Community-based Adolescent Diabetes Prevention Program
2019년 11월 20일 업데이트: Icahn School of Medicine at Mount Sinai
TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention
The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a disproportionate increase among minority youth.
The research proposed in this Career Development Award will use community-based participatory research methodology as well as novel strategies (peer education and mobile health technologies) to design, implement and evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban community with high disease burden.
연구 개요
상세 설명
Approach: The proposed research addresses diabetes risk and prevention among racial/ethnic minority adolescents in East Harlem (EH), NY.
Aim 1 will use qualitative methods to explore the best strategies for using peer education for diabetes risk reduction in youth and the potential role of mobile health technologies in improving adherence to behavioral modification plans.
Aim 2 will utilize findings from preliminary studies and Aim 1 to design and evaluate a pilot community-based intervention to 1) maintain/reduce BMI (primary outcome), 2) improve adolescent dietary, physical activity and weight control behaviors, and 3) improve other measures of diabetes risk.
Data will be collected at baseline, immediately after the intervention (3 months) and at one year in the intervention and wait list control groups.
Aim 3 involves refining the pilot intervention based on an examination of intervention feasibility, acceptability, and sustainability and planning for a future R01.
연구 유형
중재적
등록 (실제)
90
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New York
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New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
13년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria for pre-diabetes screening:
- Adolescents ages 13-19 years of age
- English speaking
Residents of East Harlem or members of an East Harlem Institution. Membership in an East Harlem institution includes the following:
- attending a school in East Harlem
- attending an after school or recreational activity in East Harlem
- receiving health care in East Harlem Proof of address or membership in an East Harlem institution will not be asked.
- At risk for diabetes (overweight/obese based on measured BMI percentile and with either a parent or grandparent with type 2 diabetes)
- No plans to relocate from New York City in the next year
Note: additional inclusion criteria for participation in workshops include diagnosis of pre-diabetes based on oral glucose tolerance test
Exclusion Criteria for pre-diabetes screening:
- <13 or >19 years of age
- Previous diagnosis of diabetes
- BMI percentile <85th percentile for age and gender based on Centers for Disease Control and Prevention definition
- Currently pregnant
- Speaking a language other than English
- On medications that may raise or lower blood sugar
- Plans to relocate from New York City within one year of enrollment-
Note: additional exclusion criteria for participation in workshops include fingerstick glucoses outside the pre-diabetes range during oral glucose tolerance testing and any cognitive or physical impairment that would preclude comprehension of the group educational program
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: TEEN HEED
Adolescent pre-diabetics will receive 8-12 weekly peer-led diabetes prevention educational workshops in community sites.
The in-person group workshops will be supplemented by support through mobile health technologies such as text messaging and social media.
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Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
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간섭 없음: Wait List Control
Adolescent pre-diabetics in this group will not receive any intervention until collection of all follow up data and will then be offered the same intervention as the participants in the experimental arm.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in body mass index (BMI)
기간: Baseline and 3 months
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Change in BMI at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in BMI
기간: Baseline and 1 year
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Change in BMI at 1 year as compared to baseline
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Baseline and 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in fasting blood glucose levels
기간: Baseline and 3 months
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Change in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in fasting blood glucose levels
기간: Baseline and 1 year
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Change in fasting blood glucose levels at 1 year as compared to baseline
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Baseline and 1 year
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Change in post prandial blood glucose level
기간: Baseline and 3 months
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Change in post prandial blood glucose level at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in post prandial blood glucose level
기간: Baseline and 1 year
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Change in post prandial blood glucose level at 1 year as compared to baseline
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Baseline and 1 year
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Change in blood pressure
기간: Baseline and 3 months
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Change in blood pressure at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in blood pressure
기간: Baseline and 1 year
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Change in blood pressure at 1 year as compared to baseline
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Baseline and 1 year
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Change in percent body fat
기간: Baseline and 3 months
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Change in percent body fat at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in percent body fat
기간: Baseline and 1 year
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Change in percent body fat at 1 year as compared to baseline
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Baseline and 1 year
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Change in waist circumference
기간: Baseline and 3 months
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Change in waist circumference at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in waist circumference
기간: Baseline and 1 year
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Change in waist circumference at 1 year as compared to baseline
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Baseline and 1 year
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Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
기간: Baseline and 3 months
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Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
기간: Baseline and 1 year
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Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at 1 year as compared to baseline
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Baseline and 1 year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Nita Vangeepuram, MD, MPH, Icahn School of Medicine at Mount Sinai
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 11월 11일
기본 완료 (실제)
2019년 8월 24일
연구 완료 (실제)
2019년 8월 24일
연구 등록 날짜
최초 제출
2015년 5월 22일
QC 기준을 충족하는 최초 제출
2015년 5월 27일
처음 게시됨 (추정)
2015년 5월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 11월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 11월 20일
마지막으로 확인됨
2019년 11월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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