CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Assignment of a Lay Patient Partnerbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01007266
NCT01007266Phase 2Completed

Partners for Better Health in Adolescent Type 2 Diabetes: The Buddy Study

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Nov 4, 2009·Updated Dec 17, 2019

In Brief

A Phase 2 clinical trial evaluating Assignment of a Lay Patient Partner for Obesity and 3 related conditions. Completed, enrolled 10 participants across 2 sites.

Detailed Summary

Background: * Type 2 diabetes mellitus (T2DM) is becoming more common among youth, particularly in minority populations. Few drug treatments are approved for T2DM in adolescents, and behavioral and lifestyle factors may contribute to their difficulties in following strict treatment regimens. * It is unknown whether a minimally invasive patient partner ( buddy ) program, which has been developed to help improve diabetes control and quality of life, will be successful in a population of pediatric patients with T2DM. Objectives: * To evaluate the effect of a minimally invasive intervention (being assigned a patient partner, or buddy ) on blood sugar levels in adolescents with T2DM. * To assess changes between groups in body weight, number of home glucose monitor checks, compliance with medications, adherence to visit schedule, and psychological well-being. Eligibility: \- Adolescents and young adults between 12 and 20 years of age who have been diagnosed with type 2 diabetes and whose blood glucose control needs improvement. Design: * Participants will be divided by chance into two groups: in one group, participants will have a buddy and receive standard care; while in the other group, participants will receive standard care alone. * The buddy is not a health care professional and is not authorized to provide any medical advice. * Participants will be followed in the study for a total of 6 months. All study participants will receive standard treatment for T2DM. * All patients will be asked to fill out a screening questionnaire (on paper or online) at the beginning of the study and a quality of life and eating behaviors questionnaire at the beginning and at the end of the study. These forms will include questions on medical history, emotions, well-being, and eating habits. * Participants in both groups will have one diabetes clinic visit at the NIH Clinical Center or at Children s National Medical Center (CNMC) at the beginning of the study and two follow-up visits at the NIH or CNMC approximately 3 months apart. All visits include a physical examination, detailed medical history, and laboratory testing which is part of routine care for diabetes. * Participants assigned to the buddy group will receive phone or online messages from the buddy once a week and will meet with the buddy once a month for less than 1 hour. The purpose of the in-person visit is to get to know each other better outside the usual hospital or clinic environment. The visits should take place at home, but may also take place elsewhere, for example, at schools, cafes, or libraries chosen by both the participant and the buddy. These face-to-face meetings may also take place at NIH or at CNMC if this is more convenient.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2009
Enrollment StartOct 9, 2009
Study CompletionJan 24, 2013
TodayJul 2, 2026
Posted 16.7 years ago

Interventions

Assignment of a Lay Patient Partnerbehavioral