Introduction to Clinical Translational Research Course Small Group Research

Introduction to Clinical/Translational Research Course Small Group Research Protocol Improving Breast Feeding Through a Community-Based Peer Counseling Intervention Team Members: Ayad Ali; Daniela Hurtado; Jonathan Ruwe; Marianella Natera; Maryam Sattari; Namjik Cho; Rajeeb Das; Shawna Dell; Thomas Buford Discussion Leaders: Caprice Knapp, Ph. D; Ronald Shorr, MD, MS Library Liaison: July 28, 2010 Linda Butson, MLn, MPH

Presentation Outline • Specific Aims. • Background & Significance. • Methods: - Setting. - Population. - Intervention. - Peer Counselor Training. • Data Collection. • Statistical Analysis Plan. • References. 1

Specific Aims • Specific Aim 1: To determine the effectiveness of a community based, peer counseling intervention designed to increase breastfeeding rates in low income women. • Specific Aim 2: To determine how the effectiveness of the intervention varies by household factors such as race/ethnicity & age. • Specific Aim 3: To determine how the effectiveness of the intervention varies by health delivery factors. R 01 Grant: “Reducing Health Disparities Among Minority and Underserved Children” National Institute of Nursing Research 2

Background “American Academy of Pediatrics recommends that infants in the United States be exclusively breastfed for 6 months after birth followed by the introduction of appropriate complementary foods & continued breastfeeding until at least 12 months of age” Nutritional and health benefits of breastfeeding (BF): • Provides the ideal nutrition for infants. • Provides significant developmental benefits. • Decreases the risk for acute and chronic diseases. • Offers unique immunologic benefits to the infant. • One of the most effective preventive health measures available to reduce child morbidity and mortality. • Promotion of mother-infant interaction and bonding. 3

Background Cont. WHO/UNICEF Baby-Friendly Hospital Initiative: The 10 Steps 1. Written BF promotion policies 2. BF training for all health personnel 3. Prenatal BF promotion 4. BF initiation within 30 min postpartum 5. BF counseling to mothers in maternity wards 6. Breast milk only for newborns 7. Rooming in - remain together 24 hours a day 8. BF on demand 9. No baby bottles or pacifiers 10. Community-based postnatal BF support 4

Background Cont. 5

Background Cont. 6

Methods Setting: To choose the study setting we considered: Ø Poverty Levels = Counties with high levels of poverty in Northern Florida • Putnam County (Poverty Rate=23. 1%) • Union County (23. 6%) • Alachua County (20%) Ø County Hospital that has a Maternity Ward with a high proportion of patients on Medicaid • Putnam Community Medical Center (85% Medicaid Use) • Shands at UF (71% Medicaid Use) Ø Rural setting • Putnam Community Medical Center 7

Percent Medicaid and Breastfeeding Correlation in Florida Counties, Years 2005 to 2008 Putnam County 8

Population: Methods Cont. Ø Inclusion Criteria: - Participating in the Healthy Start Program. - Low income expectant mothers. - Enrolled in Medicaid health insurance program. - Live in Putnam County. - Do not intend to breastfeed as indicated on Healthy Start intake form. Ø Exclusion Criteria: - Age less than 18 and older than 50 years. - Plan to move outside of Putnam within 12 months. - Health conditions that prohibit BF. - Mothers who plan to give birth in a setting outside of the hospital. Study power of 80%, with a 20% expected attrition rate, at least 162 women in each group is required. (Total N= 324) 9

Methods Cont. Community-Based Intervention: • A study has shown that peer counselor interventions were effective in an inner city Latina low-income population: “Well-structured, intensive breastfeeding support provided by hospital and community-based peer counselors is effective in improving exclusive breastfeeding rates among lowincome, inner-city women in the United States” • Our proposed study uses a similar peer counselor intervention, but our population is a rural area and we focus on women from low-income households of a more diverse range of racial/ethnic groups. 10

INTERVENTION TIME FRAME Peer-Counseling <24 wks’ (6 months) gestation Low-Income Pregnant Women Not Intending to Breast Feed Randomization Day 0: Contact to schedule appointments Intervention Control 1 st: Day 7 -15 HOME PRENATAL VISITS 2 nd: <36 th wk 3 rd: 36 th wk IN-HOSPITAL DAILY VISITS POST NATAL VISITS 36 th wk’ (9 months) gestation During Hospitalization for Delivery X 9 3 Months Post Delivery 11

Methods Cont. Peer-Counselors: Ø Identification: Mothers will be recruited by referral from the Healthy Start Coalition Program. Ø Inclusion Criteria for Peer Counselors: – – – Mother. Time availability. Successfully breastfed a child for not less than 6 months From a low income household. Living in the area of interest. 12

Methods Cont. Peer-Counselors: Ø Training: • What? WHO/UNICEF Breastfeeding 40 -hours Counseling Training Course. • Who? Peers will be trained by an international board certified lactation consultant through the International Lactation Consultant Association. • How? Theory (anatomy and physiology of the breast and managing breastfeeding); Role-plays; and hand on practice with mother infant dyads. • Where? At the county health department. • Follow up: Lactation consultants observe counselors for two months during routine ward rounds and home visits. 13

Methods Cont. Prenatal Home Visits: • Peer counselors review: – Benefits and reasons for exclusive breastfeeding – Avoidance of the use of feeding bottles and pacifiers – Behaviors that impede early initiation and successful BF • They also: – Test for inverted nipples – Explain why exclusive breastfeeding babies do not need water during the first 6 months of life – Give infant cues for readiness to breastfeed – Show proper latch-on technique or positioning If the woman has a VHS or DVD player, she is provided with an opportunity to watch a breastfeeding video (UNICEF). The entire family is encouraged to participate in the education, especially the principal person expected to support the woman after delivery. 14

Methods Cont. Postnatal Visits: • Hands-on breastfeeding support and counseling according to mothers’ needs – 1 st week post-partum: 3 visits – 2 nd week post-partum: 2 visits – Once a week from 3 rd to 6 th week post-partum 15

Methods Control Group: • Usual breastfeeding education during the prenatal period from the Florida Healthy Start staff. • Usual hands-on breastfeeding assistance and education from the maternity ward nursing staff at the hospital. 16

Data Collection & Statistical Analysis Plan Data Collection <24 wks’ (6 months) gestation Low-Income Pregnant Women Not Intending to Breast Feed Randomization Baseline Intervention Control 36 th wk’ (9 months) gestation Follow up Delivery day 3 Months Post Delivery 17

Data Collection Ø Data Collection Method: Personal Interviewing. Trained research assistants will interview the women and record the data on standard data collection form (DCF) and Patient Diaries on standardized pictogram-based forms. Ø Frequency of Data Collection: Data will be collected 4 times during the study: - Baseline at index date. - 36 th weeks’ gestation after the index date. - During hospitalization for delivery. - 3 months post delivery date. 18

Statistical Analysis Ø Level of Significance (Type I error rate of 5%). Ø Descriptive Statistics. - Proportions & their 95% Confidence Intervals. - Chi Squared for Categorical Data. - Means and their Standard Deviations. - Independent Sample t-Test for Numerical Data. Ø Inferential Statistics. - Logistic Regression for Categorical Outcome. - OLS Regression for Continuous Outcome. - Controlling for Confounding Variables. Y = α + βX + γZ + ε 19

Variable Definitions Variable Scale Range Source Measurement Schedule Outcomes: • BF Duration (months) Numerical <3 Diaries Post delivery follow up. • BF Frequency (No. of Numerical … Diaries Post delivery follow up. … Index date BF/month) Exposure: • Peer-Counseling vs. standard care. Categorical 0 -1 20

Variable Definitions Cont. Covariates Scale Range Source Measurement Schedule 18 -50 … 0 -1 DCF DCF Baseline Demographics: • Age (years) • Race • Ethnicity • Marital Status Numerical Categorical Socioeconomic Status: • Household Income (US$) • Highest Educational Degree • Have WIC benefit? Categorical … Categorical 0 -1 DCF DCF Baseline Numerical DCF DCF Baseline Maternity Information: • Number of Children • Number of Pregnancies • Number of Children Fed on Baby Formulas. … 21

Variable Definitions Cont. Covariates Cont. Scale Range Source Measurement Schedule Health Status: • Chronic Illnesses. • Chronic Medications. • Delivery Due Date. Categorical 0 -1 Categorical Date DCF DCF Baseline Health Literacy: • BF Knowledge (Benefits) • Physician Trust. Categorical 0 -1 DCF Baseline DCF Diaries Delivery Date Delivery & Post Health System Factors: • Nurse Informed about BF. Categorical 0 -1 • Availability of Baby Formulas Categorical 0 -1 • Frequency of Baby Formula Categorical … Use (No. of Bottles Fed/Week) Delivery Follow up 22

References 1. Source: American Academy of Pediatrics, Work Group on Breastfeeding. (1997) Breastfeeding and the use of human milk. Pediatrics. 100: 10351039. 2. Anderson, A. K. (2005) A Randomized Trial Assessing the Efficacy of Peer Counseling on Exclusive Breastfeeding in a Predominantly Latina Low-Income Community, Arch Pediatr Adolesc Med. 159: 836 -841 3. Abrahams, S. W. (2009 ) Exploring the impact of the Baby-Friendly Hospital Initiative on trends in exclusive breastfeeding, International Breastfeeding Journal, 4: 11 doi: 10. 1186/1746 -4358 -4 -11 4. Currò , V. (1997) Randomized controlled trial assessing the effectiveness of a booklet on the duration of breast feeding, Archives of Disease in Childhood 76: 500– 504 5. Perez-Escamilla R. (2007) Evidence Based Breast-Feeding Promotion: The Baby-Friendly Hospital Initiative, The Journal of Nutrition 137: 484– 487 6. Department of Health, Office of Vital Statistics, Florida Birth Certificate http: //www. floridacharts. com/charts/Birth. Query. aspx 23

Thank You… Questions? 24

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