Partners for Better Health in Adolescent Type 2 Diabetes: The Buddy Study
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 12 - 20 |
| Updated: | 3/27/2019 |
| Start Date: | October 9, 2009 |
| End Date: | January 24, 2013 |
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.
- 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.
Background
Type 2 diabetes mellitus (T2DM) is becoming increasingly prevalent among youth, particularly
in minority populations. Few pharmacologic agents are approved for the treatment of T2DM in
adolescents, and behavioral and lifestyle factors may contribute to adolescents difficulty
adhering to treatment regimens. A minimally-invasive buddy-intervention (to help improve
diabetes control and to foster improvement in quality of life) has not been systematically
evaluated in a population of pediatric patients with T2DM.
Objectives
1. To evaluate the effect of a minimally invasive intervention the buddy on hemoglobin A1c
(HbA1c) levels in adolescents with T2DM.
2. 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.
Methods
Patients will be randomized to conventional treatment versus interventional group (buddy
arm), and will be followed for 6 months. During this period, all patients should undergo two
visits including laboratory testing (HbA1c) approximately 3 months apart. Those in the buddy
arm will have weekly phone or online contact and once-monthly home visits from the buddy (a
volunteer patient partner), with the use of systematic questionnaires and a secure database
for data collection and maintenance.
Type 2 diabetes mellitus (T2DM) is becoming increasingly prevalent among youth, particularly
in minority populations. Few pharmacologic agents are approved for the treatment of T2DM in
adolescents, and behavioral and lifestyle factors may contribute to adolescents difficulty
adhering to treatment regimens. A minimally-invasive buddy-intervention (to help improve
diabetes control and to foster improvement in quality of life) has not been systematically
evaluated in a population of pediatric patients with T2DM.
Objectives
1. To evaluate the effect of a minimally invasive intervention the buddy on hemoglobin A1c
(HbA1c) levels in adolescents with T2DM.
2. 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.
Methods
Patients will be randomized to conventional treatment versus interventional group (buddy
arm), and will be followed for 6 months. During this period, all patients should undergo two
visits including laboratory testing (HbA1c) approximately 3 months apart. Those in the buddy
arm will have weekly phone or online contact and once-monthly home visits from the buddy (a
volunteer patient partner), with the use of systematic questionnaires and a secure database
for data collection and maintenance.
- INCLUSION CRITERIA:
Any patient with type 2 diabetes mellitus as documented by his or her primary physician
1. Age 12-20 years at enrollment
2. Most recent HbA1c greater than or equal to 7%
EXCLUSION CRITERIA:
1. Significant comorbidity that, in the opinion of the investigators, may limit adequate
study participation
2. Significant psychiatric or cognitive disorder, or communication difficulty that will,
in the opinion of the investigators, limit the subject's ability to interact with the
patient assistant or may present a danger to the patient assistant; patients with
current suicidal or homicidal ideation, history of arrest for violent behavior, or
history of school suspension/expulsion for violent behavior will be excluded.
3. Pregnancy or intention to become pregnant within 6 months
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