- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03505203
Sleep-Safe: A Strong African American Families Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30602
- University of Georgia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleep Soothe
An intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness.
|
An intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness.
|
Active Comparator: Sleep Safe
An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe
|
An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in infants' weight for age from 3 weeks to 16 weeks (conditional weight gain)
Time Frame: 3 weeks to 16 weeks
|
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
Time Frame: 3 weeks to 16 weeks
|
Growth curve models of change in infants' weight for age
|
3 weeks to 16 weeks
|
Weight-for-age z scores
Time Frame: 16 weeks
|
Weight-for-age z scores at 16 weeks
|
16 weeks
|
Weight-for-length z scores
Time Frame: 16 weeks
|
Weight-for-length z scores at 16 weeks
|
16 weeks
|
Infant BMI z scores
Time Frame: 16 weeks
|
BMI z scores at 16 weeks
|
16 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal report of infant sleep at 8 weeks
Time Frame: 8 weeks
|
Sleep duration and number of night awakenings using the Brief Infant Sleep Questionnaire (Sadeh, 2004)
|
8 weeks
|
Maternal report of infant sleep at 16 weeks
Time Frame: 16 weeks
|
Sleep duration and number of night awakenings using the Brief Infant Sleep Questionnaire (Sadeh, 2004)
|
16 weeks
|
Maternal sleep actigraphy
Time Frame: 8 weeks postpartum
|
7-day actigraphy data to assess mothers' sleep duration
|
8 weeks postpartum
|
Infant soothing at 8 weeks
Time Frame: 8 weeks
|
Parents use feeding for reasons other than in response to hunger
|
8 weeks
|
Infant soothing at 16 weeks
Time Frame: 16 weeks
|
Parents use feeding for reasons other than in response to hunger
|
16 weeks
|
Infant feeding frequency at 16 weeks
Time Frame: 16 weeks
|
Feeding frequency, use of bottle feeding, and introduction of solids using Babies Need Feeding (Stifter et al., 2011)
|
16 weeks
|
Safe sleep practices
Time Frame: 16 weeks
|
Frequency of sleep safety practices (Fowler et al., 2013)
|
16 weeks
|
Child safety practices
Time Frame: 16 weeks
|
Child safety practices assessed using the Framingham Safety Survey (Hansen et al., 1996)
|
16 weeks
|
Infant eating behavior
Time Frame: 16 weeks
|
Infant eating behavior using the Baby Eating Behavior Questionnaire (Llewellyn et al., 2011)
|
16 weeks
|
Parental self-efficacy at 8 weeks
Time Frame: 8 weeks
|
Perceived parental self-efficacy at 8 weeks using total score from the Karitane Parenting Confidence Scale (Crncec, Barnett, & Matthey, 2008)
|
8 weeks
|
Parental self-efficacy at 16 weeks
Time Frame: 16 weeks
|
Perceived parental self-efficacy at 16 weeks using total score from the Karitane Parenting Confidence Scale (Crncec, Barnett, & Matthey, 2008)
|
16 weeks
|
Maternal feeding practices and beliefs at 8 weeks
Time Frame: 8 weeks
|
Maternal feeding beliefs and behaviors using the Infant Feeding Styles Questionnaire (Thompson et al., 2009)
|
8 weeks
|
Maternal feeding practices and beliefs at 16 weeks
Time Frame: 16 weeks
|
Maternal feeding beliefs and behaviors using the Infant Feeding Styles Questionnaire (Thompson et al., 2009)
|
16 weeks
|
Maternal depressive symptoms at 8 weeks
Time Frame: 8 weeks
|
Maternal depressive symptoms at 8 weeks using the CES-D (Radloff, 1977)
|
8 weeks
|
Maternal depressive symptoms at 16 weeks
Time Frame: 16 weeks
|
Maternal depressive symptoms at 16 weeks using the CES-D (Radloff, 1977)
|
16 weeks
|
Family routines
Time Frame: 8 weeks
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Justin A Lavner, Ph.D., University of Georgia
Publications and helpful links
General Publications
- 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):2350. doi: 10.3390/nu14112350.
- 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.
- 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 of African American families. Appetite. 2022 May 13;175:106080. doi: 10.1016/j.appet.2022.106080. Online ahead of print.
- 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 Phys Act. 2022 Oct 1;19(1):129. doi: 10.1186/s12966-022-01366-1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20180320
- R01DK112874 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Weight Gain
-
Andalas UniversityNational Institute of Health Research and Development, Ministry of Health...CompletedBirth Weight | Pregnancy Weight GainIndonesia
-
Western University, CanadaIowa State UniversityCompletedBirth Weight | Excessive Weight Gain in Pregnancy With Baby Delivered | Excessive Weight Gain in Pregnancy, First TrimesterCanada
-
University of PittsburghThe Obesity Society; Weight Watchers InternationalCompletedObesity | Weight Gain, Maternal | Postpartum Weight RetentionUnited States
-
Medical University of South CarolinaNational Center for Research Resources (NCRR)Terminated
-
T.C. ORDU ÜNİVERSİTESİEge UniversityCompletedGestational Weight GainTurkey
-
University of HawaiiCompletedGestational Weight GainUnited States
-
Helena PiccininiNova Scotia Health AuthorityWithdrawnGestational Weight GainCanada
-
West China HospitalWest China Second University HospitalCompleted
-
Corcept TherapeuticsEli Lilly and CompanyCompletedWeight-Gain PreventionIndia
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
Clinical Trials on Sleep Soothe
-
Southern California College of Optometry at Marshall...AllerganCompletedDry Eye SyndromeUnited States
-
University of California, IrvineApplied VRRecruitingPain | Patient SatisfactionUnited States
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)RecruitingSleep | Obesity, Childhood | Binge Eating | Self-regulationUnited States
-
Mats LekanderStockholm UniversityCompleted
-
University of CopenhagenCompleted
-
Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Tufts Medical CenterCompletedDry Eye DiseaseUnited States