THR1VE! Positive psychology intervention to treat diabetes distress in teens with type 1 diabetes: Rationale and trial design

Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control. Building on effective positive psychology interventions to improve adherence in adults, as well as our pilot work to adapt these interventions for adolescents, we developed a positive psychology intervention for adolescents with T1D. The goal of THR1VE! is to reduce diabetes distress in adolescents with T1D and improve their diabetes outcomes. This multi-site randomized controlled trial compares a Diabetes Education + text-message-based Positive Affect intervention, to a Diabetes Education control condition. In the ongoing trial, we are evaluating the effects of the intervention on adolescents' diabetes distress, self-management, and glycemic control. This paper describes the rationale, trial design, and methodology of the THR1VE! Study.     

A comparison of two internet programs for adolescents with type 1 diabetes: design and methods

Implementing psycho-educational programs for youth with type 1 diabetes in clinical care and reaching diverse youth with type 1 diabetes is challenging due to youth, provider, and organizational barriers. This study was designed to compare the effectiveness of an internet coping skills training program with a control condition of internet diabetes education. Each program consists of 5 weekly interactive lessons; the coping skills training program also provides the ability for youth to interact with each other as well as a health coach. Approximately 300 youths with type 1 diabetes will be recruited to participate in this multi-site clinical trial. The primary outcomes are metabolic control, quality of life, and family conflict. Secondary outcomes include stress, coping, self-efficacy, and social competence. Usage, satisfaction, and cost will also be evaluated. In addition, mediators and moderators to intervention effects will be explored. An internet based psycho-educational program for youth with type 1 diabetes may be a promising approach that can be easily be integrated into clinical care.     

The coping styles of adolescents with type 1 diabetes are associated with degree of metabolic control

OBJECTIVE: To systematically study the various coping styles in a population-based sample of adolescents with type 1 diabetes, exploring the association of different coping styles with metabolic control and adolescent self-reported diabetes-related quality of life. RESEARCH DESIGN AND METHODS: Of a total population of 116 adolescents with type 1 diabetes (age 13-18 years), 103 (89%) participated in the study, completing a questionnaire to obtain information on coping styles and perception of diabetes-specific quality of life. The mean age (+/-SD) was 14.9 +/- 1.6 years, diabetes duration 7.1 +/- 3.8 years, HbA(1c) 9.4 +/- 1.6%, and male-to-female ratio 52:51. RESULTS: There was a significant correlation between higher HbA(1c) values and higher degree of mental (r = 0.25, P < 0.05) and behavioral (r = 0.33, P < 0.01) disengagement and aggressive coping (r = 0.33, P < 0.01). Stepwise multiple regression analyses indicated that greater use of aggressive coping (P < 0.05) and behavioral disengagement (P < 0.05) were significantly related to increase in HbA(1c). Greater use of active coping (P < 0.05) was significantly related to a decrease in HbA(1c). Partial correlation analysis showed that lower scores on diabetes-specific quality of life were significantly related to greater use of emotion-focused coping (r = -0.22 to -0.49). Stepwise multiple regression analyses showed that greater use of mental disengagement was significantly related to lower degree of perceived diabetes-related impact. CONCLUSIONS: Poor metabolic control and lower degree of diabetes-related quality of life are associated with greater use of emotion-focused coping in adolescents with type 1 diabetes.     

Weight management for adolescents with intellectual and developmental disabilities: Rationale and design for an 18 month randomized trial

Adolescents with intellectual and developmental disabilities (IDD) are an underserved group in need of weight management. However, information regarding effective weight management for this group is limited, and is based primarily on results from small, non-powered, non-randomized trials that were not conducted in accordance with current weight management guidelines. Additionally, the comparative effectiveness of emerging dietary approaches, such as portion-controlled meals (PCMs) or program delivery strategies such as video chat using tablet computers have not been evaluated. Therefore, we will conduct an 18 month trial to compare weight loss (6 months) and maintenance (7–18 months) in 123 overweight/obese adolescents with mild to moderate IDD, and a parent, randomized to a weight management intervention delivered remotely using FaceTime™ on an iPad using either a conventional meal plan diet (RD/CD) or a Stop Light diet enhanced with PCMs (RD/eSLD), or conventional diet delivered during face-to-face home visits (FTF/CD). This design will provide an adequately powered comparison of both diet (CD vs. eSLD) and delivery strategy (FTF vs. RD). Exploratory analyses will examine the influence of behavioral session attendance, compliance with recommendations for diet (energy intake), physical activity (min/day), self-monitoring of diet and physical activity, medications, and parental variables including diet quality, physical activity, baseline weight, weight change, and beliefs and attitudes regarding diet and physical activity on both weight loss and maintenance. We will also complete a cost and contingent valuation analysis to compare costs between RD and FTF delivery.     

A coping intervention for mothers of children diagnosed with cancer: Connecting theory and research

There are approximately 13,500 children diagnosed with cancer every year in the United States (Centers for Disease Control and Prevention, 2014). Mothers of children newly diagnosed with cancer often exhibit symptoms of stress, depression, and anxiety (Dunn et al., 2012; Fedele, Mullins, Wolfe-Christensen, & Carpentier, 2011; Felicity et al., 2009). This article describes the theoretical framework of a study which, coupled with previous research, was used to design a coping intervention to facilitate coping in mothers' of children newly diagnosed with cancer. The intervention is entitled Creating Opportunities for Parent Empowerment- Parents of Children with Cancer (COPE-PCC).     

Self-care of young adolescents with type 1 diabetes

The purpose of this study was to describe the universal and health deviation self-care of adolescents with Type 1 diabetes and the associations of basic conditioning factors with universal and health deviation self-care. Subjects for this study were 152 adolescents aged between 11 and 15 years with a diagnosis of Type 1 diabetes. Data were collected in the home setting of each adolescent and his or her family. The mean universal self-care scores ranged from 66.62% to 90%. The overall mean for this sample was 75.37, indicating that these adolescents took care of their self-care needs 75% of the time. Health deviation self-care was a mean of 27.26, indicating more positive self-care behaviors and treatment adherence. Health deviation and universal self-care were significantly and positively related (r = .36, p < .001). Ethnicity and adolescent sex were statistically significant in predicting universal self-care. Adolescent age was statistically significant in predicting health deviation self-care. Health deviation self-care decreases with age, suggesting that early adolescence or late school age is an appropriate time for interventions to strengthen self-care behaviors. Furthermore, the interrelationship of the two types of self-care supports the potential for a synergistic effect of intervention.     

Jump starting shared medical appointments for diabetes with weight management: Rationale and design of a randomized controlled trial

BackgroundRates of glycemic control remain suboptimal nationwide. Medication intensification for diabetes can have undesirable side effects (weight gain, hypoglycemia), which offset the benefits of glycemic control. A Shared Medical Appointment (SMA) intervention for diabetes that emphasizes weight management could improve glycemic outcomes and reduce weight while simultaneously lowering diabetes medication needs, resulting in less hypoglycemia and better quality of life. We describe the rationale and design for a study evaluating a novel SMA intervention for diabetes that primarily emphasizes low-carbohydrate diet-focused weight management.MethodsJump Starting Shared Medical Appointments for Diabetes with Weight Management (Jump Start) is a randomized, controlled trial that is allocating overweight Veterans (body mass index ≥ 27 kg/m²) with type 2 diabetes into two arms: 1) a traditional SMA group focusing on medication management and self-management counseling; or 2) an SMA group that combines low-carbohydrate diet-focused weight management (WM/SMA) with medication management. Hemoglobin A1c reduction at 48 weeks is the primary outcome. Secondary outcomes include hypoglycemic events, diabetes medication use, weight, medication adherence, diabetes-related quality of life, and cost-effectiveness. We hypothesize that WM/SMA will be non-inferior to standard SMA for glycemic control, and will reduce hypoglycemia, diabetes medication use, and weight relative to standard SMA, while also improving quality of life and costs.ConclusionsJump Start targets two common problems that are closely related but infrequently managed together: diabetes and obesity. By focusing on diet and weight loss as the primary means to control diabetes, this intervention may improve several meaningful patient-centered outcomes related to diabetes.     

Pedometers and Text Messaging to Increase Physical Activity: Randomized controlled trial of adolescents with type 1 diabetes

OBJECTIVE

To assess whether pedometers and text messaging increase physical activity in adolescents with type 1 diabetes.

RESEARCH DESIGN AND METHODS

A 12-week randomized controlled trial was conducted. A total of 78 subjects participated in the trial (mean ± SD age 14.4 ± 2.37 years, 36 [47%] male). Intervention participants wore an open pedometer and received regular motivational text messages. Control participants received usual care. Primary outcomes were daily step count (4-day closed pedometer) and physical activity questionnaire.

RESULTS

Baseline median step count was 11,063 steps/day (range 1,541–20,158). At 12 weeks, mean daily step count reduced by 840 (95% CI −1,947 to 266) in the control group and by 22 (−1,407 to 1,364) in the intervention group (P = 0.4). Mean self-reported moderate or vigorous physical activity increased by 38.5 min/week in the control group and by 48.4 in the intervention group (P = 0.9).

CONCLUSIONS

A 12-week intervention using pedometers and text messaging as motivational tools in adolescents with type 1 diabetes did not increase physical activity.Adolescents with type 1 diabetes require ongoing care and support to manage diabetes (1,2). Physical activity is an important contributor to glycemic control (3), has multiple effects on blood glucose, insulin sensitivity, weight management, mental health, social development (4,5), and subsequent cardiovascular disease risk (6), but may not be seen as a priority by adolescents. Physical activity often declines during adolescence because physical education at school is no longer compulsory; adolescents may stop playing weekend sports, receive a driver''s license, participate in after-school programs, or receive weekend jobs (7,8).     

Prevalence of diabetes complications in adolescents with type 2 compared with type 1 diabetes

OBJECTIVE: To compare the prevalence of diabetes complications and their risk factors in youth with type 1 versus type 2 diabetes. RESEARCH DESIGN AND METHODS: We performed a comparative clinic-based study of 1,433 patients with type 1 diabetes and 68 patients with type 2 diabetes aged <18 years from New South Wales, Australia. Retinopathy was assessed by seven-field stereoscopic retinal photography; albumin excretion rate from three consecutive, timed, overnight urine collections; peripheral neuropathy by thermal and vibration threshold; and autonomic neuropathy by pupillometry. HbA(1c) (A1C) and lipids were measured in all patients and C-peptide in patients with type 2 diabetes. RESULTS: In patients with type 1 versus type 2 diabetes, median (interquartile range) age was 15.7 years (13.9-17.0) and 15.3 years (13.6-16.4), respectively (P = 0.2), whereas median diabetes duration was 6.8 years (4.7-9.6) and 1.3 years (0.6-3.1), respectively (P < 0.0001). Retinopathy was significantly more common in patients with type 1 diabetes (20 vs. 4%, P = 0.04), while microalbuminuria and hypertension were significantly less common (6 and 16% in type 1 diabetes vs. 28 and 36% in type 2 diabetes). Rates of peripheral and autonomic neuropathy were similar (27 and 61% in type 1 diabetes vs. 21 and 57% in type 2 diabetes). In multivariate analyses, microalbuminuria was significantly associated with older age (odds ratio 1.3 [95% CI 1.2-1.5], P < 0.001) and systolic hypertension (3.63 [2.0-6.3], P < 0.001) in type 1 diabetes, while only higher A1C (1.7 [1.3-2.9], P = 0.002) was significant in patients with type 2 diabetes. CONCLUSIONS: Youth with type 2 diabetes have significantly higher rates of microalbuminuria and hypertension than their peers with type 1 diabetes, despite shorter diabetes duration and lower A1C. The results of this study support recommendations for early complications screening and aggressive targeting of glycemic control in patients with type 2 diabetes.     

Immune intervention for type 1 diabetes mellitus

The major form of type 1 diabetes (T1D) is characterised by immune-mediated pancreatic islet β-cell destruction, and has also been called type 1A diabetes to distinguish it from idiopathic forms of islet β-cell loss. Since the first demonstration of islet cell antibodies in 1974, the concept has been that this form of diabetes is autoimmune in nature. The commonly accepted concept is that antibodies (representing the humoral arm of the immune system) do not mediate the β-cell destruction but rather serve as markers of that destruction, while the cellular arm of the immune system, specifically T-lymphocytes, mediate the β-cell destruction. Yet, the T-lymphocytes do not act alone. They receive help in initiating the response from antigen-presenting cells such as dendritic cells and macrophages, and appear to receive help also from B-lymphocytes. In addition, the initial immune response engenders secondary and tertiary responses - involving the whole immunological army - which collectively result in impairment of β-cell function, progressive destruction of β-cells, and consequent development of type 1A diabetes. The process is insidious and may evolve over many years, with the overt expression of clinical symptoms becoming apparent only when most β-cells have been destroyed. Yet, the process clearly evolves at different speeds - much more rapidly in young children, much more slowly in older individuals. And, although it has been thought that ultimately there is complete β-cell destruction, several studies have now demonstrated some degree of persistent β-cell function or existence (at autopsy) in long-standing T1D. A major focus of investigation in T1D is the preservation of β-cell function (and, it is hoped, of β-cells themselves), in the expectation that continuing endogenous insulin secretion will contribute towards better glycaemic control, reduce episodes of severe hypoglycaemia, and slow the development of complications such as retinopathy and nephropathy. Thus, there have been many studies designed to interdict the T1D disease process, mostly by altering the immune system, both during the stage of evolution of the disease and at the time of disease onset. This chapter of the Yearbook of Advanced Technology and Treatments in Diabetes reviews the key papers that have appeared in this field between July 2009 and June 2010. Articles selected were confined to studies in human beings. All immune intervention studies reported in this time frame were included. In addition, the author selected other relevant articles dealing with mechanisms, markers, triggers, and pathology of human type 1 diabetes.     

Failure to maintain the benefits of home-based intervention in adolescents with poorly controlled type 1 diabetes

OBJECTIVE: To determine whether a 6-month home-based intervention program in adolescents with poorly controlled diabetes improves metabolic control and whether benefits are maintained after the intervention. RESEARCH DESIGN AND METHODS: Adolescents with a mean HbA1c of > 9.0% over the preceding 12 months received either routine care in a diabetes clinic and an ambulatory intervention for 6 months (n = 37) or routine care only (n = 32). A diabetes educator provided monthly home visits and weekly phone contact to educate and support the adolescents in setting goals for insulin adjustment, blood glucose monitoring, and target blood glucose range. There was no systematic change in the frequency of insulin injections. After the intervention, there was a 12-month follow-up when the intervention and control groups both received only routine care. Outcome measures were HbA1c and Diabetes Knowledge Assessment (DKN). RESULTS: During the intervention, mean HbA1c fell (baseline: 11.1 +/- 1.3%, 6 months: 9.7 +/- 1.6%; P = 0.0001) and mean knowledge scores increased (P = 0.0001) in the intervention group but not in control subjects. However, this improvement in HbA1c and increase in knowledge was not maintained in the intervention group at 12- and 18-month follow-up assessments. Parents' knowledge scores also improved significantly from baseline levels in the intervention group at 6 and 12 months (P = 0.001, P = 0.005, respectively). CONCLUSIONS: An ambulatory program improves metabolic control and knowledge in adolescents with poorly controlled type 1 diabetes; however, it is effective only while the intervention is maintained.     

Assessing regimen adherence of adolescents with type 1 diabetes

OBJECTIVE: The purpose of this study is to evaluate two updated measures of diabetes regimen adherence. The Diabetes Self-Management Profile (DSMP) is a widely used, structured interview. Limitations include a substantial interviewer and respondent time burden and the need for well-trained interviewers to use appropriate prompts and score the open-ended responses. The Diabetes Behavior Rating Scale (DBRS) is a self-administered, fixed-choice survey. RESEARCH DESIGN AND METHODS: Both measures were administered to 146 youth with type 1 diabetes (aged 11-18 years) and their parents. Items were added to the DBRS to allow for both flexible and conventional regimens, and the DSMP was modified to use standardized wording across items, accommodate flexible regimens, and permit administration by nonmedical interviewers. RESULTS: Both measures had good evidence of internal consistency (for the DSMP: parent 0.75 and youth 0.70; for the DBRS: parent 0.84 and youth 0.84). Scores on the DSMP and the DBRS were significantly related (r = 0.72 for parents and 0.74 for youth). There was moderate agreement between parent and youth (DSMP, r = 0.51; DBRS, r = 0.48). The measures were correlated with HbA1c for both parent (DSMP, r = -0.35; DBRS, r = -0.35) and youth (DSMP, r = -0.36; DBRS, r = -0.34) reports. CONCLUSIONS: Both measures exhibit good psychometric properties and good criterion validity but varied in terms of respondent and interviewer burden, issues that should be considered in selecting assessment procedures.     

Metformin as an adjunct therapy in adolescents with type 1 diabetes and insulin resistance: a randomized controlled trial

OBJECTIVE: To evaluate whether, in adolescents with type 1 diabetes, the addition of metformin to insulin and standard diabetes management results in 1) higher insulin sensitivity and 2) lower HbA1c, fasting glucose, insulin dosage (units per kilogram per day) and BMI. RESEARCH DESIGN AND METHODS: This was a randomized, placebo-controlled 3-month trial of metformin therapy in 27 adolescents with type 1 diabetes, high insulin dosage (>1 unit. kg(-1). day(-1)), and HbA1c >8%, with measurements of insulin sensitivity (by frequently sampled intravenous glucose tolerance test [FSIGT]), HbA1c, insulin dosage, and BMI at the onset and end of treatment. RESULTS: At t = 0, HbA1c was 9.2 +/- 0.9%, insulin dosage was 1.2 +/- 0.2 units. kg(-1). day(-1), fasting glucose was 10.6 +/- 2.4 mmol/l, and BMI was 24.2 +/- 3.9 kg/m2 (means +/- SD), with no difference between the metformin and placebo groups. At the end of the study, HbA1c was 0.6% lower in the metformin group than in the placebo group (P < 0.05). This was achieved at lower daily insulin dosages (metformin group -0.14 +/- 0.1 vs. placebo group 0.02 +/- 0.2 units. kg(-1). day(-1); P < 0.05), with no significant change in BMI. Fasting glucose levels improved significantly in the metformin group (P < 0.05). Change in insulin sensitivity, measured by FSIGT, was not significantly different between the two groups at study end. Mild hypoglycemia occurred more frequently in the metformin-treated than in the placebo subjects (1.75 +/- 0.8 vs. 0.9 +/- 0.4 events. patient(-1). week(-1); P = 0.03). There were no differences in frequency of severe hypoglycemic episodes or gastrointestinal complaints between the two groups. CONCLUSIONS: Metformin treatment lowered HbA1c and decreased insulin dosage with no weight gain in teens with type 1 diabetes in poor metabolic control. Changes in insulin sensitivity were not documented in this study using the FSIGT. Long-term studies will determine whether these improvements are sustained and whether certain subgroups accrue greater benefit from this therapy.     

Supporting adolescents with type 1 diabetes mellitus: A qualitative study

Without sufficient support, type 1 diabetes mellitus often disturbs patients' normal lives. This study describes and explores the support that Iranian adolescents with type 1 diabetes mellitus experienced. Semistructured interviews were conducted with ten adolescents, seven family members, one dietitian, one nurse, and one school nurse. Participants were chosen using purposive sampling from two teaching hospitals and one high school in two urban areas of Iran. Using standard procedures for content analysis, three main themes were identified: maintaining a normal life; receiving tangible, informational, and emotional support from the family and society; and advancement of life toward normalization. The cornerstone of maintaining a normal life for adolescents with type 1 diabetes mellitus is to adopt an active role in taking care of themselves within their systems of support.