The LATCHING Pilot Project

May 29, 2019 updated by: University of Kansas Medical Center

Learning About Techniques to Create Healthy Infants Through Nutrition and Proper Growth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64155
        • Priority Care Pediatrics, LLC
      • Liberty, Missouri, United States, 64068
        • Northland Obstetrics & Gynecology, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Other Names:
  • Group-based phone counseling
Active Comparator: Usual prenatal care
Participants will continue their usual prenatal care.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in infant feeding progression
Time Frame: Month 6
Month 6
Proportion of women exclusively breastfeeding
Time Frame: Month 6
Month 6
Proportion of women who introduce solids
Time Frame: Month 4
Month 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject satisfaction and acceptability of intervention
Time Frame: Week 24
Structured interviews will be used to determine subject satisfaction. Structured interviews will obtain descriptive data regarding problems encountered by participants during the intervention, areas of intervention strength and weakness, information participants found helpful and information participants wish they had been given during the intervention, and ways the overall intervention could be improved.
Week 24
Intervention compliance
Time Frame: Week 24
Compliance rates will be calculated from participants that attend at least 66.6% (at least 4 sessions) of GBPC sessions.
Week 24
Study Retention
Time Frame: Month 6
Retention rates will be calculated from participants who complete feeding questionnaire data at 6 months.
Month 6

Other Outcome Measures

Outcome Measure
Time Frame
Differences in infant feeding progression
Time Frame: Week 2
Week 2
Differences in infant feeding progression
Time Frame: Month 2
Month 2
Differences in infant feeding progression
Time Frame: Month 4
Month 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2017

Primary Completion (Actual)

May 5, 2019

Study Completion (Actual)

May 5, 2019

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

February 20, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 29, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00140506

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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