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
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding||Behavioral: Behavior Lifestyle Intervention Other: Usual prenatal care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Differences in infant feeding progression [ Time Frame: Month 6 ]
- Proportion of women exclusively breastfeeding [ Time Frame: Month 6 ]
- Proportion of women who introduce solids [ Time Frame: Month 4 ]
- 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.
- 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.
- Study Retention [ Time Frame: Month 6 ]Retention rates will be calculated from participants who complete feeding questionnaire data at 6 months.
- Differences in infant feeding progression [ Time Frame: Week 2 ]
- Differences in infant feeding progression [ Time Frame: Month 2 ]
- Differences in infant feeding progression [ Time Frame: Month 4 ]
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
|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|
|Principal Investigator:||Holly Hull, PhD||University of Kansas Medical Center|