The LATCHING Pilot Project

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442517
• Other study ID #: STUDY00140506
• Status: Completed
• Phase: N/A
• Start date: April 29, 2017
• Est. completion date: May 5, 2019

Study information

• Verified date: May 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 5, 2019
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Priority Care Pediatrics, LLC	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Northland Obstetrics & Gynecology, Inc.	Liberty	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences in infant feeding progression		Week 2
Other	Differences in infant feeding progression		Month 2
Other	Differences in infant feeding progression		Month 4
Primary	Differences in infant feeding progression		Month 6
Primary	Proportion of women exclusively breastfeeding		Month 6
Primary	Proportion of women who introduce solids		Month 4
Secondary	Subject satisfaction and acceptability of intervention	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
Secondary	Intervention compliance	Compliance rates will be calculated from participants that attend at least 66.6% (at least 4 sessions) of GBPC sessions.	Week 24
Secondary	Study Retention	Retention rates will be calculated from participants who complete feeding questionnaire data at 6 months.	Month 6