Physical Activity in Women With Infants

NCT ID: NCT00810342

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2012-07-31

Brief 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

Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1- physical activity tailored

Tailored telephone counseling about how to become more physically active and goal setting. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.

Group Type: EXPERIMENTAL

physical activity tailored

Intervention Type: BEHAVIORAL

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

2 - physical activity standard

Standard Website resources / information on physical activity

Group Type: ACTIVE_COMPARATOR

physical activity standard

Intervention Type: BEHAVIORAL

standard print and website information on how to become more active

Interventions

physical activity tailored

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

Intervention Type: BEHAVIORAL

physical activity standard

standard print and website information on how to become more active

Intervention Type: BEHAVIORAL

Other Intervention Names

tailored exercise advice; standard information about physical activity

Eligibility 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),

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheryl L Albright, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii, School of Nursing and Dental Hygiene

Locations

University of Hawaii School of Nursing

Honolulu, Hawaii, United States

Countries

United States

References

Albright CL, Saiki K, Steffen AD, Woekel E. What barriers thwart postpartum women's physical activity goals during a 12-month intervention? A process evaluation of the Na Mikimiki Project. Women Health. 2015;55(1):1-21. doi: 10.1080/03630242.2014.972014. Epub 2015 Jan 30.

Reference Type: DERIVED

PMID: 25402618 (View on PubMed)

Albright CL, Steffen AD, Novotny R, Nigg CR, Wilkens LR, Saiki K, Yamada P, Hedemark B, Maddock JE, Dunn AL, Brown WJ. Baseline results from Hawaii's Na Mikimiki Project: a physical activity intervention tailored to multiethnic postpartum women. Women Health. 2012;52(3):265-91. doi: 10.1080/03630242.2012.662935.

Reference Type: DERIVED

PMID: 22533900 (View on PubMed)

Other Identifiers

5R01CA115614

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01CA115614-03S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CA115614

Identifier Type: -

Identifier Source: org_study_id