Physical Activity in Women With Infants ("NaMikimiki")

University of Hawaii

Status and phase: Completed; Phase 3

Conditions: Physical Activity

Treatments: Behavioral: physical activity standard; Behavioral: physical activity tailored

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00810342

R01CA115614-03S1 (U.S. NIH Grant/Contract)

5R01CA115614 (U.S. NIH Grant/Contract)

CA115614

Details and patient eligibility

About

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

Full 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.

Enrollment: 311 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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),

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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311 participants in 2 patient groups

1- physical activity tailored

Experimental group

Description:

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.

Treatment:

Behavioral: physical activity tailored

2 - physical activity standard

Active Comparator group

Description:

Standard Website resources / information on physical activity

Treatment:

Behavioral: physical activity standard