NCT03442517

Brief Summary

The purpose of this study is to learn if group-based phone counseling is effective for increasing breastfeeding rates, reducing the early introduction of solids and increasing maternal weight loss after pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

April 29, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

December 20, 2017

Last Update Submit

May 29, 2019

Conditions

Breastfeeding

Keywords

group-based counselingphone counselingconference calls

Outcome Measures

Primary Outcomes (3)

  • Differences in infant feeding progression

    Month 6

  • Proportion of women exclusively breastfeeding

    Month 6

  • Proportion of women who introduce solids

    Month 4

Secondary Outcomes (3)

  • Subject satisfaction and acceptability of intervention

    Week 24

  • Intervention compliance

    Week 24

  • Study Retention

    Month 6

Other Outcomes (3)

  • Differences in infant feeding progression

    Week 2

  • Differences in infant feeding progression

    Month 2

  • Differences in infant feeding progression

    Month 4

Study Arms (2)

Group-based phone counseling (GBPC)

EXPERIMENTAL

Participants will take part in weekly group-based phone counseling sessions for 6 weeks starting between 16-30 weeks of pregnancy.

Behavioral: Behavior Lifestyle Intervention

Usual prenatal care

ACTIVE COMPARATOR

Participants will continue their usual prenatal care.

Other: Usual prenatal care

Interventions

Behavior Lifestyle InterventionBEHAVIORAL

Participants will be involved in group-based counseling. Sessions will be about 1 hour each and comprise up to 10 people. The sessions will be led by a trained health educator. The calls will be a chance for participants to discuss challenges with breastfeeding, problem solving skills, educational information, and discuss balanced diet topics.

Also known as: Group-based phone counseling
Group-based phone counseling (GBPC)
Usual prenatal careOTHER

Participants will receive the standard education given by their OBGYN or other healthcare provider. No additional breastfeeding, nutrition or postpartum weight loss education will be provided to participants by the investigators during pregnancy. After delivery, participants will follow normal pediatric visit schedule.

Usual prenatal care

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women who are 9-30 weeks in gestation that have not previously met breastfeeding recommendations
  • Speak and understand English

You may not qualify if:

  • Women with pregnancies conceived using fertility treatments, those at high risk for pre-term delivery, those with multiple gestation (ie. twins, triplets, etc), or pregnancies complicated by morbid obesity (BMI\>40), diabetes (pre-gestational or gestational), hypertension, metabolic dysfunction, etc.
  • Women who have previously exclusively breastfed an infant for three or more months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Priority Care Pediatrics, LLC

Kansas City, Missouri, 64155, United States

Location

Northland Obstetrics & Gynecology, Inc.

Liberty, Missouri, 64068, United States

Location

Related Publications (1)

  • Cauble JS, Herman A, Wick J, Goetz J, Daley CM, Sullivan DK, Hull HR. A prenatal group based phone counseling intervention to improve breastfeeding rates and complementary feeding: a randomized, controlled pilot and feasibility trial. BMC Pregnancy Childbirth. 2021 Jul 22;21(1):521. doi: 10.1186/s12884-021-03976-2.

    PMID: 34294051DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Holly Hull, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2017

First Posted

February 22, 2018

Study Start

April 29, 2017

Primary Completion

May 5, 2019

Study Completion

May 5, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

US(3)