Trial Outcomes & Findings for Breastfeeding Support and Weight Management for Black Women (NCT NCT03480048)
NCT ID: NCT03480048
Last Updated: 2019-09-11
Results Overview
Count of women who report any breastfeeding at 20 weeks postpartum
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
20 weeks postpartum
Results posted on
2019-09-11
Participant Flow
Participant milestones
| Measure |
Breastfeeding and Weight Loss Support
Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.
Breastfeeding and weight loss support: The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss.
|
Usual Care
Participants receive usual care from their prenatal care provider.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
25
|
|
Overall Study
COMPLETED
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Breastfeeding Support and Weight Management for Black Women
Baseline characteristics by cohort
| Measure |
Breastfeeding and Weight Loss Support
n=28 Participants
Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.
Breastfeeding and weight loss support: The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss.
|
Usual Care
n=25 Participants
Participants receive usual care from their prenatal care provider.
|
Total
n=53 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
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
25 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 weeks postpartumCount of women who report any breastfeeding at 20 weeks postpartum
Outcome measures
| Measure |
Breastfeeding and Weight Loss Support
n=18 Participants
Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.
Breastfeeding and weight loss support: The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss.
|
Usual Care
n=17 Participants
Participants receive usual care from their prenatal care provider.
|
|---|---|---|
|
Number of Participants Still Breastfeeding at 20 Weeks Postpartum
|
9 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Baseline and 20 weeks postpartumWeight at 20 weeks postpartum minus pre-pregnancy weight.
Outcome measures
| Measure |
Breastfeeding and Weight Loss Support
n=18 Participants
Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.
Breastfeeding and weight loss support: The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss.
|
Usual Care
n=17 Participants
Participants receive usual care from their prenatal care provider.
|
|---|---|---|
|
Change in Weight From Baseline
|
1.5 pounds
Standard Deviation 19.2
|
11.7 pounds
Standard Deviation 22.3
|
Adverse Events
Breastfeeding and Weight Loss Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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
Jean Kerver, PhD, MSc, RD, Assistant Professor
Michigan State University
Phone: 231-392-8227
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place