Physical Activity in Women With Infants

Physical Activity Clinical Trial

— "NaMikimiki"  

Official title:

Physical Activity in Women With Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810342
• Other study ID #: CA115614
• Secondary ID: 5R01CA115614R01C
• Status: Completed
• Phase: Phase 3
• First received: December 17, 2008
• Last updated: June 1, 2015
• Start date: April 2008
• Est. completion date: July 2012

Study information

• Verified date: January 2015
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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),

Study Design

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

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• physical activity tailored
tailored telephone counseling, email feedback, and website resources over 12 months
• physical activity standard
standard print and website information on how to become more active

Locations

Country	Name	City	State
United States	University of Hawaii School of Nursing	Honolulu	Hawaii

Sponsors (2)

Lead Sponsor	Collaborator
University of Hawaii	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months	Self reported minutes of moderate or vigorous physical activity per week after 12-months	12 months	No
Secondary	Accelerometer Collected Moderate to Vigorous Physical Activity	Participant's physical activity (overall moderate-to-vigorous physical activity above 2.9 metabolic equivalents (METs) collected via an accelerometer over 12 months	12-Months	No