Trial Outcomes & Findings for Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too! (NCT NCT00966381)
NCT ID: NCT00966381
Last Updated: 2023-05-15
Results Overview
The results reported are percent change in total body bone mineral density.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)
Results posted on
2023-05-15
Participant Flow
Participants were recruited from physicians' offices and childbirth classes. Recruitment was from 2008-2010.
Participant milestones
| Measure |
Control
The minimal care group will receive standard public health information on nutrition from the American Heart Association twice during the 16-week intervention. Upon completion of the endpoint measurement (20 wks postpartum), they will be given all intervention materials.
|
Exercise Group
The intervention group will participate in a 16-week exercise and diet intervention from 4 to 20 wks postpartum. The PI will travel to the participant's homes three times per week during the 16-week intervention to guide mothers with the exercise program, ensure dietary compliance, and provide social support. The 16-wk exercise protocol consists of strength training three times per week and walking 10,000 steps per day at least five days per week.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Control
The minimal care group will receive standard public health information on nutrition from the American Heart Association twice during the 16-week intervention. Upon completion of the endpoint measurement (20 wks postpartum), they will be given all intervention materials.
|
Exercise Group
The intervention group will participate in a 16-week exercise and diet intervention from 4 to 20 wks postpartum. The PI will travel to the participant's homes three times per week during the 16-week intervention to guide mothers with the exercise program, ensure dietary compliance, and provide social support. The 16-wk exercise protocol consists of strength training three times per week and walking 10,000 steps per day at least five days per week.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!
Baseline characteristics by cohort
| Measure |
Control
n=15 Participants
The minimal care group will receive standard public health information on nutrition from the American Heart Association twice during the 16-week intervention. Upon completion of the endpoint measurement (20 wks postpartum), they will be given all intervention materials.
|
Exercise Group
n=16 Participants
The intervention group will participate in a 16-week exercise and diet intervention from 4 to 20 wks postpartum. The PI will travel to the participant's homes three times per week during the 16-week intervention to guide mothers with the exercise program, ensure dietary compliance, and provide social support. The 16-wk exercise protocol consists of strength training three times per week and walking 10,000 steps per day at least five days per week.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
31.9 years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
31.1 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)The results reported are percent change in total body bone mineral density.
Outcome measures
| Measure |
Control
n=13 Participants
The minimal care group will receive standard public health information on nutrition from the American Heart Association twice during the 16-week intervention. Upon completion of the endpoint measurement (20 weeks postpartum), they will be given all intervention materials.
Exercise and weight loss intervention: randomized control trial, stratified by parity
|
Exercise Group
n=14 Participants
The intervention group will participate in a 16-week exercise and diet intervention from 4 to 20 weeks postpartum. The PI will travel to the participant's homes three times per week during the 16-week intervention to guide mothers with the exercise program, ensure dietary compliance, and provide social support. The 16-week exercise protocol consists of strength training three times per week and walking 10,000 steps per day at least five days per week.
Exercise and weight loss intervention: randomized control trial, stratified by parity
|
|---|---|---|
|
Bone Mineral Density-Total Body
|
-0.3 percent change in BMD (g/cm2)
Standard Deviation 2.4
|
-1.1 percent change in BMD (g/cm2)
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: Measured at baseline (4 weeks postpartum) and endpoint (20 weeks postpartum)Bone mineral density was measured at the lumbar spine. The results reported are the percent change in bone mineral density.
Outcome measures
| Measure |
Control
n=13 Participants
The minimal care group will receive standard public health information on nutrition from the American Heart Association twice during the 16-week intervention. Upon completion of the endpoint measurement (20 weeks postpartum), they will be given all intervention materials.
Exercise and weight loss intervention: randomized control trial, stratified by parity
|
Exercise Group
n=14 Participants
The intervention group will participate in a 16-week exercise and diet intervention from 4 to 20 weeks postpartum. The PI will travel to the participant's homes three times per week during the 16-week intervention to guide mothers with the exercise program, ensure dietary compliance, and provide social support. The 16-week exercise protocol consists of strength training three times per week and walking 10,000 steps per day at least five days per week.
Exercise and weight loss intervention: randomized control trial, stratified by parity
|
|---|---|---|
|
Bone Mineral Density-lumbar Spine
|
-3.7 percent change in BMD (g/cm^2)
Standard Deviation 3.3
|
-3.4 percent change in BMD (g/cm^2)
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: measured at baseline (4 weeks postpartum) and endpoint (16 weeks postpartum)outcome reported as percent change in percent body fat
Outcome measures
| Measure |
Control
n=13 Participants
The minimal care group will receive standard public health information on nutrition from the American Heart Association twice during the 16-week intervention. Upon completion of the endpoint measurement (20 weeks postpartum), they will be given all intervention materials.
Exercise and weight loss intervention: randomized control trial, stratified by parity
|
Exercise Group
n=14 Participants
The intervention group will participate in a 16-week exercise and diet intervention from 4 to 20 weeks postpartum. The PI will travel to the participant's homes three times per week during the 16-week intervention to guide mothers with the exercise program, ensure dietary compliance, and provide social support. The 16-week exercise protocol consists of strength training three times per week and walking 10,000 steps per day at least five days per week.
Exercise and weight loss intervention: randomized control trial, stratified by parity
|
|---|---|---|
|
Body Composition
|
-6.8 percentage of change in percent fat
Standard Deviation 8.1
|
-8.2 percentage of change in percent fat
Standard Deviation 11.1
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place