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Sleep-Safe: A Strong African American Families Study

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ClinicalTrials.gov Identifier: NCT03505203
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Collaborators:
Augusta University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Leann Birch, University of Georgia

Brief 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.

Condition or disease Intervention/treatment Phase
Weight Gain Behavioral: Sleep Soothe Behavioral: Sleep Safe Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to one of two conditions: (1) Sleep Soothe, where parents are given information on how to respond to their baby's cues related to sleeping and fussiness, and (2) Sleep Safe, 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)
Primary Purpose: Prevention
Official Title: Sleep-Safe: A Strong African American Families Study
Actual Study Start Date : March 4, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


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.
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.

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
Behavioral: Sleep Safe
An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in infants' weight for age [ Time Frame: 3 weeks to 16 weeks ]
    Growth curve models of change in infants' weight for age

  2. Weight-for-age z scores [ Time Frame: 16 weeks ]
    Weight-for-age z scores at 16 weeks

  3. Weight-for-length z scores [ Time Frame: 16 weeks ]
    Weight-for-length z scores at 16 weeks

  4. Infant BMI z scores [ Time Frame: 16 weeks ]
    BMI z scores at 16 weeks


Other Outcome Measures:
  1. 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

  2. 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

  3. Maternal sleep actigraphy [ Time Frame: 8 weeks postpartum ]
    7-day actigraphy data to assess mothers' sleep duration

  4. Infant soothing at 8 weeks [ Time Frame: 8 weeks ]
    Parents use feeding for reasons other than in response to hunger

  5. Infant soothing at 16 weeks [ Time Frame: 16 weeks ]
    Parents use feeding for reasons other than in response to hunger

  6. Infant feeding frequency at 16 weeks [ Time Frame: 16 weeks ]
    Feeding frequency, use of bottle feeding, and introduction of solids using Babies Need Feeding

  7. Safe sleep practices [ Time Frame: 16 weeks ]
    Frequency of sleep safety practices (Fowler et al., 2013)

  8. Child safety practices [ Time Frame: 16 weeks ]
    Child safety practices assessed using the Framingham Safety Survey

  9. Infant eating behavior [ Time Frame: 16 weeks ]
    Infant eating behavior using the Baby Eating Behavior Questionnaire

  10. Parental self-efficacy at 8 weeks [ Time Frame: 8 weeks ]
    Perceived parental self-efficacy at 8 weeks using the Karitane Parenting Confidence Scale

  11. Parental self-efficacy at 16 weeks [ Time Frame: 16 weeks ]
    Perceived parental self-efficacy at 16 weeks using the Karitane Parenting Confidence Scale

  12. Maternal feeding practices and beliefs at 8 weeks [ Time Frame: 8 weeks ]
    Maternal feeding beliefs and behaviors using the Infant Feeding Styles Questionnaire

  13. Maternal feeding practices and beliefs at 16 weeks [ Time Frame: 16 weeks ]
    Maternal feeding beliefs and behaviors using the Infant Feeding Styles Questionnaire

  14. Maternal depressive symptoms at 8 weeks [ Time Frame: 8 weeks ]
    Maternal depressive symptoms at 8 weeks using the CES-D

  15. Maternal depressive symptoms at 16 weeks [ Time Frame: 16 weeks ]
    Maternal depressive symptoms at 16 weeks using the CES-D

  16. Family routines [ Time Frame: 8 weeks ]
    Extent to which there is order and routine versus chaos and confusion in their home



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505203


Contacts
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Contact: Leann L Birch, PhD 706-542-2899 llb15@uga.edu
Contact: Justin A Lavner, PhD 706-542-3033 lavner@uga.edu

Locations
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United States, Georgia
University of Georgia Recruiting
Athens, Georgia, United States, 30602
Contact: Leann Birch, PhD    706-542-2899    llb15@uga.edu   
Contact: Justin Lavner, PhD    706-542-3033    lavner@uga.edu   
Sponsors and Collaborators
University of Georgia
Augusta University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Leann L Birch, PhD University of Georgia
Principal Investigator: Justin A Lavner, PhD University of Georgia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leann Birch, William P. "Bill" Flatt Childhood Obesity Professor, University of Georgia
ClinicalTrials.gov Identifier: NCT03505203     History of Changes
Other Study ID Numbers: 20180320
R01DK112874 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms