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Completed

NCT Number: NCT00810342

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Hawaii School of Nursing

Honolulu, Hawaii, 96822, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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),

Treatment and study plan

physical activity tailored

Behavioral

tailored telephone counseling, email feedback, and website resources over 12 months

Other names: tailored exercise advice

physical activity standard

Behavioral

standard print and website information on how to become more active

Other names: standard information about physical activity

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: "NaMikimiki"

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 18, 2008
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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