CClinicalTrials.gg
CompletedNCT03480048MamaBearUpdated Sep 11, 2019Results posted

Breastfeeding Support and Weight Management for Black Women

An interventional study of Breastfeeding and weight loss support in Breastfeeding and Weight Loss, sponsored by Michigan State University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-11.

Sponsored by Michigan State University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breastfeeding
  • Weight Loss
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Contraindications to breastfeeding, high-risk pregnancy,
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Breastfeeding and weight loss support

    Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.

    Behavioral: Breastfeeding and weight loss support

  • No intervention
    Usual care

    Participants receive usual care from their prenatal care provider.

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.

05

What researchers measure

Primary outcomes

  1. 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

  2. Change in Weight From Baseline

    Weight at 20 weeks postpartum minus pre-pregnancy weight.

    Time frame: Baseline and 20 weeks postpartum

06

Results

Posted Sep 11, 2019

Participant flow

Participant flow — Overall Study
MilestoneBreastfeeding and Weight Loss SupportUsual Care
Started2825
Completed1817
Not completed108

Outcome measures

PrimaryNumber of Participants Still Breastfeeding at 20 Weeks Postpartum

Count of women who report any breastfeeding at 20 weeks postpartum

Time frame:
20 weeks postpartum
Reported as:
Count of participants · Participants
Number of Participants Still Breastfeeding at 20 Weeks Postpartum
ParticipantsBreastfeeding and Weight Loss SupportUsual Care
Number of Participants Still Breastfeeding at 20 Weeks Postpartum98
PrimaryChange in Weight From Baseline

Weight at 20 weeks postpartum minus pre-pregnancy weight.

Time frame:
Baseline and 20 weeks postpartum
Reported as:
Mean · pounds
Change in Weight From Baseline
poundsBreastfeeding and Weight Loss SupportUsual Care
Change in Weight From Baseline1.5 ± 19.211.7 ± 22.3

Adverse events

Collected over From study enrollment during late pregnancy through 20 weeks postpartum, or about 6-7 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Breastfeeding and Weight Loss Support0/18 (0%)0/18 (0%)0/18 (0%)
Usual Care0/17 (0%)0/17 (0%)0/17 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Breastfeeding and Weight Loss SupportUsual CareTotal
<=18 years000
Between 18 and 65 years282553
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Breastfeeding and Weight Loss SupportUsual CareTotal
Female282553
Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Breastfeeding and Weight Loss SupportUsual CareTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American282553
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Breastfeeding and Weight Loss SupportUsual CareTotal
United States282553
07

Study locations

1 site
  • Henry Ford Health System, New Center One Women's Clinic
    Detroit, Michigan 48202, United States
08

References and documents

Publications

  • Shipp GM, Weatherspoon LJ, Comstock SS, Norman GS, Alexander GL, Gardiner JC, Kerver JM. Breastfeeding Self-Efficacy as a Predictor of Breastfeeding Intensity Among African American Women in the Mama Bear Feasibility Trial. Breastfeed Med. 2022 May;17(5):453-458. doi: 10.1089/bfm.2021.0301. Epub 2022 Feb 15. PubMed 35166571 ↗

Study documents

  • Protocol, analysis plan and consent form · Feb 28, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03480048
Lead sponsor
Michigan State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Henry Ford Health System
Responsible party
Jean Kerver (Assistant Professor, Michigan State University) — Principal investigator
First posted
Mar 27, 2018
Start date
Mar 22, 2017
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018
Results posted
Sep 11, 2019
Last update
Sep 11, 2019

Study contacts

Jean M Kerver, PhD
principal investigator · Michigan State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion