Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The LATCHING Pilot Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03442517
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Breastfeeding Behavioral: Behavior Lifestyle Intervention Other: Usual prenatal care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Learning About Techniques to Create Healthy Infants Through Nutrition and Proper Growth
Actual Study Start Date : April 29, 2017
Actual Primary Completion Date : May 5, 2019
Actual Study Completion Date : May 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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 Name: 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.




Primary Outcome Measures :
  1. Differences in infant feeding progression [ Time Frame: Month 6 ]
  2. Proportion of women exclusively breastfeeding [ Time Frame: Month 6 ]
  3. Proportion of women who introduce solids [ Time Frame: Month 4 ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Study Retention [ Time Frame: Month 6 ]
    Retention rates will be calculated from participants who complete feeding questionnaire data at 6 months.


Other Outcome Measures:
  1. Differences in infant feeding progression [ Time Frame: Week 2 ]
  2. Differences in infant feeding progression [ Time Frame: Month 2 ]
  3. Differences in infant feeding progression [ Time Frame: Month 4 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442517


Locations
Layout table for location information
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Priority Care Pediatrics, LLC
Kansas City, Missouri, United States, 64155
Northland Obstetrics & Gynecology, Inc.
Liberty, Missouri, United States, 64068
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Holly Hull, PhD University of Kansas Medical Center

Layout table for additonal information
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03442517     History of Changes
Other Study ID Numbers: STUDY00140506
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:
group-based counseling
phone counseling
conference calls