Physical Activity in Women With Infants ("NaMikimiki")
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Purpose
This is a study testing ways to motivate new mothers to become more physically active over a one year period.
| Condition | Intervention | Phase |
|---|---|---|
|
Physical Activity |
Behavioral: physical activity Behavioral: physical activity information |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Physical Activity in Women With Infants |
- minutes of moderate or vigorous physical activity per week [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Enrollment: | 311 |
| Study Start Date: | April 2008 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.
|
Behavioral: physical activity
telephone counseling, email feedback, and website resources over 12 months
Other Name: exercise advice
|
|
Active Comparator: 2
Website resources on physical activity
|
Behavioral: physical activity information
standard print and website information on how to become more active
Other Name: standard information about physical activity
|
Detailed Description:
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, with maintenance of MVPA evaluated 18-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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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),
Contacts and Locations| United States, Hawaii | |
| University of Hawaii School of Nursing | |
| Honolulu, Hawaii, United States, 96813 | |
| Principal Investigator: | Cheryl L Albright, PhD, MPH | University of Hawaii, School of Nursing and Dental Hygiene |
More Information
No publications provided by University of Hawaii
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Hawaii |
| ClinicalTrials.gov Identifier: | NCT00810342 History of Changes |
| Other Study ID Numbers: | CA115614, 5R01CA115614 |
| Study First Received: | December 17, 2008 |
| Last Updated: | April 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Hawaii:
|
physical activity exercise |
ClinicalTrials.gov processed this record on May 23, 2013