Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Physical Activity in Women With Infants ("NaMikimiki")

This study has been completed.
Information provided by (Responsible Party):
University of Hawaii Identifier:
First received: December 17, 2008
Last updated: April 16, 2013
Last verified: April 2013

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

Resource links provided by NLM:

Further study details as provided by University of Hawaii:

Primary Outcome Measures:
  • 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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00810342

United States, Hawaii
University of Hawaii School of Nursing
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
University of Hawaii
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 Identifier (NCT Number):
Responsible Party: University of Hawaii 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 processed this record on February 27, 2015