NCT03480048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 11, 2019

Completed
Last Updated

September 11, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

March 21, 2018

Results QC Date

July 30, 2019

Last Update Submit

August 22, 2019

Conditions

BreastfeedingWeight Loss

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Still Breastfeeding at 20 Weeks Postpartum

    Count of women who report any breastfeeding at 20 weeks postpartum

    20 weeks postpartum

  • Change in Weight From Baseline

    Weight at 20 weeks postpartum minus pre-pregnancy weight.

    Baseline and 20 weeks postpartum

Study Arms (2)

Breastfeeding and weight loss support

EXPERIMENTAL

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

Behavioral: Breastfeeding and weight loss support

Usual care

NO INTERVENTION

Participants receive usual care from their prenatal care provider.

Interventions

Breastfeeding and weight loss supportBEHAVIORAL

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.

Breastfeeding and weight loss support

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMust be pregnant.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Contraindications to breastfeeding, high-risk pregnancy,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System, New Center One Women's Clinic

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • 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.

    PMID: 35166571DERIVED

MeSH Terms

Conditions

Breast FeedingWeight Loss

Interventions

Lactation

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Results Point of Contact

Title
Jean Kerver, PhD, MSc, RD, Assistant Professor
Organization
Michigan State University
jkerver@epi.msu.edu
231-392-8227

Study Officials

  • Jean M Kerver, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2018

First Posted

March 27, 2018

Study Start

March 22, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

September 11, 2019

Results First Posted

September 11, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)