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Physical Activity in Women With Infants


Phase 3
18 Years
45 Years
Open (Enrolling)
Female
Physical Activity

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Trial Information

Physical Activity in Women With Infants


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 AHA/ACSM 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.


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),

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

minutes of moderate or vigorous physical activity per week

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Cheryl L Albright, PhD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Hawaii Cancer Research Center

Authority:

United States: Institutional Review Board

Study ID:

CA115614

NCT ID:

NCT00810342

Start Date:

April 2008

Completion Date:

July 2012

Related Keywords:

  • Physical Activity
  • physical activity
  • exercise

Name

Location

University of Hawaii School of Nursing Honolulu, Hawaii  96813