Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-28 @ 9:23 AM
Study NCT ID:
NCT03505203
Status:
COMPLETED
Last Update Posted:
2025-02-06
First Post:
2018-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep-Safe: a Strong African American Families Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2018-04-03', 'studyFirstSubmitQcDate': '2018-04-12', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maternal report of infant sleep at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Sleep duration and number of night awakenings using the Brief Infant Sleep Questionnaire (Sadeh, 2004)'}, {'measure': 'Maternal report of infant sleep at 16 weeks', 'timeFrame': '16 weeks', 'description': 'Sleep duration and number of night awakenings using the Brief Infant Sleep Questionnaire (Sadeh, 2004)'}, {'measure': 'Maternal sleep actigraphy', 'timeFrame': '8 weeks postpartum', 'description': "7-day actigraphy data to assess mothers' sleep duration"}, {'measure': 'Infant soothing at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Parents use feeding for reasons other than in response to hunger'}, {'measure': 'Infant soothing at 16 weeks', 'timeFrame': '16 weeks', 'description': 'Parents use feeding for reasons other than in response to hunger'}, {'measure': 'Infant feeding frequency at 16 weeks', 'timeFrame': '16 weeks', 'description': 'Feeding frequency, use of bottle feeding, and introduction of solids using Babies Need Feeding (Stifter et al., 2011)'}, {'measure': 'Safe sleep practices', 'timeFrame': '16 weeks', 'description': 'Frequency of sleep safety practices (Fowler et al., 2013)'}, {'measure': 'Child safety practices', 'timeFrame': '16 weeks', 'description': 'Child safety practices assessed using the Framingham Safety Survey (Hansen et al., 1996)'}, {'measure': 'Infant eating behavior', 'timeFrame': '16 weeks', 'description': 'Infant eating behavior using the Baby Eating Behavior Questionnaire (Llewellyn et al., 2011)'}, {'measure': 'Parental self-efficacy at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Perceived parental self-efficacy at 8 weeks using total score from the Karitane Parenting Confidence Scale (Crncec, Barnett, \\& Matthey, 2008)'}, {'measure': 'Parental self-efficacy at 16 weeks', 'timeFrame': '16 weeks', 'description': 'Perceived parental self-efficacy at 16 weeks using total score from the Karitane Parenting Confidence Scale (Crncec, Barnett, \\& Matthey, 2008)'}, {'measure': 'Maternal feeding practices and beliefs at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Maternal feeding beliefs and behaviors using the Infant Feeding Styles Questionnaire (Thompson et al., 2009)'}, {'measure': 'Maternal feeding practices and beliefs at 16 weeks', 'timeFrame': '16 weeks', 'description': 'Maternal feeding beliefs and behaviors using the Infant Feeding Styles Questionnaire (Thompson et al., 2009)'}, {'measure': 'Maternal depressive symptoms at 8 weeks', 'timeFrame': '8 weeks', 'description': 'Maternal depressive symptoms at 8 weeks using the CES-D (Radloff, 1977)'}, {'measure': 'Maternal depressive symptoms at 16 weeks', 'timeFrame': '16 weeks', 'description': 'Maternal depressive symptoms at 16 weeks using the CES-D (Radloff, 1977)'}, {'measure': 'Family routines', 'timeFrame': '8 weeks', 'description': '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)'}], 'primaryOutcomes': [{'measure': "Change in infants' weight for age from 3 weeks to 16 weeks (conditional weight gain)", 'timeFrame': '3 weeks to 16 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': "Change in infants' weight for age", 'timeFrame': '3 weeks to 16 weeks', 'description': "Growth curve models of change in infants' weight for age"}, {'measure': 'Weight-for-age z scores', 'timeFrame': '16 weeks', 'description': 'Weight-for-age z scores at 16 weeks'}, {'measure': 'Weight-for-length z scores', 'timeFrame': '16 weeks', 'description': 'Weight-for-length z scores at 16 weeks'}, {'measure': 'Infant BMI z scores', 'timeFrame': '16 weeks', 'description': 'BMI z scores at 16 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Responsive parenting', 'Mother-child relations', 'Infant feeding', 'Infant sleeping', 'Infant obesity'], 'conditions': ['Weight Gain']}, 'referencesModule': {'references': [{'pmid': '37000448', 'type': 'BACKGROUND', 'citation': 'Lavner JA, Hohman EE, Beach SRH, Stansfield BK, Savage JS. Effects of a Responsive Parenting Intervention Among Black Families on Infant Sleep: A Secondary Analysis of the Sleep SAAF Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1;6(3):e236276. doi: 10.1001/jamanetworkopen.2023.6276.'}, {'pmid': '37148966', 'type': 'BACKGROUND', 'citation': 'Hohman EE, Savage JS, Stansfield BK, Lavner JA. Sleep SAAF Responsive Parenting Intervention for Black Mothers Impacts Response to Infant Crying: A Randomized Clinical Trial. Acad Pediatr. 2024 Jan-Feb;24(1):97-104. doi: 10.1016/j.acap.2023.04.012. Epub 2023 May 5.'}, {'pmid': '38330306', 'type': 'BACKGROUND', 'citation': "Hart AR, Beach SRH, Hart CN, Smith JJ, Stansfield BK, Lavner JA. Responsive parenting and Black mothers' postpartum sleep: Secondary analysis of a randomized controlled trial. Health Psychol. 2024 Jun;43(6):438-447. doi: 10.1037/hea0001363. Epub 2024 Feb 8."}, {'pmid': '38548477', 'type': 'BACKGROUND', 'citation': 'Weber DM, Bryant CM, Williamson HC, Mussa K, Lavner JA. Predictors of change in relationship satisfaction among Black postpartum mothers. Fam Process. 2024 Jun;63(2):768-787. doi: 10.1111/famp.12990. Epub 2024 Mar 28.'}, {'pmid': '38884990', 'type': 'BACKGROUND', 'citation': 'Weber DM, Williamson HC, Bryant CM, Mussa KS, Lavner JA. Patterns and predictors of change in relationship status among Black mothers over 16 weeks postpartum. J Fam Psychol. 2024 Aug;38(5):751-762. doi: 10.1037/fam0001238. Epub 2024 Jun 17.'}, {'pmid': '39715425', 'type': 'BACKGROUND', 'citation': "Adesogan O, Beach SRH, Carter SE, Metzger IW, Lavner JA. Effects of a responsive parenting intervention on Black mothers' depressive symptoms postpartum: Secondary analysis of a randomized clinical trial. J Consult Clin Psychol. 2024 Dec;92(12):828-835. doi: 10.1037/ccp0000926."}, {'pmid': '35684150', 'type': 'BACKGROUND', '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):2350. doi: 10.3390/nu14112350.'}, {'pmid': '35577176', 'type': 'BACKGROUND', '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 of African American families. Appetite. 2022 Aug 1;175:106080. doi: 10.1016/j.appet.2022.106080. Epub 2022 May 13.'}, {'pmid': '36183135', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '31277694', 'type': 'BACKGROUND', '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.'}, {'pmid': '40036969', 'type': 'DERIVED', 'citation': "Hart AR, Beach SRH, Hart CN, Metzger IW, Lavner JA. Effects of contextual stress on Black mothers' self-reported and actigraph-estimated postpartum sleep. Sleep. 2025 Jul 11;48(7):zsaf023. doi: 10.1093/sleep/zsaf023."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThree 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.\n\nAt 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.\n\nAt 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.\n\nAt 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.\n\nAt 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.\n\nWe test the following specific aims:\n\nSpecific 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.\n\nSpecific 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.\n\nSpecific Aim 3: To examine moderation of intervention effects by individual and contextual factors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Infant \\> 37 0/7 weeks gestational age, apparently healthy and without significant morbidity\n2. Singleton infant\n3. Nursery/NICU/maternity stay of 7 days or less\n4. Mother at least 17 years of age\n5. Mother self-identifies as African American\n6. Mother is primiparous\n\nExclusion Criteria:\n\n1. Non-English speaking\n2. Infant birth weight \\<2500 grams\n3. 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)\n4. 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).\n5. Plan for newborn to be adopted\n6. Plan to move from area within four months of delivery\n7. Residence further than 75 miles from Augusta, GA"}, 'identificationModule': {'nctId': 'NCT03505203', 'briefTitle': 'Sleep-Safe: a Strong African American Families Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Georgia'}, 'officialTitle': 'Sleep-Safe: a Strong African American Families Study', 'orgStudyIdInfo': {'id': '20180320'}, 'secondaryIdInfos': [{'id': 'R01DK112874', 'link': 'https://reporter.nih.gov/quickSearch/R01DK112874', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep Soothe', 'description': "An intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness.", 'interventionNames': ['Behavioral: Sleep Soothe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sleep Safe', 'description': 'An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe', 'interventionNames': ['Behavioral: Sleep Safe']}], 'interventions': [{'name': 'Sleep Soothe', 'type': 'BEHAVIORAL', 'description': "An intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness.", 'armGroupLabels': ['Sleep Soothe']}, {'name': 'Sleep Safe', 'type': 'BEHAVIORAL', 'description': 'An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe.', 'armGroupLabels': ['Sleep Safe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30602', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'University of Georgia', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}], 'overallOfficials': [{'name': 'Justin A Lavner, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Georgia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Georgia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Augusta University', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Justin Lavner', 'investigatorAffiliation': 'University of Georgia'}}}}