Examining the economic costs related to lifestyle and pharmacological interventions in youth with Type 2 diabetes

Songer, Thomas J.; Glazner, Judith E.; Coombs, Laura P.; Cuttler, Leona; Daniel, Mary; Estrada, Silvia; Klingensmith, Georgeanna J.; Kriska, Andrea M.; Laffel, Lori M.; Zhang, Ping

doi:10.1586/14737167.6.3.315

Cited by 7 publications

(4 citation statements)

References 42 publications

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“…Also, to offset the potential costs of travel to deliver the intervention off-site,63,64 distance telemedicine technologies can be used in the TLP 65. For example, at the time of this writing, the clinical site at Oklahoma had provided nine TLP visits to four families (two Native American, one African American and one Asian American) using web cams (Logitech QuickCam Communicates and Orbit AF, Logitech, Fremont, CA, USA), videophones (Starview 500 TravelStar Pro XL, Starview VideoCom Corporation, Tucson, AZ, USA) or video teleconferencing systems (various Polycom systems, Polycom Corporation, Pleasanton, CA, USA).…”

Section: Implications and Future Directionsmentioning

confidence: 99%

Design of a family-based lifestyle intervention for youth with type 2 diabetes: the TODAY study

Nwosu¹

2009

Int J Obes

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Type 2 diabetes is associated with obesity and is increasing at an alarming rate in youth. Although weight loss through lifestyle change is one of the primary treatment recommendations for adults with type 2 diabetes, the efficacy of this approach has not been tested with youth. This paper provides a summary of the reviews and meta-analyses of pediatric weight-loss interventions that informed the design and implementation of an intensive, family-based lifestyle weight management program for adolescents with type 2 diabetes and their families developed for the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. A total of 1092 youth have been screened, and 704 families have been randomized for inclusion in this 15-center clinical trial sponsored by the National Institutes of Health. The TODAY study is designed to test three approaches (metformin, metformin plus rosiglitazone and metformin plus an intensive lifestyle intervention) to the treatment of a diverse cohort of youth, 10-17 years of age, within 2 years of their diagnosis. The principal goal of the TODAY Lifestyle Program (TLP) is to decrease baseline weight of youth by 7-10% (or the equivalent for children who are growing in height) through changes in eating and physical activity habits, and to sustain these changes through ongoing treatment contact. The TLP is implemented by interventionists called Personal Activity and Nutrition Leaders (PALs) and delivered to youth with type 2 diabetes, and at least one family support person. The TLP provides a model for taking a comprehensive, continuous care approach to the treatment of severe overweight in youth with comorbid medical conditions such as type 2 diabetes.

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Section: Implications and Future Directionsmentioning

confidence: 99%

Design of a family-based lifestyle intervention for youth with type 2 diabetes: the TODAY study

Nwosu¹

2009

Int J Obes

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“…Table 1 also lists measures that were administered, but not hypothesized to be primary outcome, secondary outcome, or potential mediator variables. These additional measures included: Specific Health Care Use (designed specifically for FLEX), FLEX Cost Survey [adapted from 18 ], Food Security Questionnaire 19 , Diabetes Eating Problem Survey 20 , Health Behaviors and Home Environment [adapted from 21–23 ], External Eating 24 , 24-hour Diet & Physical Recall 25–28 , and Hypoglycemia Fear Survey 29–31 . In order to determine cost effectiveness, we will compare the total cost of FLEX to usual diabetes care, and we will estimate cost per unit change in HbA1c and per quality adjusted life year using the Health Utilities Index 32 .…”

Section: Methodsmentioning

confidence: 99%

The Flexible Lifestyle Empowering Change (FLEX) intervention for self-management in adolescents with type 1 diabetes: Trial design and baseline characteristics

Kichler

Seid

Crandell³

et al. 2018

Contemporary Clinical Trials

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The Flexible Lifestyle Empowering Change (FLEX) Intervention Study is a multi-site randomized controlled trial to test the efficacy of an adaptive behavioral intervention to promote self-management for youth with type 1 diabetes mellitus (T1D). This paper details FLEX design, demographic characteristics of the sample, and outcome variables at baseline. Participants were randomized to either an intervention or control arm after their baseline standardized measurement visit. Baseline data for the primary (glycemic levels) and secondary outcome variables (e.g., motivation and problem-solving, health-related quality of life, risk factors associated with T1D complications) as well as the potential mediator variables (e.g., self-management behavior, family conflict and responsibility) suggest that the study sample was representative of the general population of adolescents with T1D and their parents. The FLEX adaptive intervention is an innovative application of a tailored treatment intervention designed to be readily adopted in real-world practice to meet each adolescent's individualized T1D self-management goals.

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“…Purchased food was categorized as either (a) regular expenses made in grocery stores, specialty stores (eg, bakery, delicatessen), or for school lunch or (b) meals eaten at or carried out from restaurants, vending machines, or fast‐food establishments. Further details on these methods and the specific items captured in the assessments are available in a prior publication …”

Section: Methodsmentioning

confidence: 99%

“…A secondary aim of the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial was to investigate the economic resources involved in the treatment and management of T2D in youth and to outline the economic implications of these treatment options for families and caregivers . This report uses data gathered in the first 2 years of TODAY to describe the predominant economic costs and issues related to three treatment options for youth and adolescents with T2D: metformin alone (M), metformin plus rosiglitazone (M + R), and metformin plus a lifestyle and behavior modification program (M + L) .…”

Section: Introductionmentioning

confidence: 99%

Healthcare and associated costs related to type 2 diabetes in youth and adolescence: the TODAY clinical trial experience

et al. 2019

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The economic issues related to medical treatments in youth with type 2 diabetes (T2D) are rarely reported and thus not fully understood. The TODAY clinical trial of youth recently diagnosed with T2D collected healthcare and related cost information from the largest cohort studied to date. Costs related to medical treatments and expenses faced by caregivers were identified over a two-year period from 496 participants. Data were collected by surveys and diaries to document frequency of use of diabetes care (excluding study laboratory tests), non-diabetes care services and treatments, caregiver time, and expenses related to exercise and dietary activities recommended for patients. Economic costs were derived by applying national cost values to the reported utilization frequency data. Annual medical costs in the first year varied by treatment group, averaging $1798 in those assigned to metformin alone (M), $2971 to combination drug therapy with metformin + rosiglitazone (M+R), and $2092 to metformin + an intensive lifestyle and behavior change program (M+L). Differences were primarily due to costs related to combination drug therapy. Adult caregiver support costs were higher for participants in the lifestyle program, which was delivered in weekly sessions in the first six months. Expenses for purchases to enhance diet and exercise change did not vary by treatment assignment. In year 2, medication costs increased in M and M+L due to the initiation of insulin in subjects who failed to maintain glycemic control on the assigned treatment. Data are reported for use by researchers and those providing healthcare to this vulnerable patient population.

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Examining the economic costs related to lifestyle and pharmacological interventions in youth with Type 2 diabetes

Cited by 7 publications

References 42 publications

Design of a family-based lifestyle intervention for youth with type 2 diabetes: the TODAY study

Design of a family-based lifestyle intervention for youth with type 2 diabetes: the TODAY study

The Flexible Lifestyle Empowering Change (FLEX) intervention for self-management in adolescents with type 1 diabetes: Trial design and baseline characteristics

Healthcare and associated costs related to type 2 diabetes in youth and adolescence: the TODAY clinical trial experience

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