Trial Outcomes & Findings for Physical Activity in Women With Infants (NCT NCT00810342)
NCT ID: NCT00810342
Last Updated: 2015-06-04
Results Overview
Self reported minutes of moderate or vigorous physical activity per week after 12-months
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
311 participants
Primary outcome timeframe
12 months
Results posted on
2015-06-04
Participant Flow
Participant milestones
| Measure |
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
|
2 - Standard
Website resources on physical activity
physical activity: standard print and website information on how to become more active
|
|---|---|---|
|
Month 1 Follow-up
STARTED
|
154
|
157
|
|
Month 1 Follow-up
COMPLETED
|
149
|
155
|
|
Month 1 Follow-up
NOT COMPLETED
|
5
|
2
|
|
6-month Follow-up
STARTED
|
149
|
155
|
|
6-month Follow-up
COMPLETED
|
125
|
147
|
|
6-month Follow-up
NOT COMPLETED
|
24
|
8
|
|
12-month Followup
STARTED
|
125
|
147
|
|
12-month Followup
COMPLETED
|
113
|
136
|
|
12-month Followup
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
| Measure |
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
|
2 - Standard
Website resources on physical activity
physical activity: standard print and website information on how to become more active
|
|---|---|---|
|
Month 1 Follow-up
Lost to Follow-up
|
4
|
2
|
|
Month 1 Follow-up
Pregnancy
|
1
|
0
|
|
6-month Follow-up
Lost to Follow-up
|
18
|
6
|
|
6-month Follow-up
Pregnancy
|
6
|
2
|
|
12-month Followup
Pregnancy
|
9
|
10
|
|
12-month Followup
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Physical Activity in Women With Infants
Baseline characteristics by cohort
| Measure |
1- Tailored
n=154 Participants
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
|
2 - Standard
n=157 Participants
Website resources on physical activity
physical activity: standard print and website information on how to become more active
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 5.5 • n=99 Participants
|
32.1 years
STANDARD_DEVIATION 5.9 • n=107 Participants
|
31.8 years
STANDARD_DEVIATION 5.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=99 Participants
|
157 Participants
n=107 Participants
|
311 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
128 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
252 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
53 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
27 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=99 Participants
|
157 participants
n=107 Participants
|
311 participants
n=206 Participants
|
|
Minutes per week of moderate-to-vigorous physical activity
|
44 minutes per week
n=99 Participants
|
46 minutes per week
n=107 Participants
|
45 minutes per week
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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
Self reported minutes of moderate or vigorous physical activity per week after 12-months
Outcome measures
| Measure |
1- Tailored
n=113 Participants
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
|
2 - Standard
n=136 Participants
Website resources on physical activity
physical activity: standard print and website information on how to become more active
|
|---|---|---|
|
Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months
|
246 minutes per week moderate-to-vigorous PA
Interval 222.0 to 272.0
|
156 minutes per week moderate-to-vigorous PA
Interval 140.0 to 173.0
|
SECONDARY outcome
Timeframe: 12-MonthsPopulation: 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
Participant's physical activity (overall moderate-to-vigorous physical activity above 2.9 metabolic equivalents (METs) collected via an accelerometer over 12 months
Outcome measures
| Measure |
1- Tailored
n=113 Participants
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
|
2 - Standard
n=136 Participants
Website resources on physical activity
physical activity: standard print and website information on how to become more active
|
|---|---|---|
|
Accelerometer Collected Moderate to Vigorous Physical Activity
|
215 minutes per week moderate-to-vigorous PA
Interval 200.0 to 229.0
|
203 minutes per week moderate-to-vigorous PA
Interval 189.0 to 217.0
|
Adverse Events
1- Tailored
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
2 - Standard
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1- Tailored
n=154 participants at risk
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
|
2 - Standard
n=157 participants at risk
Website resources on physical activity
physical activity: standard print and website information on how to become more active
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumor (disorder)
|
0.65%
1/154 • Number of events 1 • 1 year
|
0.00%
0/157 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident (disorder) Blackout (disorder) Spinal cord injury (disorder)
|
0.65%
1/154 • Number of events 1 • 1 year
|
1.3%
2/157 • Number of events 2 • 1 year
|
Other adverse events
| Measure |
1- Tailored
n=154 participants at risk
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
|
2 - Standard
n=157 participants at risk
Website resources on physical activity
physical activity: standard print and website information on how to become more active
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture elbow
|
0.65%
1/154 • Number of events 1 • 1 year
|
0.00%
0/157 • 1 year
|
|
Psychiatric disorders
suicidal thoughts (finding)
|
0.65%
1/154 • Number of events 1 • 1 year
|
0.00%
0/157 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Fracture ribs
|
0.65%
1/154 • Number of events 1 • 1 year
|
0.00%
0/157 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Fracture - Toe
|
0.65%
1/154 • Number of events 1 • 1 year
|
1.3%
2/157 • Number of events 2 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place