Sleep-Safe: A Strong African American Families Study

Study Overview
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Brief Summary
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Rapid weight gain during infancy is a powerful, and potentially malleable, risk factor for later overweight and obesity, but limited research has examined the impact of promising interventions when applied to the groups most at risk for rapid weight gain in infancy. The present study examines whether providing mothers of newborns with responsive parenting guidance during the first weeks of life to promote infant sleep and soothing can reduce rapid weight gain for African American infants born in low SES contexts.

Detailed Description
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The study design is a randomized controlled trial. This trial will deliver a responsive parenting intervention (Sleep Soothe) to provide information on how to soothe, how to distinguish hunger from other distress, how to promote self-soothing, and bedtime routines. The responsive parenting intervention will be compared to a safety control group (Sleep Safe). The programs will be delivered across 2 sessions at 3-weeks and 8-weeks postpartum. Both interventions and all data collection will be delivered in participants' homes. Assessments will be conducted in participants' homes at 1-week postpartum, 3 weeks postpartum, 8 weeks postpartum, and 16-weeks postpartum. Three hundred African American infants and their mothers will be recruited from the mother/baby nursery at Augusta University Medical Center. A dedicated recruitment coordinator will have access to electronic medical records systems in order to pre-screen mothers and infants. The recruitment coordinator will approach those who match basic inclusion criteria and will deliver an approved verbal script to pre-screened mothers to determine interest in participation. Interested mothers will respond to remaining screening questions in order to confirm eligibility. Once enrollment criteria are satisfied, informed consent will be obtained from the infant's mother during her hospital stay. Mothers will also complete selected demographic information. Anthropometric measurements will be obtained on the infant, mother, and father (optional). After enrollment, families will be scheduled for a research visit at their home at 1 week postpartum. At home visit 1 (7-10 days postpartum), mothers (and fathers, if interested) will complete questionnaire measures using Qualtrics. There will also be measurements of infant weight and length. Families will be randomized to condition following this visit. At home visit 2 (3 weeks postpartum), families will receive either the responsive parenting intervention or the safety control intervention. They will complete brief questionnaires. Measures of infant, maternal, and paternal (optional) weight will be obtained. At home visit 3 (8 weeks postpartum), families will receive either the second part of the responsive parenting intervention or the second part of the safety control intervention. They will complete brief questionnaires. Measures of infant, maternal, and (optional: paternal) weight will be obtained. Mothers will be provided with activity monitors for themselves and for their babies that will be picked up by study staff after 7 days' use. At home visit 4 (16 weeks postpartum), mothers will complete questionnaire measures (fathers' participation is optional). Measures of maternal and paternal (optional) weight will be obtained, as will measures of infant weight, length, and head circumference. We test the following specific aims: Specific Aim 1: To assess the effects of responsive parenting, focused on infant sleep and soothing, on reducing rapid weight gain from 3 to 16 weeks among African American infants. We hypothesize that infants in the Sleep Soothe condition will gain weight more slowly compared to infants in the Sleep Safe condition and have lower weight outcomes (i.e., BMI z scores, weight-for-length z scores, weight-for-age z scores) at age 16 weeks. Specific Aim 2: To assess effects of responsive parenting on parental and infant behaviors. We hypothesize that compared with parents in the Sleep Safe condition, parents in the Sleep Soothe condition will show increases in responsive parenting, parenting self-efficacy, and the use of alternatives to feeding to soothe (white noise, pacifier, etc.), and decreases in feeding to soothe. Over time, infants in this condition will have longer sleep bouts and fewer feedings. Specific Aim 3: To examine moderation of intervention effects by individual and contextual factors.

Official Title
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Sleep-Safe: A Strong African American Families Study

Conditions
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Weight Gain

Intervention / Treatment
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* Behavioral: Sleep Soothe
* Behavioral: Sleep Safe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant > 37 0/7 weeks gestational age, apparently healthy and without significant morbidity Singleton infant Nursery/NICU/maternity stay of 7 days or less Mother at least 17 years of age Mother self-identifies as African American Mother is primiparous Exclusion Criteria: Non-English speaking Infant birth weight <2500 grams Presence of a congenital anomaly or neonatal physical or metabolic condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease) Any major maternal morbidities, pre-existing condition that would affect postpartum care or her ability to care for her newborn (e.g., narcotic drug use: heroin, cocaine, meth, pain pills, etc; on chemotherapy; uncontrolled MS; uncontrolled depression causing social service contact). Plan for newborn to be adopted Plan to move from area within four months of delivery Residence further than 75 miles from Augusta, GA

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

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
Interventional Model Description: Participants will be assigned to one of two conditions: (1) Sleep Soothe (responsive parenting), where parents are given information on how to respond to their baby's cues related to sleeping and fussiness, and (2) Sleep Safe (safety control), where parents are given information on a safe sleep environment, as well as other strategies they can use to keep their baby safe.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep Soothe<br>An intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness. | Behavioral: Sleep Soothe<br>* An intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness.<br>|
| Active Comparator: Sleep Safe<br>An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe | Behavioral: Sleep Safe<br>* An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in infants' weight for age from 3 weeks to 16 weeks (conditional weight gain) | Standardized residuals from the linear regression of weight for age at 16 weeks on weight for age at 3 weeks, with length for age at birth and 16 weeks and infant age at the 16-week assessment entered as covariates | 3 weeks to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in infants' weight for age | Growth curve models of change in infants' weight for age | 3 weeks to 16 weeks | 
| Weight-for-age z scores | Weight-for-age z scores at 16 weeks | 16 weeks | 
| Weight-for-length z scores | Weight-for-length z scores at 16 weeks | 16 weeks | 
| Infant BMI z scores | BMI z scores at 16 weeks | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Responsive parenting, Mother-child relations, Infant feeding, Infant sleeping, Infant obesity