The LATCHING Pilot Project

Study Overview
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Brief Summary
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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.

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

Conditions
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Breastfeeding

Intervention / Treatment
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* Behavioral: Behavior Lifestyle Intervention
* Other: Usual prenatal care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group-based phone counseling (GBPC)<br>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<br>* 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.<br>* Other names: Group-based phone counseling;|
| Active Comparator: Usual prenatal care<br>Participants will continue their usual prenatal care. | Other: Usual prenatal care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Intervention compliance | Compliance rates will be calculated from participants that attend at least 66.6% (at least 4 sessions) of GBPC sessions. | Week 24 | 
| Study Retention | Retention rates will be calculated from participants who complete feeding questionnaire data at 6 months. | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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group-based counseling, phone counseling, conference calls