- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00810342
Physical Activity in Women With Infants ("NaMikimiki")
연구 개요
상세 설명
Mothers of an infant are much less likely to exercise regularly compared with women who have older children or no children. This low level of physical activity (PA) contributes to postpartum weight retention which can predict levels of obesity up to 15 years later. Ethnic minorities have higher rates of inactivity and gain more weight following childbirth, which places them at increased risk for cancer and other chronic diseases consistent with known health disparities for these ethnic groups. Few PA interventions have been designed to increase PA in women with an infant, especially ethnic minority women. This study will test the efficacy of a tailored intervention to increase and maintain PA in a multiethnic population of 268 young, healthy postpartum women living in Hawaii. Women will be recruited from health care settings, mother/baby support groups, and from the media campaigns(TV, radio, newspaper, parents magazines). Subjects will be randomly assigned to either a tailored postpartum counseling intervention on PA or standard care for PA. The tailored PA intervention will address key personal, social, and environmental factors derived from Social Cognitive Theory and the Transtheoretical Model. Also, multimodal contacts (telephone, e-mail, website) will be used to deliver theoretically-derived, culturally sensitive PA counseling,behavioral skills training (e.g., goal setting), and local resources/referrals tailored to a mother with an infant. The standard care condition receives American Heart Association/American College of Sports Medicine print materials/e-mails and referral to PA internet resources.
The primary PA outcome is minutes of moderate/vigorous physical activity (MVPA) per week, as measured by the Active Australia Questionnaire, with validation by accelerometers worn by all subjects. Condition differences in the initiation of PA will be tested at 6 and 12 months post-baseline. Key psychosocial, physiological, and cultural factors will be tested as mediators or moderators of PA, for example: self-efficacy, social support, processes of change, ethnicity, BMI, and cultural values. This study will serve as a model for the design and implementation of PA interventions for at-risk ethnic minority postpartum women.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Hawaii
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Honolulu, Hawaii, 미국, 96822
- University of Hawaii School of Nursing
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- mother of infant aged 2-12 months
- sedentary
- healthy, able to do moderate intensity physical activity
- BMI = 18.5-40
- not planning to become pregnant in next year
- woman aged 18-45
- able speak and read English
Exclusion Criteria:
- pregnant
- planning to leave Oahu, Hawaii in the next year (permanently move away)
- a diagnosis of cancer, coronary heart disease (including atrial fibrillation), insulin-dependent diabetes mellitus (IDDM), and other atherosclerotic cardiovascular diseases (e.g., stroke),
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 1- physical activity tailored
Tailored telephone counseling about how to become more physically active and goal setting.
Email feedback on physical activity progress.
Website listing resources new mothers can use to become more active.
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tailored telephone counseling, email feedback, and website resources over 12 months
다른 이름들:
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활성 비교기: 2 - physical activity standard
Standard Website resources / information on physical activity
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standard print and website information on how to become more active
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months
기간: 12 months
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Self reported minutes of moderate or vigorous physical activity per week after 12-months
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Accelerometer Collected Moderate to Vigorous Physical Activity
기간: 12-Months
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Participant's physical activity (overall moderate-to-vigorous physical activity above 2.9 metabolic equivalents (METs) collected via an accelerometer over 12 months
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12-Months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Cheryl L Albright, PhD, MPH, University of Hawaii, School of Nursing and Dental Hygiene
간행물 및 유용한 링크
일반 간행물
- Albright CL, Saiki K, Steffen AD, Woekel E. What barriers thwart postpartum women's physical activity goals during a 12-month intervention? A process evaluation of the Na Mikimiki Project. Women Health. 2015;55(1):1-21. doi: 10.1080/03630242.2014.972014. Epub 2015 Jan 30.
- Albright CL, Steffen AD, Novotny R, Nigg CR, Wilkens LR, Saiki K, Yamada P, Hedemark B, Maddock JE, Dunn AL, Brown WJ. Baseline results from Hawaii's Na Mikimiki Project: a physical activity intervention tailored to multiethnic postpartum women. Women Health. 2012;52(3):265-91. doi: 10.1080/03630242.2012.662935.
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CA115614
- 5R01CA115614 (미국 NIH 보조금/계약)
- R01CA115614-03S1 (미국 NIH 보조금/계약)
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. .
신체 활동에 대한 임상 시험
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University Hospital, Grenoble완전한관절만곡증 Amyoplasia 또는 원위 관절만곡증의 진단 | National Reference Center의 AMC Clinic에서 5일 다학제 평가 | Grenoble Alpes 병원의 Physical Medecin, Medical Genetic and Imaging 부서와 함께프랑스
physical activity tailored에 대한 임상 시험
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Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)완전한
-
Foundation University Islamabad모병
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Karolinska InstitutetEvira AB완전한
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Oslo University HospitalThe Research Council of Norway완전한림프종 | 백혈병 | 암 | 줄기세포 이식