Randomized Clinical Trial
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Dec 25, 2015; 6(18): 1355-1362
Published online Dec 25, 2015. doi: 10.4239/wjd.v6.i18.1355
Buddy Study: Partners for better health in adolescents with type 2 diabetes
Allison C Sylvetsky, Radha Nandagopal, Tammy T Nguyen, Marisa R Abegg, Mahathi Nagarur, Paul Kaplowitz, Kristina I Rother
Allison C Sylvetsky, Radha Nandagopal, Tammy T Nguyen, Marisa R Abegg, Mahathi Nagarur, Kristina I Rother, Section on Pediatric Diabetes and Metabolism, NIDDK, National Institutes of Health, Bethesda, MD 20892, United States
Allison C Sylvetsky, Department of Exercise and Nutrition Sciences, the George Washington University, Washington, DC 20037, United States
Radha Nandagopal, Paul Kaplowitz, Division of Endocrinology, Children’s National Medical Center, Washington, DC 20310, United States
Author contributions: Nandagopal R, Kaplowitz P and Rother KI designed this research; Nandagopal R, Nguyen TT and Abegg MR collected the data; Sylvetsky AC, Nagarur M and Rother KI analyzed and interpreted the data; Sylvetsky AC wrote the first draft of the article and all of the authors intellectually contributed to drafting, revising, and writing of the final manuscript; all authors approve of the submission of this manuscript.
Supported by The Intramural Research Program of the National Institutes of Health; the National Institute of Diabetes, Digestive; Kidney Diseases in collaboration with the Division of Endocrinology; and Diabetes at the Children’s National Medical Center (Washington, DC). In addition, funding support was provided by the Endocrine Fellows Foundation Marilyn Fishman Grant for Diabetes Research.
Institutional review board statement: The study protocol, consents and all study procedures were approved by the Institutional Review Boards at the Children’s National Medical Center and at the NIH Clinical Center.
Clinical trial registration statement: This study is registered at ClinicalTrials.gov. The registration identification number is NCT01007266.
Informed consent statement: Informed written consent and assent (in individuals < 18 years of age) were obtained prior to enrollment.
Conflict-of-interest statement: None of the authors have any conflicts of interest to report.
Data sharing statement: Consent for data sharing was not obtained but the presented data are coded and de-identified and the risk of identification is therefore low. No additional data is available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Kristina I Rother, MD, MHSc, Section on Pediatric Diabetes and Metabolism, NIDDK, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 8C432A, Bethesda, MD 20892, United States. kr58q@nih.gov
Telephone: +1-301-4354639 Fax: +1-301-4808277
Received: April 29, 2015
Peer-review started: April 30, 2015
First decision: July 10, 2015
Revised: July 24, 2015
Accepted: September 1, 2015
Article in press: September 2, 2015
Published online: December 25, 2015
Processing time: 235 Days and 10.3 Hours
Abstract

AIM: To investigate whether assigning young, healthy and motivated lay volunteer partners (“buddies”) to adolescents with type 2 diabetes improves hemoglobin A1c (HbA1c).

METHODS: Adolescents with type 2 diabetes were randomized to partnering with a “buddy” or to conventional treatment. During the initial screening visit, which coincided with a routine outpatient diabetes clinic visit, patients with type 2 diabetes underwent a physical examination, detailed medical history, laboratory measurement of HbA1c, and completed two questionnaires (Pediatric Quality of Life Inventory and Children’s Depression Inventory) to assess their overall quality of life and the presence of depressive symptoms. Patients were then randomized to the intervention (the buddy system) or conventional treatment (standard care). All patients were scheduled to return for follow-up at 3- and 6-mo after their initial visit. HbA1c was determined at all visits (i.e., at screening and at the 3- and 6-mo follow-up visits) and quality of life and depressive symptoms were evaluated at the screening visit and were reassessed at the 6-mo visit.

RESULTS: Ten adolescents, recruited from a pool of approximately 200 adolescents, enrolled over a two-year time period, leading to premature termination of the study. In contrast, we easily recruited motivated lay volunteers. We found no change in HbA1c from the initial to the 6-mo visit in either group, yet our small sample size limited systematic assessment of this outcome. Participants repeatedly missed clinic appointments, failed to conduct self-glucose-monitoring and rarely brought their glucometers to clinic visits. Total quality of life scores (72.6 ± 6.06) at screening were similar to previously reported scores in adolescents with type 2 diabetes (75.7 ± 15.0) and lower than scores reported in normal-weight (81.2 ± 0.9), overweight (83.5 ± 1.8), and obese youths without diabetes (78.5 ± 1.8) or in adolescents with type 1 diabetes (80.5 ± 13.1). Among adolescents who returned for their 6-mo visit, there were no differences in total quality of life scores (70.2 ± 9.18) between screening and follow-up.

CONCLUSION: Our approach, effective in adults with type 2 diabetes, was unsuccessful among adolescents and emphasizes the need for innovative strategies for diabetes treatment in adolescent patients.

Keywords: Diabetes mellitus type 2; Quality of life; Adolescent; Hemoglobin A1c; Social support

Core tip: Our manuscript details results and challenges during a simple psychosocial intervention trial where young, healthy and motivated lay volunteer partners (“buddies”) were assigned to adolescents with type 2 diabetes. We experienced difficulty in the recruitment and retention of adolescent patients, which ultimately led to premature study termination. Despite our negative findings, our manuscript calls attention to the fact that psychosocial approaches shown to be effective in adults with type 2 diabetes may not translate in adolescent patients and conveys a unique and important message to other investigators who may wish to attempt similar interventions among adolescents with type 2 diabetes.