Trial Outcomes & Findings for A Home Exercise Program for Women With Infants & Young Children (NCT NCT01738984)
NCT ID: NCT01738984
Last Updated: 2016-04-12
Results Overview
physical activity will be obtained via online surveys at the 12 week assessment point
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
499 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-04-12
Participant Flow
Participant milestones
| Measure |
MomZing Web Program
Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet
|
Standard Exercise DVD
Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant.
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
249
|
|
Overall Study
COMPLETED
|
186
|
210
|
|
Overall Study
NOT COMPLETED
|
64
|
39
|
Reasons for withdrawal
| Measure |
MomZing Web Program
Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet
|
Standard Exercise DVD
Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant.
|
|---|---|---|
|
Overall Study
Pregnancy
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
59
|
39
|
Baseline Characteristics
A Home Exercise Program for Women With Infants & Young Children
Baseline characteristics by cohort
| Measure |
MomZing Web Program
n=250 Participants
Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet
|
Standard Exercise DVD
n=249 Participants
Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant.
|
Total
n=499 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.2 years
STANDARD_DEVIATION 5.2 • n=99 Participants
|
29.4 years
STANDARD_DEVIATION 5.3 • n=107 Participants
|
29.8 years
STANDARD_DEVIATION 5.25 • n=206 Participants
|
|
Sex: Female, Male
Female
|
250 Participants
n=99 Participants
|
249 Participants
n=107 Participants
|
499 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
|
18 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
229 Participants
n=99 Participants
|
212 Participants
n=107 Participants
|
441 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
196 Participants
n=99 Participants
|
207 Participants
n=107 Participants
|
403 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
250 participants
n=99 Participants
|
249 participants
n=107 Participants
|
499 participants
n=206 Participants
|
|
Minutes per week of moderate-to-vigorous of physical activity (MVPA min/wk)
|
66.5 minutes per week
STANDARD_DEVIATION 99.7 • n=99 Participants
|
85.8 minutes per week
STANDARD_DEVIATION 138.3 • n=107 Participants
|
76.15 minutes per week
STANDARD_DEVIATION 119 • n=206 Participants
|
|
Number meeting goal of 150 moderate-to-vigorous min/week
|
45 participants
n=99 Participants
|
71 participants
n=107 Participants
|
116 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksphysical activity will be obtained via online surveys at the 12 week assessment point
Outcome measures
| Measure |
MomZing Web Program
n=186 Participants
Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet
|
Standard Exercise DVD
n=210 Participants
Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant.
|
|---|---|---|
|
Minutes Per Week of Moderate-to-Vigorous Physical Activity (MPVA Min/wk) Assessed at 12 Weeks
|
217.7 MVPA minutes per week
Interval 202.9 to 233.1
|
203.2 MVPA minutes per week
Interval 188.9 to 218.4
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Number of participants who were not smoking at baseline but reported returned to smoking on 12 week survey.
change in smoking status between baseline and 12 week assessment will be collected via survey at baseline and at the 12 week survey
Outcome measures
| Measure |
MomZing Web Program
n=186 Participants
Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet
|
Standard Exercise DVD
n=210 Participants
Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant.
|
|---|---|---|
|
Number Who Returned to Smoking From Baseline and 12 Weeks
|
3 participants
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: number of participants who never/rarely drank at baseline but reported drank 1 or more drink per week at 12 weeks.
drinking status measured via online survey taken at baseline and 12 week
Outcome measures
| Measure |
MomZing Web Program
n=186 Participants
Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet
|
Standard Exercise DVD
n=210 Participants
Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant.
|
|---|---|---|
|
Return to Drinking Between Baseline and 12 Weeks
|
22 participants
|
24 participants
|
Adverse Events
MomZing Web Program
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Standard Exercise DVD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MomZing Web Program
n=250 participants at risk
Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.
MomZing Web Program: Online web platform that is accessed via a television connected to internet
|
Standard Exercise DVD
n=249 participants at risk
Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.
Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant.
|
|---|---|---|
|
Surgical and medical procedures
Emergency appendectomy
|
0.40%
1/250 • Adverse event data collected at 4 and 12 weeks post baseline
data reported by participants via online surveys
|
0.40%
1/249 • Adverse event data collected at 4 and 12 weeks post baseline
data reported by participants via online surveys
|
|
Musculoskeletal and connective tissue disorders
Broken foot bone
|
0.40%
1/250 • Adverse event data collected at 4 and 12 weeks post baseline
data reported by participants via online surveys
|
0.00%
0/249 • Adverse event data collected at 4 and 12 weeks post baseline
data reported by participants via online surveys
|
|
Musculoskeletal and connective tissue disorders
Torn meniscus
|
0.40%
1/250 • Adverse event data collected at 4 and 12 weeks post baseline
data reported by participants via online surveys
|
0.00%
0/249 • Adverse event data collected at 4 and 12 weeks post baseline
data reported by participants via online surveys
|
|
Surgical and medical procedures
Surgery for herniated disk, pinched nerve
|
0.00%
0/250 • Adverse event data collected at 4 and 12 weeks post baseline
data reported by participants via online surveys
|
0.40%
1/249 • Adverse event data collected at 4 and 12 weeks post baseline
data reported by participants via online surveys
|
Additional Information
Cheryl Albright
University of Hawaii, School of Nursing and Dental Hygiene
Phone: 8089569716
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place