Full Text View
Tabular View
No Study Results Posted
Related Studies
Physical Activity in Women With Infants ("NaMikimiki")
This study is currently recruiting participants.
Verified by University of Hawaii, December 2008
First Received: December 17, 2008   No Changes Posted
Sponsored by: University of Hawaii
Information provided by: University of Hawaii
ClinicalTrials.gov Identifier: NCT00810342
  Purpose

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


Condition Intervention Phase
Physical Activity
Behavioral: physical activity
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: Physical Activity in Women With Infants

Resource links provided by NLM:


Further study details as provided by University of Hawaii:

Primary Outcome Measures:
  • minutes of moderate or vigorous physical activity per week [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: April 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.
Behavioral: physical activity
telephone counseling, email feedback, and website resources over 12 months
2: Active Comparator
Website resources on physical activity
Behavioral: physical activity
telephone counseling, email feedback, and website resources over 12 months

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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),
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810342

Contacts
Contact: Cheryl L Albright, PhD, MPH 808 441 8189 calbright@crch.hawaii.edu
Contact: Kara Saiki, MS 808 4418187 ksaiki@crch.hawaii.edu

Locations
United States, Hawaii
Cancer Research Center of Hawaii Recruiting
Honolulu, Hawaii, United States, 96822
Contact: Sandy French     808-564-5978        
Sub-Investigator: Claudio Nigg, PhD            
Sub-Investigator: Rachel Novotny, PhD            
Sub-Investigator: Jason Maddock, PhD            
Sub-Investigator: Lynne Wilkens, PhD            
Sponsors and Collaborators
University of Hawaii
Investigators
Principal Investigator: Cheryl L Albright, PhD, MPH University of Hawaii Cancer Research Center
  More Information

No publications provided

Responsible Party: Cancer Research Center of Hawaii; University of Hawaii ( Associate Researcher )
Study ID Numbers: CA115614, 5R01CA115614
Study First Received: December 17, 2008
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00810342     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Hawaii:
physical activity
exercise

ClinicalTrials.gov processed this record on September 03, 2009