Scale-Up Evaluation Trial of the Diabetes Prevention Program to Improve Obesity and Cardiometabolic Health After Traumatic Brain Injury (GLB Scale-Up)
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Alexandria Suhalka, MPH
- 전화번호: 214-865-2496
- 이메일: Alexandria.Suhalka@BSWHealth.org
연구 연락처 백업
- 이름: Shahad Alrawi, MS
- 전화번호: 214-820-9324
- 이메일: Shahad.Arawi@BSWHealth.org
연구 장소
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Texas
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Dallas, Texas, 미국, 75204
- Baylor Scott & White Research Institute
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
18-80 years of age
-≥6 months post-TBI
- Moderate to severe TBI at time of injury
- BMI ≥25 kg/m2
- Able to communicate in English
Exclusion Criteria:
- Contraindications to physical activity
- Low cognitive function
- Residing in hospital, acute rehab, SNF
- Self-Reported Pregnancy
- Pre-existing diagnosis of an eating disorder
- Former DPP-GLB Participants (less than 6months since participation ended)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Cohort 1
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. Cohorts consist of 8-10 people. |
The GLB-TBI is a one-year program with 22 sessions.
It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
|
|
Cohort 2
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. Cohorts consist of 8-10 people. |
The GLB-TBI is a one-year program with 22 sessions.
It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
|
|
Cohort 3
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. Cohorts consist of 8-10 people. |
The GLB-TBI is a one-year program with 22 sessions.
It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
|
|
Cohort 4
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. Cohorts consist of 8-10 people. |
The GLB-TBI is a one-year program with 22 sessions.
It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
|
|
Cohort 5
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. Cohorts consist of 8-10 people. |
The GLB-TBI is a one-year program with 22 sessions.
It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
|
|
Cohort 6
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. Cohorts consist of 8-10 people. |
The GLB-TBI is a one-year program with 22 sessions.
It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
|
|
Cohort 7
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. Cohorts consist of 8-10 people. |
The GLB-TBI is a one-year program with 22 sessions.
It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
|
|
Cohort 8
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. Cohorts consist of 8-10 people. |
The GLB-TBI is a one-year program with 22 sessions.
It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
|
|
Cohort 9
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. Cohorts consist of 8-10 people. |
The GLB-TBI is a one-year program with 22 sessions.
It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.
The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body Weight
기간: Baseline and 12 months
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Body weight will be measured at each session using an accessible scale.
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Baseline and 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood Pressure
기간: Baseline and 12 months
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Using an automatic cuff diastolic and systolic scores will be obtained either in person or via Quest Diagnostics.
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Baseline and 12 months
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Hemoglobin A1c
기간: Baseline and 12 months
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Blood sample will be obtained either in person or via Quest Diagnostics.
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Baseline and 12 months
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Fasting Blood Glucose
기간: Baseline and 12 months
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Blood sample will be obtained either in person or via Quest Diagnostics.
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Baseline and 12 months
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Lipid Panel
기간: Baseline and 12 months
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Blood sample will be obtained either in person or via Quest Diagnostics.
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Baseline and 12 months
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Self-Efficacy
기간: Baseline and 12 months
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Self reported measure using the Self-Rated Abilities for Health Practice scale.
Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices Score plus 4 subscale scores regarding Exercise, Nutrition, Health Practices, and Psychological Well Being.
Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.'
Scores range from 0-28 with higher scores indicating higher exercise self-efficacy.
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Baseline and 12 months
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Exit Survey
기간: 12 months
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Participants will be asked to complete Exit Survey at the 12-month assessment.
This survey will ask about participant experience in, and satisfaction with, the GLB-TBI program and suggestions for improvement.
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Evan McShan, PhD, Baylor Scott & White Research Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 026-349
- 90IFRE0110 (기타 보조금/기금 번호: National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
뇌 손상, 외상성에 대한 임상 시험
-
University of Dublin, Trinity College알려지지 않은Brain Health 은퇴 엘리트 선수