Introduction to the TODAY Study

The TODAY study group brought together investigators in a collaborative effort involving institutions across the country to design and conduct a prospective, randomized trial to evaluate treatment regimens and the clinical course of type 2 diabetes in youth.  In order to be eligible to be in the study, participants had to have type 2 diabetes diagnosed according to American Diabetes Association criteria within the previous 2 years, absence of islet autoantibodies, BMI >= 85^th percentile, age 10-17 years, and a family member willing to participate in the child's treatment.  A total of 699 participants were enrolled from 2004-2009 and followed for 2 to 6 years. 

All participants received the TODAY Standard Diabetes Education (TSDE) program.  Each participant was randomly assigned to one of three treatment arms:

• Metformin alone.
• Metformin plus Rosiglitazone.
• Metformin plus the TODAY Lifestyle Program (TLP), an intensive lifestyle program  incorporating nutrition, physical activity, and behavior modification. 

The primary outcome was time to treatment failure due to loss of glycemic control, defined as hemoglobin A1c >= 8% for 6 months.  Secondary outcomes included measures of beta cell function and insulin resistance, body composition, nutrition, physical activity and aerobic fitness, cardiovascular risk factors, microvascular complications, quality of life, and psychological outcomes.  The influence of individual and family behaviors on treatment response and the relative cost effectiveness of the three treatment arms were also evaluated. 

This national study is likely to provide information fundamental to improving treatments and outcomes for youth with type 2 diabetes.

Click on the ‘Publications' tab to download publications by the TODAY study group, including design and rationale of the TODAY study, development of the TSDE, and development of the TLP.

The rise in rates of type 2 diabetes in children and adolescents is relatively recent.  Initially, healthcare providers and clinicians diagnosing and treating youth-onset type 2 diabetes had to rely on materials designed for youth with type 1 diabetes or adults with type 2 diabetes.  As development of the TODAY study began, the study group recognized that a systematic educational program was needed to assure that children and families had a firm foundation in knowledge and skills specific to type 2 diabetes.  The TSDE was administered to all study participants.  The basic curriculum was in a manual covered during a pre-randomization run-in period.  Throughout follow-up, additional handouts and tip sheets were available as needed. 

The purposes of the TSDE are:

1. to provide the participants and supportive family members with basic knowledge about type 2 diabetes, and
2. to teach basic survival skills and behaviors that are important for successful management of this disease.  

Educational content deals with the physiology of type 2 diabetes, treatment, management, and progressive skill building.  Materials have been combined into interactive, developmentally appropriate, and culturally sensitive workbooks provided to the youth and family members.  In order to participate in TODAY, youth had to speak and read English; many materials are also provided in Spanish in order to involve family members who do not know English.  Materials are designed to be administered by any member of a diabetes care clinical team, not just a certified diabetes educator (CDE).  Education can be provided by telephone, in person, or in groups.

Click on the 'Publications' tab to download the TODAY publication ‘Development of a diabetes education program for youth with type 2 diabetes' (published in Diabetes Educator 2009, volume 35, pages 108-116). 

Other sites providing materials and information about diabetes are:

• The American Diabetes Association
• The National Diabetes Education Program

TODAY Lifestyle Program (TLP)

The TODAY Lifestyle Program (TLP) was designed to be administered in three phases.  A Personal Activity-nutrition Leader (PAL) on the staff of each TODAY clinical center delivered the program to the youth participant and family support person (FSP, the adult caregiver who formed a supportive partnership with the youth during the study).  The PAL was overseen by a supervising psychologist.  

The three phases of the TLP are:  

1.    Lifestyle Change (LC) focuses on achieving weight, physical activity, and behavior change goals.  A set curriculum is presented to ensure that a standard program is delivered.  LC lasts a minimum of 6 months to a maximum of 8 months, during which time 24 lessons are covered in weekly in-person meetings.  

2.    Lifestyle Maintenance (LM) also delivers a set curriculum focusing on strengthening and reinforcing skills and concepts introduced during the LC phase, and preserving the positive changes that were accomplished during this phase.  The LM phase also promotes further dietary and physical activity changes where appropriate.  The LM extends a minimum of 6 months and a maximum of 8 months after the end of the LC phase.  Weekly delivery alternates between in-person visits (total of 12) and phone sessions (also 12).  Participant, FSP, and PAL choose from 20 available educational modules, in addition to being able to continue to use the materials and modules from the LC phase.    

3.    Continued Contact (CC) focuses on helping participants solve problems as they arise in order to avoid a return to unhealthy, preexisting behaviors, and to continue to work towards change where appropriate.  This phase does not have set topics to review.  Instead, a library of topics is available from which to draw relevant information for working with families on specific issues.  Contact during the CC phase is intended to maintain the team approach to diabetes care and management, while transferring more responsibility to the youth as he/she ages.  The phase starts with monthly in-person meetings with the youth and FSP and a phone call in between monthly sessions for about 12 months, followed by in-person visits held in conjunction with regular quarterly clinic visits.  Other forms of contact, such as phone calls, e-mail, texting, etc., may be used to keep connected and informed.  

Click on the 'Publications' tab to download the TODAY publication ‘Design of a family-based lifestyle intervention for youth with type 2 diabetes: the TODAY study' (published in International Journal of Obesity 2010, volume 34, pages 217–226).

In order to participate in TODAY, youth had to speak and read English; many materials are also provided in Spanish in order to involve family members who do not know English.

Institutions

Partnering institutions and collaborators.

Publications

• 2006 Songer et al., Expert Rev Pharmacoeconomics Outcomes Res

• 2007 TODAY Study Group, Pediatric Diabetes

• 2009 Grey et al., Diabetes Educator

• 2010 TODAY Study Group, Internatl J Obesity

• 2010 Klingensmith et al., Diabetes Care

• 2011 Larkin et al., Applied Clinical Trialss

• 2011 Copeland et al., J Clin Endo & Metab

• 2011 TODAY Study Group, Diabetes Care

• 2011 Anderson et al., Diabetes Care