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Breastfeeding Support and Weight Management for Black Women

Breastfeeding Support and Weight Management for Black Women: A Dual Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03480048
Acronym
MamaBear
Enrollment
53
Registered
2018-03-27
Start date
2017-03-22
Completion date
2018-11-30
Last updated
2019-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Weight Loss

Brief summary

This study, in African American mothers in Detroit, will test an intervention that combines home visiting by experienced peer counselors with a smart phone-based weight control program. The investigators are trying to help mothers breastfeed their babies longer, and also help them get back to the weight they were before they were pregnant. This trial will help the investigators to guide policies in the state of Michigan and has the potential to improve the health of both mothers and babies everywhere.

Detailed description

Excessive pregnancy-related weight retention is an important determinant of obesity and is more common among African American women. At the same time, breastfeeding, which has been recommended as a strategy to decrease weight retention is lowest among African American women. This racial disparity in breastfeeding may partly explain the disparity in obesity, but even if the two are not causally related, a dual intervention designed to increase breastfeeding duration and decrease postpartum weight retention makes practical sense because both are associated with the same critical postpartum time window. For this study, the investigators will incorporate a postpartum weight management component into an effective breastfeeding support program. This dual intervention will use a combination of in-person, telephone, and interactive web/mobile-based health counseling to provide education and support for breastfeeding difficulties and postpartum weight management. The intervention will be delivered by peer counselors who will be trained to provide support using motivational interviewing techniques with consultation by experts. The investigators have designed the dual intervention to provide encouragement, information, and problem-solving assistance at the appropriate pre or postpartum stage for both breastfeeding support and maternal weight management. The mixed delivery mode has proven effective in other settings and is important to build a trusting relationship while allowing frequent and flexible methods for communicating during this vulnerable time in a new mom's life. The overall goal of this developmental/exploratory R21 proposal is to gather pilot data to effectively refine the intervention so that it can be tested in a larger, longer study using a factorial design in a future R01 phase. The investigators will recruit, in one large inner-city prenatal care clinic (Henry Ford Health System, Detroit, MI), pregnant African American women (32-36 weeks gestation) who are considering breastfeeding (n=80), randomize them to the intervention or to a usual care group, and follow all participants to 20 weeks postpartum. The specific aims are to: 1) test feasibility; 2) assess acceptability; and 3) estimate the effect size of the intervention at 20 weeks postpartum relative to the usual care group on (1) breastfeeding duration and (2) postpartum weight retention. This project is significant because the combined intervention is designed to work synergistically on two interrelated, highly prevalent problems that disproportionately disadvantage African American families.

Interventions

BEHAVIORALBreastfeeding 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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Henry Ford Health System
CollaboratorOTHER
Michigan State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Pregnant, African American women, aged 18 and older, intending to breastfeed, ability to complete surveys in English

Exclusion criteria

* Contraindications to breastfeeding, high-risk pregnancy,

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Still Breastfeeding at 20 Weeks Postpartum20 weeks postpartumCount of women who report any breastfeeding at 20 weeks postpartum
Change in Weight From BaselineBaseline and 20 weeks postpartumWeight at 20 weeks postpartum minus pre-pregnancy weight.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
28
Usual Care
Participants receive usual care from their prenatal care provider.
25
Total53

Baseline characteristics

CharacteristicBreastfeeding and Weight Loss SupportUsual CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
28 Participants25 Participants53 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
28 Participants25 Participants53 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
28 participants25 participants53 participants
Sex: Female, Male
Female
28 Participants25 Participants53 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 180 / 17
other
Total, other adverse events
0 / 180 / 17
serious
Total, serious adverse events
0 / 180 / 17

Outcome results

Primary

Change in Weight From Baseline

Weight at 20 weeks postpartum minus pre-pregnancy weight.

Time frame: Baseline and 20 weeks postpartum

ArmMeasureValue (MEAN)Dispersion
Breastfeeding and Weight Loss SupportChange in Weight From Baseline1.5 poundsStandard Deviation 19.2
Usual CareChange in Weight From Baseline11.7 poundsStandard Deviation 22.3
Primary

Number of Participants Still Breastfeeding at 20 Weeks Postpartum

Count of women who report any breastfeeding at 20 weeks postpartum

Time frame: 20 weeks postpartum

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Breastfeeding and Weight Loss SupportNumber of Participants Still Breastfeeding at 20 Weeks Postpartum9 Participants
Usual CareNumber of Participants Still Breastfeeding at 20 Weeks Postpartum8 Participants

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026