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Completed

NCT Number: NCT03442517

The LATCHING Pilot Project

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavior Lifestyle Intervention

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.

Other names: Group-based phone counseling

Usual Prenatal Care

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 22, 2018
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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