Physical Activity in Women With Infants ("NaMikimiki")

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00810342
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : June 4, 2015
Last Update Posted : June 4, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Hawaii

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

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: physical activity tailored Behavioral: physical activity standard Phase 3

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. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Physical Activity in Women With Infants
Study Start Date : April 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Behavioral: physical activity tailored
tailored telephone counseling, email feedback, and website resources over 12 months
Other Name: tailored exercise advice

Active Comparator: 2 - physical activity standard
Standard Website resources / information on physical activity
Behavioral: physical activity standard
standard print and website information on how to become more active
Other Name: standard information about physical activity

Primary Outcome Measures :
  1. Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months [ Time Frame: 12 months ]
    Self reported minutes of moderate or vigorous physical activity per week after 12-months

Secondary Outcome Measures :
  1. Accelerometer Collected Moderate to Vigorous Physical Activity [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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),

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00810342

United States, Hawaii
University of Hawaii School of Nursing
Honolulu, Hawaii, United States, 96822
Sponsors and Collaborators
University of Hawaii
National Cancer Institute (NCI)
Principal Investigator: Cheryl L Albright, PhD, MPH University of Hawaii, School of Nursing and Dental Hygiene