Physical Activity in Women With Infants ("NaMikimiki")

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Hawaii
ClinicalTrials.gov Identifier:
NCT00810342
First received: December 17, 2008
Last updated: April 16, 2013
Last verified: April 2013

December 17, 2008
April 16, 2013
April 2008
July 2012   (final data collection date for primary outcome measure)
minutes of moderate or vigorous physical activity per week [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00810342 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Physical Activity in Women With Infants
Physical Activity in Women With Infants

This is a study testing ways to motivate new mothers to become more physically active over a one year period.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Physical Activity
  • Behavioral: physical activity
    telephone counseling, email feedback, and website resources over 12 months
    Other Name: exercise advice
  • Behavioral: physical activity information
    standard print and website information on how to become more active
    Other Name: standard information about physical activity
  • 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.
    Intervention: Behavioral: physical activity
  • Active Comparator: 2
    Website resources on physical activity
    Intervention: Behavioral: physical activity information
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 Nā Mikimiki Project: a physical activity intervention tailored to multiethnic postpartum women. Women Health. 2012;52(3):265-91. doi: 10.1080/03630242.2012.662935.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
311
July 2012
July 2012   (final data collection date for primary outcome measure)

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),
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00810342
CA115614, 5R01CA115614
Yes
University of Hawaii
University of Hawaii
Not Provided
Principal Investigator: Cheryl L Albright, PhD, MPH University of Hawaii, School of Nursing and Dental Hygiene
University of Hawaii
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP