- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00810342
Physical Activity in Women With Infants ("NaMikimiki")
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Hawaii
-
Honolulu, Hawaii, États-Unis, 96822
- University of Hawaii School of Nursing
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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),
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
|
|
Comparateur actif: 2 - physical activity standard
Standard Website resources / information on physical activity
|
standard print and website information on how to become more active
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months
Délai: 12 months
|
Self reported minutes of moderate or vigorous physical activity per week after 12-months
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Accelerometer Collected Moderate to Vigorous Physical Activity
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Cheryl L Albright, PhD, MPH, University of Hawaii, School of Nursing and Dental Hygiene
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CA115614
- 5R01CA115614 (Subvention/contrat des NIH des États-Unis)
- R01CA115614-03S1 (Subvention/contrat des NIH des États-Unis)
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