- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00810342
Physical Activity in Women With Infants ("NaMikimiki")
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
Hawaii
-
Honolulu, Hawaii, Förenta staterna, 96822
- University of Hawaii School of Nursing
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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),
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
tailored telephone counseling, email feedback, and website resources over 12 months
Andra namn:
|
Aktiv komparator: 2 - physical activity standard
Standard Website resources / information on physical activity
|
standard print and website information on how to become more active
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months
Tidsram: 12 months
|
Self reported minutes of moderate or vigorous physical activity per week after 12-months
|
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Accelerometer Collected Moderate to Vigorous Physical Activity
Tidsram: 12-Months
|
Participant's physical activity (overall moderate-to-vigorous physical activity above 2.9 metabolic equivalents (METs) collected via an accelerometer over 12 months
|
12-Months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Cheryl L Albright, PhD, MPH, University of Hawaii, School of Nursing and Dental Hygiene
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CA115614
- 5R01CA115614 (U.S.S. NIH-anslag/kontrakt)
- R01CA115614-03S1 (U.S.S. NIH-anslag/kontrakt)
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