Sleep-Safe: A Strong African American Families Study

Weight Gain Clinical Trial

Official title:

Sleep-Safe: A Strong African American Families Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03505203
• Other study ID #: 20180320
• Secondary ID: R01DK112874
• Status: Completed
• Phase: N/A
• Start date: March 4, 2018
• Est. completion date: July 5, 2021

Study information

• Verified date: October 2022
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: July 5, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

1. Infant > 37 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 17 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

Related Conditions & MeSH terms

• Weight Gain

Intervention

Behavioral:
• Sleep Soothe
An intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness.
• Sleep Safe
An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe.

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
University of Georgia	Augusta University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Hernandez E, Lavner JA, Moore AM, Stansfield BK, Beach SRH, Smith JJ, Savage JS. Sleep SAAF responsive parenting intervention improves mothers' feeding practices: a randomized controlled trial among African American mother-infant dyads. Int J Behav Nutr P — View Citation

Lavner JA, Savage JS, Stansfield BK, Beach SRH, Marini ME, Smith JJ, Sperr MC, Anderson TN, Hernandez E, Moore AM, Caldwell AL, Birch LL. Effects of the Sleep SAAF responsive parenting intervention on rapid infant weight gain: A randomized clinical trial — View Citation

Lavner JA, Stansfield BK, Beach SRH, Brody GH, Birch LL. Sleep SAAF: a responsive parenting intervention to prevent excessive weight gain and obesity among African American infants. BMC Pediatr. 2019 Jul 5;19(1):224. doi: 10.1186/s12887-019-1583-7. — View Citation

Moore AM, Smith JJ, Stansfield BK, Savage JS, Lavner JA. Patterns and Predictors of Breast Milk Feeding from Birth to Age 4 Months among Primiparous African American Mother-Infant Dyads. Nutrients. 2022 Jun 4;14(11). pii: 2350. doi: 10.3390/nu14112350. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal report of infant sleep at 8 weeks	Sleep duration and number of night awakenings using the Brief Infant Sleep Questionnaire (Sadeh, 2004)	8 weeks
Other	Maternal report of infant sleep at 16 weeks	Sleep duration and number of night awakenings using the Brief Infant Sleep Questionnaire (Sadeh, 2004)	16 weeks
Other	Maternal sleep actigraphy	7-day actigraphy data to assess mothers' sleep duration	8 weeks postpartum
Other	Infant soothing at 8 weeks	Parents use feeding for reasons other than in response to hunger	8 weeks
Other	Infant soothing at 16 weeks	Parents use feeding for reasons other than in response to hunger	16 weeks
Other	Infant feeding frequency at 16 weeks	Feeding frequency, use of bottle feeding, and introduction of solids using Babies Need Feeding (Stifter et al., 2011)	16 weeks
Other	Safe sleep practices	Frequency of sleep safety practices (Fowler et al., 2013)	16 weeks
Other	Child safety practices	Child safety practices assessed using the Framingham Safety Survey (Hansen et al., 1996)	16 weeks
Other	Infant eating behavior	Infant eating behavior using the Baby Eating Behavior Questionnaire (Llewellyn et al., 2011)	16 weeks
Other	Parental self-efficacy at 8 weeks	Perceived parental self-efficacy at 8 weeks using total score from the Karitane Parenting Confidence Scale (Crncec, Barnett, & Matthey, 2008)	8 weeks
Other	Parental self-efficacy at 16 weeks	Perceived parental self-efficacy at 16 weeks using total score from the Karitane Parenting Confidence Scale (Crncec, Barnett, & Matthey, 2008)	16 weeks
Other	Maternal feeding practices and beliefs at 8 weeks	Maternal feeding beliefs and behaviors using the Infant Feeding Styles Questionnaire (Thompson et al., 2009)	8 weeks
Other	Maternal feeding practices and beliefs at 16 weeks	Maternal feeding beliefs and behaviors using the Infant Feeding Styles Questionnaire (Thompson et al., 2009)	16 weeks
Other	Maternal depressive symptoms at 8 weeks	Maternal depressive symptoms at 8 weeks using the CES-D (Radloff, 1977)	8 weeks
Other	Maternal depressive symptoms at 16 weeks	Maternal depressive symptoms at 16 weeks using the CES-D (Radloff, 1977)	16 weeks
Other	Family routines	Extent to which there is order and routine versus chaos and confusion in their home. Uses total score from the Confusion, Hubbub, and Order Scale (Matheny et al., 1995)	8 weeks
Primary	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	Change in infants' weight for age	Growth curve models of change in infants' weight for age	3 weeks to 16 weeks
Secondary	Weight-for-age z scores	Weight-for-age z scores at 16 weeks	16 weeks
Secondary	Weight-for-length z scores	Weight-for-length z scores at 16 weeks	16 weeks
Secondary	Infant BMI z scores	BMI z scores at 16 weeks	16 weeks