Weight GainNCT03505203
Sleep-Safe: A Strong African American Families Study
A study testing Sleep Soothe and Sleep Safe in people with Weight Gain, run by University of Georgia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- Sleep Soothe and Sleep Safe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2018to 5 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Weight Gain
- Being tested
- Sleep Soothe, Sleep Safe
- Keywords
- Responsive parenting, Mother-child relations, Infant feeding, Infant sleeping, Infant obesity
- Medical subject headings
- Weight Gain, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep SootheBehavioural
An intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness.
Sleep SafeBehavioural
An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Soothe | Experimental | An intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness. Receives: Behavioral: Sleep Soothe |
| Sleep Safe | Active comparator | An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe Receives: Behavioral: Sleep Safe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 weeks to 16 weeks
Secondary outcomes (4)
Change in infants' weight for age
Growth curve models of change in infants' weight for age
Measured: 3 weeks to 16 weeks
Weight-for-age z scores
Weight-for-age z scores at 16 weeks
Measured: 16 weeks
Weight-for-length z scores
Weight-for-length z scores at 16 weeks
Measured: 16 weeks
Infant BMI z scores
BMI z scores at 16 weeks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start4 Mar 2018
- Primary completion5 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Augusta University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Justin Lavner, University of Georgia
- Investigators
- Justin A Lavner, Ph.D., Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505203
- Sponsor's protocol ID
- 20180320
- Other IDs
- R01DK112874
- Status last verified
- Oct 2022
- First submitted
- 3 Apr 2018
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31277694Lavner 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.
PubMed 37000448Hohman 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.
PubMed 37148966Hart 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.
PubMed 38330306Weber 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.
PubMed 38548477Weber 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.
PubMed 38884990Adesogan 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.
PubMed 39715425Moore 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.
PubMed 35684150Lavner 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.
PubMed 35577176Hernandez 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.
PubMed 36183135Hart 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.
PubMed 40036969
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep-Safe: A Strong African American Families Study
- ClinicalTrials.gov ID
- NCT03505203
- Acronym / sponsor ID
- 20180320
- Conditions
- Weight Gain
- Keywords
- Responsive parenting, Mother-child relations, Infant feeding, Infant sleeping, Infant obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- Augusta University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Mar 2018 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sleep Soothe | Experimental | Behavioral: Sleep SootheAn intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness. |
| Sleep Safe | Active comparator | Behavioral: Sleep SafeAn intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep SootheAn intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness. | Behavioural | Sleep Soothe |
| Sleep SafeAn intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe. | Behavioural | Sleep Safe |
Primary outcome
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
4 secondary outcomes
Change in infants' weight for age
Time frame: 3 weeks to 16 weeks
Weight-for-age z scores
Time frame: 16 weeks
Weight-for-length z scores
Time frame: 16 weeks
Infant BMI z scores
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 31277694Lavner 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.
- Results publication: PubMed 37000448Lavner 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.
- Results publication: PubMed 37148966Hohman 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.
- Results publication: PubMed 38330306Hart 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.
- Results publication: PubMed 38548477Weber 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.
- Results publication: PubMed 38884990Weber 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.
- Results publication: PubMed 39715425Adesogan 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.
- Results publication: PubMed 35684150Moore 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.
- Results publication: PubMed 35577176Lavner 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.
- Results publication: PubMed 36183135Hernandez 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.
- Derived from this study: PubMed 40036969Hart 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin A Lavner, Ph.D. principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Soothe and Sleep Safe in people with Weight Gain, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in infants' weight for age from 3 weeks to 16 weeks (conditional weight gain) (time frame: 3 weeks to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03505203, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.