Physical Activity
Conditions
Keywords
physical activity standard, exercise
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.
Interventions
tailored telephone counseling, email feedback, and website resources over 12 months
standard print and website information on how to become more active
Sponsors
Study design
Eligibility
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),
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months | 12 months | Self reported minutes of moderate or vigorous physical activity per week after 12-months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accelerometer Collected Moderate to Vigorous Physical Activity | 12-Months | Participant's physical activity (overall moderate-to-vigorous physical activity above 2.9 metabolic equivalents (METs) collected via an accelerometer over 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 154 |
| 2 - Standard Website resources on physical activity
physical activity: standard print and website information on how to become more active | 157 |
| Total | 311 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-month Followup | Lost to Follow-up | 3 | 1 |
| 12-month Followup | Pregnancy | 9 | 10 |
| 6-month Follow-up | Lost to Follow-up | 18 | 6 |
| 6-month Follow-up | Pregnancy | 6 | 2 |
| Month 1 Follow-up | Lost to Follow-up | 4 | 2 |
| Month 1 Follow-up | Pregnancy | 1 | 0 |
Baseline characteristics
| Characteristic | 1- Tailored | 2 - Standard | Total |
|---|---|---|---|
| Age, Continuous | 31.6 years STANDARD_DEVIATION 5.5 | 32.1 years STANDARD_DEVIATION 5.9 | 31.8 years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 30 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 Participants | 124 Participants | 252 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Minutes per week of moderate-to-vigorous physical activity | 44 minutes per week | 46 minutes per week | 45 minutes per week |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 53 Participants | 52 Participants | 105 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 27 Participants | 24 Participants | 51 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 49 Participants | 49 Participants | 98 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 20 Participants | 27 Participants | 47 Participants |
| Region of Enrollment United States | 154 participants | 157 participants | 311 participants |
| Sex: Female, Male Female | 154 Participants | 157 Participants | 311 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 154 | 2 / 157 |
| serious Total, serious adverse events | 2 / 154 | 2 / 157 |
Outcome results
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
Time frame: 12 months
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 1- Tailored | Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months | 246 minutes per week moderate-to-vigorous PA |
| 2 - Standard | Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months | 156 minutes per week moderate-to-vigorous PA |
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
Time frame: 12-Months
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 1- Tailored | Accelerometer Collected Moderate to Vigorous Physical Activity | 215 minutes per week moderate-to-vigorous PA |
| 2 - Standard | Accelerometer Collected Moderate to Vigorous Physical Activity | 203 minutes per week moderate-to-vigorous PA |