Sleep-Safe: A Strong African American Families Study
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/25/2018 |
| Start Date: | March 4, 2018 |
| End Date: | July 31, 2021 |
| Contact: | Leann L Birch, PhD |
| Email: | llb15@uga.edu |
| Phone: | 706-542-2899 |
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.
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.
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 infant weight and reducing rapid weight gain from birth 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.
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 infant weight and reducing rapid weight gain from birth 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.
Inclusion Criteria:
1. full-term infant (> 36 0/7 weeks gestational age), apparently healthy and without
significant morbidity
2. singleton infant
3. nursery/NICU/maternity stay of 7 days or less
4. Mother at least 18 years of age
5. Mother self-identifies as African American
6. Mother is primiparous
Exclusion Criteria:
1. non-English speaking
2. infant birth weight <2500 grams
3. 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)
4. 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).
5. plan for newborn to be adopted
6. plan to move from area within four months of delivery
7. residence further than 75 miles from Augusta, GA
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