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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA115614 | U.S. NIH Grant/Contract | View source | |
| R01CA115614-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is a study testing ways to motivate new mothers to become more physically active over a one year period.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1- physical activity tailored | Experimental | 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. |
|
| 2 - physical activity standard | Active Comparator | Standard Website resources / information on physical activity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical activity tailored | Behavioral | tailored telephone counseling, email feedback, and website resources over 12 months |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl L Albright, PhD, MPH | University of Hawaii, School of Nursing and Dental Hygiene | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hawaii School of Nursing | Honolulu | Hawaii | 96822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25402618 | Derived | 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. | |
| 22533900 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1- Tailored | 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. physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months |
| FG001 | 2 - Standard | Website resources on physical activity physical activity: standard print and website information on how to become more active |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Month 1 Follow-up |
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| |||||||||||||||||||||
| 6-month Follow-up |
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| 12-month Followup |
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Chi square test for differences in proportions; t test for differences in means
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| ID | Title | Description |
|---|---|---|
| BG000 | 1- Tailored | 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. physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Treatment effect was assessed by a mixed growth model and the F test of the fixed 2-way interaction parameter for time and study condition for overall and of the 3-way interaction parameter for characteristic level, time, and study condition. Adjusted for age, race, BMI, education, #children, employment, depression, baby's age, years in Hawaii | Posted | Mean | Inter-Quartile Range | minutes per week moderate-to-vigorous PA | 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1- Tailored | 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. physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracranial tumor (disorder) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | SNOMED CT | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture elbow | Musculoskeletal and connective tissue disorders | SONMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheryl Albright | University of Hawaii, School of Nursing | 8089569716 | cherylal@hawaii.edu |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| physical activity standard | Behavioral | standard print and website information on how to become more active |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| 2 - Standard |
Website resources on physical activity physical activity: standard print and website information on how to become more active |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Minutes per week of moderate-to-vigorous physical activity | Mean | Inter-Quartile Range | minutes per week |
|
| OG001 | 2 - Standard | Website resources on physical activity physical activity: standard print and website information on how to become more active |
|
|
| 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 | Treatment effect was assessed by a mixed growth model and the F test of the fixed 2-way interaction parameter for time and study condition for overall and of the 3-way interaction parameter for characteristic level, time, and study condition. Adjusted for age, race, BMI, education, #children, employment, depression, baby's age, years in Hawaii | Posted | Mean | 95% Confidence Interval | minutes per week moderate-to-vigorous PA | 12-Months |
|
|
|
| 2 |
| 154 |
| 4 |
| 154 |
| EG001 | 2 - Standard | Website resources on physical activity physical activity: standard print and website information on how to become more active | 2 | 157 | 2 | 157 |
| Cerebrovascular accident (disorder) Blackout (disorder) Spinal cord injury (disorder) | Nervous system disorders | SNOMED CT | Systematic Assessment |
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| suicidal thoughts (finding) | Psychiatric disorders | SNOMED CT | Systematic Assessment |
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| Fracture ribs | Musculoskeletal and connective tissue disorders | SONMED CT | Systematic Assessment |
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| Fracture - Toe | Musculoskeletal and connective tissue disorders | SONMED CT | Systematic Assessment |
|
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