Physical Activity in Women With Infants

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

Detailed Description
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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.

Official Title
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Physical Activity in Women With Infants

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: physical activity tailored
* Behavioral: physical activity standard


Participation Criteria
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Eligibility Criteria
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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),

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1- physical activity tailored<br>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. | Behavioral: physical activity tailored<br>* tailored telephone counseling, email feedback, and website resources over 12 months<br>* Other names: tailored exercise advice;|
| Active Comparator: 2 - physical activity standard<br>Standard Website resources / information on physical activity | Behavioral: physical activity standard<br>* standard print and website information on how to become more active<br>* Other names: standard information about physical activity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity standard, exercise