The LATCHING Pilot Project

NCT ID: NCT03442517

Last Updated: 2019-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-29

Study Completion Date

2019-05-05

Brief Summary

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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.

Detailed Description

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Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group-based phone counseling (GBPC)

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

Group Type EXPERIMENTAL

Behavior Lifestyle Intervention

Intervention Type BEHAVIORAL

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.

Usual prenatal care

Participants will continue their usual prenatal care.

Group Type ACTIVE_COMPARATOR

Usual prenatal care

Intervention Type OTHER

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.

Interventions

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Behavior Lifestyle Intervention

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.

Intervention Type BEHAVIORAL

Usual prenatal care

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.

Intervention Type OTHER

Other Intervention Names

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Group-based phone counseling

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holly Hull, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Priority Care Pediatrics, LLC

Kansas City, Missouri, United States

Site Status

Northland Obstetrics & Gynecology, Inc.

Liberty, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34294051 (View on PubMed)

Other Identifiers

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STUDY00140506

Identifier Type: -

Identifier Source: org_study_id

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