Randomized efficacy trial of early preconception counseling for diabetic teens (READY-girls)

Abstract

Objective: To develop and assess the feasibility of an early preconception counseling program for adolescents called READY-Girls (Reproductive-health Education and Awareness of Diabetes in Youth for Girls).

Research design and methods: A total of 53 adolescent females with type 1 diabetes between 16 and 19.9 years of age were randomized into groups receiving a CD-ROM, a book, or standard care (control) and given one comprehensive session. Outcomes were assessed at baseline, immediately after, and at 3 months.

Results: Teens who received the CD and those who received the book demonstrated significant (P < or = 0.05) sustained improvement (over 3 months) in knowledge, perceived benefits of both receiving preconception counseling and using effective family planning, and perceived more support with reproductive health issues.

Conclusions: Clinical feasibility of the program was demonstrated. Both the CD and the book appeared to be efficacious formats for the short term. Future studies should examine repeated boosters of a CD and a book, which are not meant to replace but rather to reinforce and supplement health professional education.

Figure 1—

Group response profiles for outcome variables expressed as percent change from baseline values to follow-up post-test values. A: Total knowledge (diabetes pregnancy, contraception, sexuality, and family planning), a summation of 25 dichotomous items (correct = 1, incorrect = 0, % correct). B: Perceived benefits of seeking PC and using family planning, a summation of five Likert-type items (possible range = 5–25). C: Perceived barriers to seeking PC and using family planning, a summation score of five Likert-type items (possible range = 5–25). D: Perceived availability of social support (emotional, informational, and instrumental) with PC and family planning, a summation of eight Likert-type items (possible range = 8–40). E: Intention to seek PC and use effective family planning, a summation of three items (1 = unlikely through 7 = likely; possible range = 3–21). F: A1C (metabolic control) measured by the home Accu-Base HbA1c Sample Collection Kit. Blood fingerstick assays were analyzed in Vanderbilt Pathology Lab Services, Vanderbilt University Medical Center, using a high-performance liquid chromatography analyzer (ion-exchange method) (Bio-Rad Diamat HPLC; Bio-Rad, Hercules, CA). The reference range for the Diamat HPLC was 4.2–5.8%. Baseline = pretest; post-test 1 = immediate postintervention; and post-test 2 = 3-month follow-up. Three-month analyses were conducted on completed longitudinal data from 47 subjects (16 [34%] CD, 16 [34%] book, and 15 [32%] control) controlling for sexual activity and age as covariates.