure may be needed to sustain improved metabolic control in this challenging age group.
| S-EPMC6786915 | biostudies-literature
Project description:BackgroundPoor self-management of heart failure (HF) contributes to devastating health consequences. Our innovative sensor-controlled digital game (SCDG) integrates data from sensors to trigger game rewards, progress, and feedback based on the real-time behaviors of individuals with HF.ObjectiveThe aim of this study is to compare daily weight monitoring and physical activity behavior adherence by older adults using an SCDG intervention versus a sensors-only intervention in a feasibility randomized controlled trial.MethodsEnglish-speaking adults with HF aged 55 years or older who owned a smartphone and could walk unassisted were recruited from Texas and Oklahoma from November 2019 to August 2020. Both groups were given activity trackers and smart weighing scales to track behaviors for 12 weeks. The feasibility outcomes of recruitment, retention, intervention engagement, and satisfaction were assessed. In addition to daily weight monitoring and physical activity adherence, the participants' knowledge, functional status, quality of life, self-reported HF behaviors, motivation to engage in behaviors, and HF-related hospitalization were also compared between the groups at baseline and at 6, 12, and 24 weeks.ResultsA total of 38 participants with HF-intervention group (IG; 19/38, 50%) and control group (CG; 19/38, 50%)-were enrolled in the study. Of the 38 participants, 18 (47%) were women, 18 (47%) were aged 65 years or older, 21 (55%) had been hospitalized with HF in the past 6 months, and 29 (76%) were White. Furthermore, of these 38 participants, 31 (82%)-IG (15/19, 79%) and CG (16/19, 84%)-had both weight monitoring and physical activity data at the end of 12 weeks, and 27 (71%)-IG (14/19, 74%) and CG (13/19, 68%)-participated in follow-up assessments at 24 weeks. For the IG participants who installed the SCDG app (15/19, 79%), the number of days each player opened the game app was strongly associated with the number of days the player engaged in weight monitoring (r=0.72; P=.04) and the number of days with physical activity step data (r=0.9; P<.001). The IG participants who completed the satisfaction survey (13/19, 68%) reported that the SCDG was easy to use. Trends of improvement in daily weight monitoring and physical activity in the IG, as well as within-group improvements in HF functional status, quality of life, knowledge, self-efficacy, and HF hospitalization in both groups, were observed in this feasibility trial.ConclusionsPlaying an SCDG on smartphones was feasible and acceptable for older adults with HF for motivating daily weight monitoring and physical activity. A larger efficacy trial of the SCDG intervention will be needed to validate trends of improvement in daily weight monitoring and physical activity behaviors.Trial registrationClinicalTrials.gov NCT03947983; https://clinicaltrials.gov/ct2/show/NCT03947983.
| S-EPMC8663490 | biostudies-literature
Project description:BackgroundIndividuals with type 2 diabetes (T2D) who smoke are at increased risk for many types of cancers as well as an accelerated progression of microvascular and macrovascular complications. Smoking cessation is recommended as a standard treatment for T2D; however, individuals with T2D are faced with competing lifestyle changes. Glycemic and blood pressure control often take precedence over smoking cessation, and patients are often unmotivated to quit. Contingency management in combination with standard smoking cessation treatment has been demonstrated to improve cessation outcomes in various populations. The purpose of this randomized controlled feasibility trial is to explore the feasibility of contingency management and biochemical verification using a remote smartphone-based carbon monoxide monitor for smoking cessation among individuals with T2D.MethodsA three-arm, randomized controlled feasibility trial will be conducted in two study sites that include the USA and UK. We will recruit 60 participants who will each receive usual care smoking cessation treatment (counseling and nicotine replacement therapy) and be randomized to a short term incentives (6 weeks), long term incentives (12 weeks), or no incentives (control) group. Participants will receive a smartphone and carbon monoxide monitor to complete daily remote assessments throughout the 12 weeks and will complete an exit interview at the end of the study. The primary outcomes for this feasibility study include completion of the protocol and proportion of daily assessments completed. Secondary outcomes include recruitment measures, acceptability, and smoking abstinence.DiscussionWe will explore the feasibility of recruiting smokers with T2D and their engagement in the program, particularly related to the use of the remote biochemical verification and smartphone application. In addition, we will evaluate the intervention content, study procedures, data collection methods, and follow-up and will qualitatively assess the participants' acceptability of the program. The results of this study will inform the design of a larger trial to test the efficacy of the contingency management program for improving smoking cessation outcomes among individuals with T2D.Trial registrationThis randomized controlled feasibility trial has been registered at ClinicalTrials.gov with an ID NCT03527667 on May 4, 2018.
| S-EPMC7291555 | biostudies-literature
Project description:Chronic stress affects many Americans. Stress management programs may be prohibitively expensive or have limited access.This study aims to determine feasibility of an 8-week Internet-based stress management program (ISM) based on mindfulness principles in reducing stress in a 12-week, parallel, randomized, controlled trial.Participants were randomly allocated to ISM, ISM plus online message board (ISM+), or control groups. Perceived stress, mindfulness, self-transcendence, psychological well-being, vitality, and quality of life were measured at baseline, week 8, and week 12 using standard validated questionnaires.ISM and ISM+ groups demonstrated statistically significant improvements compared with control on all measures except vitality and physical health.The ISM program effectively and sustainably reduced measures of stress. The magnitude of improvement is comparable to traditional mindfulness programs, although fewer participants were engaged. This feasibility study provides strong support for online stress management programs, which increase access at a fraction of cost of traditional programs.
| S-EPMC3775158 | biostudies-literature
Project description:IntroductionType 2 diabetes mellitus (T2DM) is a common chronic condition with significant health and socioeconomic consequences. In Nepal, T2DM is a common disease for which people consult ayurvedic (traditional medical system) practitioners and use ayurvedic medicines. Strong concerns remain about the suboptimal T2DM management of many patients by ayurvedic practitioners, and therefore, based on the best available scientific evidence, we have developed a clinical guideline for managing T2DM by ayurvedic practitioners. The research question to be addressed by a definitive cluster randomized controlled trial (RCT) is whether the introduction of a clinical guideline can improve the management of T2DM by ayurvedic practitioners in Nepal as compared to usual ayurvedic management (i.e., without any clinical guideline). In preparation for this future work, this current study aims to determine the feasibility of undertaking the definitive cluster RCT.MethodsThis is a 2-arm, feasibility cluster RCT with a blinded outcome assessment and a qualitative evaluation. The study is conducted in 12 public and private ayurveda centers in and outside the Kathmandu Valley in Nepal (1:1 intervention:control). Eligible participants should be new T2DM adult patients (i.e., treatment naïve) - the glycated hemoglobin level should be 6.5% or above but less than 9%. At least 120 participants (60/group) will be recruited and followed up for 6 months. Important parameters, needed to design the definitive trial, will be estimated, such as the standard deviation of the outcome measure (i.e., glycated hemoglobin level at 6-month follow-up), intraclass correlation coefficient, cluster size, recruitment, the time needed to recruit participants, follow-up, and adherence to the recommended ayurvedic medicine. Semi-structured qualitative interviews will be conducted with around 20 to 30 participants and all the participating ayurvedic practitioners to explore their experiences and perspectives of taking part in the study and of the intervention and a sample of eligible people declining to participate in the study to explore the reasons behind nonparticipation.DiscussionWe are now conducting a feasibility cluster RCT in Nepal to determine the feasibility of undertaking the definitive cluster trial. The first participant was recruited on 17 July 2022. If the feasibility is promising (such as recruitment, follow-up, and adherence to the recommended ayurvedic medicine), then the parameters estimated will be used to design the definitive cluster trial. Decisions over whether to modify the protocol will mainly be informed by the qualitative data.
| S-EPMC9704971 | biostudies-literature
Project description:BackgroundDue to diabetes disparities commonly seen among African Americans, it is important to address psychosocial and sociocultural barriers to medication adherence among African Americans with diabetes. Building on our prior work testing a culturally adapted peer supported diabetes self-management intervention for African Americans, this study will conduct a pilot randomized controlled feasibility trial that compares the culturally adapted intervention with a standard diabetes self-management program.MethodsUsing an intervention mixed-methods design, the six-month trial will be conducted at two sites. Twenty-four African Americans with uncontrolled type 2 diabetes will be randomized to the intervention or control arm. Feasibility and acceptability outcomes in four domains (recruitment, intervention acceptability, intervention adherence, retention) will be collected. Primary clinical outcome (A1C), secondary outcome (medication adherence) and patient-specific psychosocial measures will be collected at baseline, 2 months, and 6 months. Document review, interview and focus groups will be used to gather qualitative data on feasibility and acceptability.ResultsExpected results are that the trial protocol will be feasible to implement and acceptable for participants, and there will be a signal of clinically meaningful reduction in A1C and improvements in medication adherence.ConclusionsThe results of this trial will inform a future powered large-scale randomized controlled trial testing the effectiveness of the culturally tailored intervention.
| S-EPMC9844478 | biostudies-literature
Project description:BackgroundExcessive gestational weight gain (GWG) is common and can result in maternal and child health complications. Pragmatic behavioral interventions that can be incorporated into standard obstetric care are needed, and financial incentives are a promising approach.ObjectiveThe aim of this study is to evaluate the feasibility of recruitment, randomization, and retention, as well as treatment engagement and intervention satisfaction, in a behavioral program. The program provided small incentives for meeting behavioral goals of self-weighing and physical activity as well as larger outcome incentives for meeting GWG goals.MethodsWe recruited 40 adult women in their first trimester of pregnancy from February 2019 to September 2019 at an obstetric clinic. Participants were randomized to 3 intervention components using a 2×2×2 factorial design: daily incentives for self-weighing (lottery vs certain loss), incentives for adhering to the Institute of Medicine's GWG guidelines based on BMI category (monthly vs overall), and incentives for reaching physical activity goals (yes vs no). Participants were asked to complete daily weigh-ins using the Withings Body wireless scale provided by the study, as well as wear a physical activity tracker (Fitbit Flex 2). Feasibility outcomes of recruitment, randomization, and retention, as well as treatment engagement and intervention satisfaction, were assessed. Weight assessments were conducted at baseline, 32-week gestation, and 36-week gestation.ResultsParticipants were enrolled at, on average, 9.6 (SD 1.8) weeks' gestation. Of the 39 participants who were oriented to their condition and received the intervention, 24 (62%) were Black or African American, 30 (77%) were not married, and 29 (74%) had an annual household income of less than US $50,000. Of the 39 participants, 35 (90%) completed the follow-up data collection visit. Participants were generally quite positive about the intervention components, with a particular emphasis on the helpfulness of, and the enjoyment of using, the e-scale in both the quantitative and qualitative feedback. Participants who received the loss incentive, on average, had 2.86 times as many days of self-weighing as those who received the lottery incentive. Participants had a relatively low level of activity, with no difference between those who received a physical activity incentive and those who did not.ConclusionsA financial incentive-based pragmatic intervention was feasible and acceptable for pregnant women for promoting self-weighing, physical activity, and healthy GWG. Participants were successfully recruited early in their first trimester of pregnancy and retained for follow-up data collection in the third trimester. Participants demonstrated promising engagement in self-weighing, particularly with loss-based incentives, and reported finding the self-weighing especially helpful. This study supports further investigation of pragmatic, clinic-based financial incentive-based interventions for healthy GWG behaviors.Trial registrationClinicalTrials.gov NCT03834194; https://clinicaltrials.gov/ct2/show/NCT03834194.
| S-EPMC8742213 | biostudies-literature