Physical Activity
Conditions
Keywords
Cellular phone, exercise, pregnant women, obesity, overweight, physical activity
Brief summary
Obesity among women of childbearing age and excessive weight gain during pregnancy are prevalent and steadily increasing health care issues. Regular physical activity is recommended to maintain healthy weight gain for pregnant women, however, a majority of pregnant women are sedentary. The investigators proposed to conduct a pilot study to estimate the potential efficacy of a mobile phone based physical activity intervention in 30 physically inactive pregnant women.
Interventions
BEHAVIORALMobile phone-based physical activity
Participants will receive the mobile phone-based physical activity program using the trial app.
BEHAVIORALActivity monitor
Participants will receive an activity monitor
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* pregnant, gestational week (10-20 weeks) * pre-pregnancy BMI ≥ 18.5 kg•m2 * physically inactive at work and during leisure time * intent to be physically active * access to a home telephone or a mobile phone * have a personal computer access * ability to communicate (speak and read) in English.
Exclusion criteria
* known medical or obstetric complication that restricts physical activity * history of eating disorders * current participation in lifestyle modification programs * history of bariatric surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Monitor Measured Steps | 12 weeks | Change in weekly mean steps per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Physical Activity Recall | 12 weeks | Change in mean energy expenditure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mobile App Plus Activity Monitor Group Participants in the group will receive a study mobile phone application and an activity monitor
Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention. | 15 |
| Activity Monitor Group Participants in the group will receive an activity monitor | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Mobile App Plus Activity Monitor Group | Activity Monitor Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Continuous | 32.9 years STANDARD_DEVIATION 2.5 | 34.5 years STANDARD_DEVIATION 2.5 | 33.7 years STANDARD_DEVIATION 2.6 |
| Race/Ethnicity, Customized Race Asian | 5 Participants | 7 Participants | 12 Participants |
| Race/Ethnicity, Customized Race Black | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Hispanic/Latina | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White | 7 Participants | 6 Participants | 13 Participants |
| Region of Enrollment United States | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 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 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Physical Activity Monitor Measured Steps
Change in weekly mean steps per day
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile App Plus Activity Monitor Group | Physical Activity Monitor Measured Steps | Baseline to week 5-8 | 1092.1 step | Standard Deviation 1925.3 |
| Mobile App Plus Activity Monitor Group | Physical Activity Monitor Measured Steps | Baseline to week 1-4 | 1166.6 step | Standard Deviation 1709.4 |
| Mobile App Plus Activity Monitor Group | Physical Activity Monitor Measured Steps | Baseline to week 9-12 | 1096.2 step | Standard Deviation 1898.1 |
| Activity Monitor Group | Physical Activity Monitor Measured Steps | Baseline to week 5-8 | 804.3 step | Standard Deviation 1752.9 |
| Activity Monitor Group | Physical Activity Monitor Measured Steps | Baseline to week 9-12 | 258.7 step | Standard Deviation 1603.7 |
| Activity Monitor Group | Physical Activity Monitor Measured Steps | Baseline to week 1-4 | 1062.6 step | Standard Deviation 2325.5 |
Secondary
7-Day Physical Activity Recall
Change in mean energy expenditure
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile App Plus Activity Monitor Group | 7-Day Physical Activity Recall | 69 kcal/day | Standard Deviation 223.1 |
| Activity Monitor Group | 7-Day Physical Activity Recall | 204.3 kcal/day | Standard Deviation 314.7 |