Breastfeeding Support and Weight Management for Black Women (MamaBear)
Primary Purpose
Breastfeeding, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breastfeeding and weight loss support
Sponsored by
About this trial
This is an interventional supportive care trial for Breastfeeding
Eligibility Criteria
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,
Sites / Locations
- Henry Ford Health System, New Center One Women's Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Breastfeeding and weight loss support
Usual care
Arm Description
Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.
Participants receive usual care from their prenatal care provider.
Outcomes
Primary Outcome Measures
Number of Participants Still Breastfeeding at 20 Weeks Postpartum
Count of women who report any breastfeeding at 20 weeks postpartum
Change in Weight From Baseline
Weight at 20 weeks postpartum minus pre-pregnancy weight.
Secondary Outcome Measures
Full Information
NCT ID
NCT03480048
First Posted
March 21, 2018
Last Updated
August 22, 2019
Sponsor
Michigan State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT03480048
Brief Title
Breastfeeding Support and Weight Management for Black Women
Acronym
MamaBear
Official Title
Breastfeeding Support and Weight Management for Black Women: A Dual Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Weight Loss
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breastfeeding and weight loss support
Arm Type
Experimental
Arm Description
Participants receive a combination of in-person, phone, and online support for breastfeeding and postpartum weight management.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants receive usual care from their prenatal care provider.
Intervention Type
Behavioral
Intervention Name(s)
Breastfeeding and weight loss support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Still Breastfeeding at 20 Weeks Postpartum
Description
Count of women who report any breastfeeding at 20 weeks postpartum
Time Frame
20 weeks postpartum
Title
Change in Weight From Baseline
Description
Weight at 20 weeks postpartum minus pre-pregnancy weight.
Time Frame
Baseline and 20 weeks postpartum
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Must be pregnant.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean M Kerver, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health System, New Center One Women's Clinic
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35166571
Citation
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.
Results Reference
derived
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Breastfeeding Support and Weight Management for Black Women
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