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Randomized clinical trial of clinic-integrated, low-intensity treatment to prevent deterioration of disease care in adolescents with type 1 diabetes.

ABSTRACT: To evaluate the efficacy of two office-based treatments designed to prevent deterioration in glycemic control in young adolescents with type 1 diabetes in a randomized clinical trial. An individualized, more intensive family teamwork Coping skills program was compared with a diabetes Education treatment.A baseline assessment was followed by four brief treatment sessions and immediate posttesting over the course of 1.5 years. Families of 226 early adolescents (ages 11-14) were randomized to receive either individualized coping skills education or diabetes education as adjunctive treatment to quarterly medical appointments. Continued follow-up occurred at 3.5-month intervals for a long-term follow-up of up to 3 years. A post hoc Usual Care group facilitated comparisons of glycemic control.Growth curve analysis showed that both treatment groups successfully prevented deterioration in adolescent disease care and simultaneously improved adolescent and parent quality of life that included indicators of more effective communication and reduced adherence barriers-without a concomitant increase in diabetes-related or general family conflict. However, contrary to expectation, the Education group was more efficacious than the Coping group in improvement of disease adherence and glycemic control over a 3-year follow-up.Low-intensity office-based quarterly treatment can maintain or improve disease care adherence in early adolescence when provided to adolescent/parent dyads. Better outcomes are achieved when treatment goals and techniques match the needs of the targeted population.

SUBMITTER: Holmes CS

PROVIDER: S-EPMC4030089 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Randomized clinical trial of clinic-integrated, low-intensity treatment to prevent deterioration of disease care in adolescents with type 1 diabetes.

Holmes Clarissa S CS Chen Rusan R Mackey Eleanor E Grey Margaret M Streisand Randi R

Diabetes care 20140312 6

<h4>Objective</h4>To evaluate the efficacy of two office-based treatments designed to prevent deterioration in glycemic control in young adolescents with type 1 diabetes in a randomized clinical trial. An individualized, more intensive family teamwork Coping skills program was compared with a diabetes Education treatment.<h4>Research design and methods</h4>A baseline assessment was followed by four brief treatment sessions and immediate posttesting over the course of 1.5 years. Families of 226 e ...[more]

PMID: 24623027

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Project description:ImportanceWomen with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes.ObjectiveTo investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia.Design, setting, and participantsThis randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled from November 2017 to January 2020, and follow-up ended in January 2021. Data were analyzed from April to July 2021.InterventionsA 12-month lifestyle intervention focused on diet and physical activity involving group and individual sessions, as well as remote engagement, adapted to local context and resources. This was compared with usual care.Main outcomes and measuresThe primary outcome was worsening category of glycemia based on OGTT using American Diabetes Association criteria: (1) normal glucose tolerance to prediabetes (ie, impaired fasting glucose or impaired glucose tolerance) or type 2 diabetes or (2) prediabetes to type 2 diabetes. The primary analysis consisted of a survival analysis of time to change in glycemic status at or prior to the final patient visit, which occurred at varying times after 12 months for each patient. Secondary outcomes included new-onset type 2 diabetes and change in body weight.ResultsA total of 1823 women (baseline mean [SD] age, 30.9 [4.9] years and mean [SD] body mass index, 26.6 [4.6]) underwent OGTT at a median (IQR) 6.5 (4.8-8.2) months postpartum. After excluding 160 women (8.8%) with type 2 diabetes, 2 women (0.1%) who met other exclusion criteria, and 49 women (2.7%) who did not consent or were uncontactable, 1612 women were randomized. Subsequently, 11 randomized participants were identified as ineligible and excluded from the primary analysis, leaving 1601 women randomized (800 women randomized to the intervention group and 801 women randomized to usual care). These included 600 women (37.5%) with prediabetes and 1001 women (62.5%) with normoglycemia. Among participants randomized to the intervention, 644 women (80.5%) received all program content, although COVID-19 lockdowns impacted the delivery model (ie, among 644 participants who engaged in all group sessions, 476 women [73.9%] received some or all content through individual engagement, and 315 women [48.9%] received some or all content remotely). After a median (IQR) 14.1 (11.4-20.1) months of follow-up, 1308 participants (81.2%) had primary outcome data. The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76-1.12]; P = .42) or improve any secondary outcome.Conclusions and relevanceThis study found that a large proportion of women in South Asian urban settings developed dysglycemia soon after a GDM-affected pregnancy and that a lifestyle intervention, modified owing to the COVID-19 pandemic, did not prevent subsequent glycemic deterioration. These findings suggest that alternate or additional approaches are needed, especially among high-risk individuals.Trial registrationClinical Trials Registry of India Identifier: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry Identifier: SLCTR/2017/001; and ClinicalTrials.gov Identifier: NCT03305939.

Project description:BackgroundHealth risk behaviors are the most common sources of morbidity among adolescents. Adolescent health guidelines (Guidelines for Preventive Services by the AMA and Bright Futures by the Maternal Child Health Bureau) recommend screening and counseling, but the implementation is inconsistent.ObjectiveThis study aims to test the efficacy of electronic risk behavior screening with integrated patient-facing feedback on the delivery of adolescent-reported clinician counseling and risk behaviors over time.MethodsThis was a randomized controlled trial comparing an electronic tool to usual care in five pediatric clinics in the Pacific Northwest. A total of 300 participants aged 13-18 years who attended a well-care visit between September 30, 2016, and January 12, 2018, were included. Adolescents were randomized after consent by employing a 1:1 balanced age, sex, and clinic stratified schema with 150 adolescents in the intervention group and 150 in the control group. Intervention adolescents received electronic screening with integrated feedback, and the clinicians received a summary report of the results. Control adolescents received usual care. Outcomes, assessed via online survey methods, included adolescent-reported receipt of counseling during the visit (measured a day after the visit) and health risk behavior change (measured at 3 and 6 months after the visit).ResultsOf the original 300 participants, 94% (n=282), 94.3% (n=283), and 94.6% (n=284) completed follow-up surveys at 1 day, 3 months, and 6 months, respectively, with similar levels of attrition across study arms. The mean risk behavior score at baseline was 2.86 (SD 2.33) for intervention adolescents and 3.10 (SD 2.52) for control adolescents (score potential range 0-21). After adjusting for age, gender, and random effect of the clinic, intervention adolescents were 36% more likely to report having received counseling for endorsed risk behaviors than control adolescents (adjusted rate ratio 1.36, 95% CI 1.04 to 1.78) 1 day after the well-care visit. Both the intervention and control groups reported decreased risk behaviors at the 3- and 6-month follow-up assessments, with no significant group differences in risk behavior scores at either time point (3-month group difference: β=-.15, 95% CI -0.57 to -0.01, P=.05; 6-month group difference: β=-.12, 95% CI -0.29 to 0.52, P=.57).ConclusionsAlthough electronic health screening with integrated feedback improves the delivery of counseling by clinicians, the impact on risk behaviors is modest and, in this study, not significantly different from usual care. More research is needed to identify effective strategies to reduce risk in the context of well-care.Trial registrationClinicalTrials.gov NCT02882919; https://clinicaltrials.gov/ct2/show/NCT02882919.

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Randomized clinical trial of clinic-integrated, low-intensity treatment to prevent deterioration of disease care in adolescents with type 1 diabetes.

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Randomized clinical trial of clinic-integrated, low-intensity treatment to prevent deterioration of disease care in adolescents with type 1 diabetes.

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