Clinical Trials Directory

Trials / Completed

CompletedNCT00810342

Physical Activity in Women With Infants

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
311 (actual)
Sponsor
University of Hawaii · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALphysical activity tailoredtailored telephone counseling, email feedback, and website resources over 12 months
BEHAVIORALphysical activity standardstandard print and website information on how to become more active

Timeline

Start date
2008-04-01
Primary completion
2012-07-01
Completion
2012-07-01
First posted
2008-12-18
Last updated
2015-06-04
Results posted
2015-06-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00810342. Inclusion in this directory is not an endorsement.