- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02631018
Sisters in Health: A Weight Loss Study for African American Women
연구 개요
상태
정황
상세 설명
A disparity exists in the prevalence of overweight and obesity between non-Hispanic white (NHW) and African American (AA) women. More AA women (78.2%) are overweight or obese compared to NHW (61.2%). Obesity increases the risk of developing numerous chronic diseases, including type 2 diabetes (T2DM), hypertension, cardiovascular disease, and some cancers. Among AA women, there is a higher prevalence, and almost double the risk, of developing T2DM compared to NHW. African Americans also have higher rates of complications and mortality from T2DM, and are more at risk for hypertension compared to NHW. Obesity is a costly epidemic. Fortunately, weight is a modifiable risk factor for reducing or preventing obesity and related diseases.
Interventions to reduce overweight and obesity through lifestyle change have been less effective for AA women compared to NHW women. African American women tend to lose less weight in standard behavioral weight loss interventions. A potential reason for smaller weight loss is that compared to NHW women, AA women have been shown to engage in less physical activity (PA) during these interventions.
The Sisters in Health study will test the efficacy of a 6-month randomized controlled trial in overweight and obese African American women. Women will be recruited to participate in this study comparing a standard behavioral weight loss intervention (BWI) to a physical activity enhanced BWI (BWI-PA) for 6 months. The primary objective of this study is to determine if AA women randomized to the BWI-PA will experience greater weight loss and PA compared to women receiving the BWI. Women in both groups will receive 18 face-to-face sessions on a tapered basis (weekly to biweekly). Face-to-face sessions will provide women with the knowledge, behavioral skills and strategies for weight loss.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 21-65 years old
Ability to read, write, and speak English
- Female gender
- African American/Black/African/Afro-Caribbean race (self-identified)
- BMI 25-45 (> 45 may have greater risks while participating)
- Meets criteria for low active (defined as <3 days/week of at most 20 min. of PA/day) assessed by X
- Willingness to be randomized
- Willingness to participate for 6 months, including attending face-to-face sessions & outside of session tasks
- Access to a computer reliable internet access
- Willingness to use an app for diet and physical activity monitoring
- Regularly used email address
- Not planning to relocate
- Able to attend group sessions on scheduled day
Exclusion Criteria:
- Recently lost weight, 5-10% in last 6 months
- Currently participating in another weight loss or PA study, or taking weight loss medication, and unwilling to discontinue those activities
- Pregnant or planning to become pregnant
- Any physical limitations to engaging in or increasing physical activity/exercise- assessed by PAR-Q (including but not limited to heart attack/myocardial infarction, congestive heart failure)
- Type 2 diabetes being treated with insulin
- Major psychological disorder
- History of diagnosed eating disorder
- Medications that affect weight (determined by study staff)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Physical Activity Enhanced Weight Loss Intervention
Participants will engage in 18 weight loss intervention group sessions over 6 months.
Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months.
Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations.
This arm, uniquely, will receive a culturally based physical activity component.
|
18 session, group-based, 6-month, physical activity enhanced behavioral weight loss intervention
|
활성 비교기: Standard Weight Loss Intervention
Participants will engage in 18 weight loss intervention group sessions over 6 months.
Sessions will occur weekly for the first 3 months, and biweekly for the latter 3 months.
Participants will receive a behavioral weight loss curriculum, calorie and physical activity recommendations.
|
18 session, group-based, 6-month, standard behavioral weight loss intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Change in Weight
기간: Baseline to 6 months
|
Baseline to 6 months
|
공동 작업자 및 조사자
수사관
- 연구 의자: Deborah F. Tate, PhD, University of North Carolina, Chapel Hill
- 수석 연구원: Loneke T. Blackman Carr, MA, RD, University of North Carolina, Chapel Hill
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .