InfantINSIGHTNCT01167270
The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study
A study testing Child Safety Insights and Parenting Insights in people with Infant and Obesity, run by Ian M. Paul, MD at 2 sites in United States.
Trial summary
This study will test an intervention program designed to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle to see if that intervention will prevent rapid weight gain in infancy and overweight at age 3 years. Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- What is being tested?
- Child Safety Insights and Parenting Insights
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to 31 Dec 2023
- 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 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- full-term infant(> 37 0/7 weeks gestational age)discharged from hospital without significant morbidity
- singleton infant
- nursery/NICU/maternity stay of 7 days or less
- primiparous mother
- English speaking mother
Who cannot join
- presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease
- any major maternal morbidities and/or pre-existing condition that would affect postpartum care such as cancer, multiple sclerosis, lupus, etc.
- maternal age <=20 years
- prenatal ultrasound presence of intrauterine growth retardation (IUGR)
- infant birth weight <2500 grams plan for newborn to be adopted
- plan to move from Central Pennsylvania within 3 years
- inability to complete contact form with name, address, phone numbers, etc.
- Practicing pediatrician or pediatric resident
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Penn State University
State College, Pennsylvania, 16802
About this study
This study will test an intervention program designed to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle to see if that intervention will prevent rapid weight gain in infancy and overweight at age 3 years. Further, compared with control infants, intervention infants will have lower body mass index (BMI) percentiles at age 3. The investigators also hypothesize that control infants will gain weight more rapidly over time.
Read the detailed description
Principal Hypotheses: An intervention program designed to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle will prevent rapid weight gain in infancy and overweight at age 3 years. Further, compared with control infants, intervention infants will have lower BMI percentiles at age 3. We also hypothesize that control infants will gain weight more rapidly over time, adjusting for trait-stable and time-varying covariates (e.g., maternal pre-pregnancy BMI, percent of feedings that are breast milk vs. formula, sleep duration, and feeding frequency).
The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study, will test these hypotheses in a two arm randomized trial where participants in a program to prevent childhood obesity will be compared with those in a child safety control program. Nurses will deliver interventions to first-time parents and their infants in both study groups at four home visits in the first year after birth followed by annual clinical research center visits until age 3. Blood samples for genetic testing on appetite, growth, and temperament will be collected from mother, child, and father. The obesity prevention program focuses on messages of responsive parenting and healthy lifestyle, extending from infancy through age 3 years. The intervention will teach first-time parents to interact with their infants in a way that is prompt, emotionally supportive, contingent, and developmentally appropriate. This information is especially important during the first year after birth as infants make a dramatic dietary transition from the initial exclusive milk diet to one with many foods of the adult diet of their culture. During this transition, as foods are being introduced to children, there are numerous opportunities to address dietary content as well as parent feeding style. In addition to these messages, intervention parents will be given education on growth charts, the meaning of growth chart percentiles, and healthy growth patterns during early life. The intervention program is hypothesized to show efficacy in both breast and formula fed infants as measured by the primary outcome, body mass index (BMI) percentile at age 3 years. Additionally, participants will be followed to collect anthropometric measurements at 4,5,6,10,14,and 17 years of age to provide significant insight into long-term obesity risk.
The proposed research adds two major pieces by enrolling second born siblings and collecting genetic specimens from both siblings and their parents. Specifically, this translational research will a) prospectively evaluate obesity-related parenting similarities and differences as well as weight-related outcomes between first and second-born siblings, b) explore how genetic differences among siblings that are associated with appetite, temperament, and obesity susceptibility affect parent-child interactions, degree of responsive parenting, and weight status, and c) determine whether INSIGHT study intervention carryover effects occur among families participating in the observation-only second-born child evaluation.
- Being tested
- Child Safety Insights, Parenting Insights
- Keywords
- Infant Diet, Toddler Diet, Responsive Feeding, Infant Temperament, Parent competency, Childhood Obesity prevention, Rapid infant weight gain
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child Safety InsightsBehavioural
A child safety intervention with messages focused on the infant's environment and interactions with parents. They will be guided by the American Academy of Pediatrics as well as the Academy's guide for health supervision, Bright Futures.
Parenting InsightsBehavioural
Educational program contains messages to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle that will prevent rapid weight gain in infancy and overweight at age 3 years.
| Study group | Role | What they receive |
|---|---|---|
| Parenting Insight | Active comparator | Educational program contains messages to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle that will prevent rapid weight gain in infancy and overweight at age 3 years. Receives: Behavioral: Parenting Insights |
| Child Safety Insights | Placebo comparator | A child safety intervention with messages focused on the infant's environment and interactions with parents. They will be guided by the AAP guidelines and the Academy's guide for health supervision, Bright Futures Receives: Behavioral: Child Safety Insights |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI percentile at 3 years
BMI percentile at 3 years
Measured: 3 years
Secondary outcomes (4)
Weight-for-length percentile at several intervals in the first 12 months after birth
Weight-for-length percentile at several intervals in the first 12 months after birth
Measured: 12 months of age
BMI percentile at age 2 years
BMI percentile at age 2 years
Measured: 2 years of age
Proportion of infants with BMI > 85th and 95th percentiles at ages 2 and 3 years
Proportion of infants with BMI > 85th and 95th percentiles at ages 2 and 3
Measured: aged 2 and 3 years
Proportion of infants with accelerated weight gain between numerous study intervals
Proportion of infants with accelerated weight gain between numerous study
Measured: birth to 4 months, birth to 1 year, birth to 3 years, 1 year to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJan 2012
- Primary completionApr 2017
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for InfantStudies 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
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ian M. Paul, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ian M. Paul, MD, Milton S. Hershey Medical Center
- Investigators
- Leann L Birch, PhD, Principal investigator, Penn State UniversityIan M Paul, MD, MSc, Principal investigator, Penn State College of Medicine and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167270
- Sponsor's protocol ID
- 34493
- Other IDs
- 1R01DK088244-01
- Acronym
- INSIGHT
- Status last verified
- Jan 2024
- First submitted
- 21 Jul 2010
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paul IM, Williams JS, Anzman-Frasca S, Beiler JS, Makova KD, Marini ME, Hess LB, Rzucidlo SE, Verdiglione N, Mindell JA, Birch LL. The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study. BMC Pediatr. 2014 Jul 18;14:184. doi: 10.1186/1471-2431-14-184.
PubMed 25037579Paul IM, Savage JS, Anzman-Frasca S, Marini ME, Mindell JA, Birch LL. INSIGHT Responsive Parenting Intervention and Infant Sleep. Pediatrics. 2016 Jul;138(1):e20160762. doi: 10.1542/peds.2016-0762.
PubMed 27354460Savage JS, Birch LL, Marini M, Anzman-Frasca S, Paul IM. Effect of the INSIGHT Responsive Parenting Intervention on Rapid Infant Weight Gain and Overweight Status at Age 1 Year: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):742-9. doi: 10.1001/jamapediatrics.2016.0445.
PubMed 27271455Paul IM, Hohman EE, Birch LL, Shelly A, Vallotton CD, Savage JS. Exploring infant signing to enhance responsive parenting: Findings from the INSIGHT study. Matern Child Nutr. 2019 Jul;15(3):e12800. doi: 10.1111/mcn.12800. Epub 2019 Mar 19.
PubMed 30810273Craig SJC, Blankenberg D, Parodi ACL, Paul IM, Birch LL, Savage JS, Marini ME, Stokes JL, Nekrutenko A, Reimherr M, Chiaromonte F, Makova KD. Child Weight Gain Trajectories Linked To Oral Microbiota Composition. Sci Rep. 2018 Sep 19;8(1):14030. doi: 10.1038/s41598-018-31866-9.
PubMed 30232389Eagleton SG, Hohman EE, Verdiglione N, Birch LL, Paul IM, Savage JS. INSIGHT Study Maternal Return to Work and Infant Weight Outcomes. Acad Pediatr. 2019 Jan-Feb;19(1):67-73. doi: 10.1016/j.acap.2018.08.008. Epub 2018 Aug 23.
PubMed 30145361Savage JS, Hohman EE, Marini ME, Shelly A, Paul IM, Birch LL. INSIGHT responsive parenting intervention and infant feeding practices: randomized clinical trial. Int J Behav Nutr Phys Act. 2018 Jul 9;15(1):64. doi: 10.1186/s12966-018-0700-6.
PubMed 29986721Paul IM, Savage JS, Anzman-Frasca S, Marini ME, Beiler JS, Hess LB, Loken E, Birch LL. Effect of a Responsive Parenting Educational Intervention on Childhood Weight Outcomes at 3 Years of Age: The INSIGHT Randomized Clinical Trial. JAMA. 2018 Aug 7;320(5):461-468. doi: 10.1001/jama.2018.9432.
PubMed 30088009Anzman-Frasca S, Paul IM, Moding KJ, Savage JS, Hohman EE, Birch LL. Effects of the INSIGHT Obesity Preventive Intervention on Reported and Observed Infant Temperament. J Dev Behav Pediatr. 2018 Dec;39(9):736-743. doi: 10.1097/DBP.0000000000000597.
PubMed 29927795Adams EL, Marini ME, Stokes J, Birch LL, Paul IM, Savage JS. INSIGHT responsive parenting intervention reduces infant's screen time and television exposure. Int J Behav Nutr Phys Act. 2018 Mar 15;15(1):24. doi: 10.1186/s12966-018-0657-5.
PubMed 29544506Hohman EE, Savage JS, Birch LL, Beiler JS, Paul IM. Pacifier Use and Early Life Weight Outcomes in the Intervention Nurses Start Infants Growing on Healthy Trajectories Study. Child Obes. 2018 Jan;14(1):58-66. doi: 10.1089/chi.2017.0177. Epub 2017 Oct 4.
PubMed 28976781Paul IM, Hohman EE, Loken E, Savage JS, Anzman-Frasca S, Carper P, Marini ME, Birch LL. Mother-Infant Room-Sharing and Sleep Outcomes in the INSIGHT Study. Pediatrics. 2017 Jul;140(1):e20170122. doi: 10.1542/peds.2017-0122. Epub 2017 Jun 5.
PubMed 28759407Carney MC, Tarasiuk A, DiAngelo SL, Silveyra P, Podany A, Birch LL, Paul IM, Kelleher S, Hicks SD. Metabolism-related microRNAs in maternal breast milk are influenced by premature delivery. Pediatr Res. 2017 Aug;82(2):226-236. doi: 10.1038/pr.2017.54. Epub 2017 May 24.
PubMed 28422941Hohman EE, Paul IM, Birch LL, Savage JS. INSIGHT responsive parenting intervention is associated with healthier patterns of dietary exposures in infants. Obesity (Silver Spring). 2017 Jan;25(1):185-191. doi: 10.1002/oby.21705.
PubMed 28008749Dadzie A, Master L, Hohman EE, Acton EH, Tauriello S, Paul IM, Savage JS, Anzman-Frasca S, Buxton OM. Associations Between Sleep Health and Child Behavior at Age 6 Years in the INSIGHT Study. J Dev Behav Pediatr. 2025 Jan-Feb 01;46(1):e56-e63. doi: 10.1097/DBP.0000000000001326. Epub 2024 Nov 8.
PubMed 39514718
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study
- ClinicalTrials.gov ID
- NCT01167270
- Acronym / sponsor ID
- INSIGHT / 34493
- Keywords
- Infant Diet, Toddler Diet, Responsive Feeding, Infant Temperament, Parent competency, Childhood Obesity prevention, Rapid infant weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Ian M. Paul, MDUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2012
- Primary completion
- Apr 2017 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Jul 2010 (estimated)
- 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.
This study will test an intervention program designed to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle to see if that intervention will prevent rapid weight gain in infancy and overweight at age 3 years. Further, compared with control infants, intervention infants will have lower body mass index (BMI) percentiles at age 3. The investigators also hypothesize that control infants will gain weight more rapidly over time.
Detailed description
Principal Hypotheses: An intervention program designed to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle will prevent rapid weight gain in infancy and overweight at age 3 years. Further, compared with control infants, intervention infants will have lower BMI percentiles at age 3. We also hypothesize that control infants will gain weight more rapidly over time, adjusting for trait-stable and time-varying covariates (e.g., maternal pre-pregnancy BMI, percent of feedings that are breast milk vs. formula, sleep duration, and feeding frequency).
The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study, will test these hypotheses in a two arm randomized trial where participants in a program to prevent childhood obesity will be compared with those in a child safety control program. Nurses will deliver interventions to first-time parents and their infants in both study groups at four home visits in the first year after birth followed by annual clinical research center visits until age 3. Blood samples for genetic testing on appetite, growth, and temperament will be collected from mother, child, and father. The obesity prevention program focuses on messages of responsive parenting and healthy lifestyle, extending from infancy through age 3 years. The intervention will teach first-time parents to interact with their infants in a way that is prompt, emotionally supportive, contingent, and developmentally appropriate. This information is especially important during the first year after birth as infants make a dramatic dietary transition from the initial exclusive milk diet to one with many foods of the adult diet of their culture. During this transition, as foods are being introduced to children, there are numerous opportunities to address dietary content as well as parent feeding style. In addition to these messages, intervention parents will be given education on growth charts, the meaning of growth chart percentiles, and healthy growth patterns during early life. The intervention program is hypothesized to show efficacy in both breast and formula fed infants as measured by the primary outcome, body mass index (BMI) percentile at age 3 years. Additionally, participants will be followed to collect anthropometric measurements at 4,5,6,10,14,and 17 years of age to provide significant insight into long-term obesity risk.
The proposed research adds two major pieces by enrolling second born siblings and collecting genetic specimens from both siblings and their parents. Specifically, this translational research will a) prospectively evaluate obesity-related parenting similarities and differences as well as weight-related outcomes between first and second-born siblings, b) explore how genetic differences among siblings that are associated with appetite, temperament, and obesity susceptibility affect parent-child interactions, degree of responsive parenting, and weight status, and c) determine whether INSIGHT study intervention carryover effects occur among families participating in the observation-only second-born child evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenting Insight | Active comparator | Behavioral: Parenting InsightsEducational program contains messages to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle that will prevent rapid weight gain in infancy and overweight at age 3 years. |
| Child Safety Insights | Placebo comparator | Behavioral: Child Safety InsightsA child safety intervention with messages focused on the infant's environment and interactions with parents. They will be guided by the AAP guidelines and the Academy's guide for health supervision, Bright Futures |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- full-term infant(> 37 0/7 weeks gestational age)discharged from hospital without significant morbidity
- singleton infant
- nursery/NICU/maternity stay of 7 days or less
- primiparous mother
- English speaking mother
Key exclusion criteria (8 listed)
- presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease
- any major maternal morbidities and/or pre-existing condition that would affect postpartum care such as cancer, multiple sclerosis, lupus, etc.
- maternal age <=20 years
- prenatal ultrasound presence of intrauterine growth retardation (IUGR)
- infant birth weight <2500 grams 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 |
|---|---|---|
| Child Safety InsightsA child safety intervention with messages focused on the infant's environment and interactions with parents. They will be guided by the American Academy of Pediatrics as well as the Academy's guide for health supervision, Bright Futures. | Behavioural | Child Safety Insights |
| Parenting InsightsEducational program contains messages to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle that will prevent rapid weight gain in infancy and overweight at age 3 years. | Behavioural | Parenting Insight |
Primary outcome
BMI percentile at 3 years
Time frame: 3 years
BMI percentile at 3 years
4 secondary outcomes
Weight-for-length percentile at several intervals in the first 12 months after birth
Time frame: 12 months of age
BMI percentile at age 2 years
Time frame: 2 years of age
Proportion of infants with BMI > 85th and 95th percentiles at ages 2 and 3 years
Time frame: aged 2 and 3 years
Proportion of infants with accelerated weight gain between numerous study intervals
Time frame: birth to 4 months, birth to 1 year, birth to 3 years, 1 year to 3 years
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 31 Jan 2024.
- Background: PubMed 25037579Paul IM, Williams JS, Anzman-Frasca S, Beiler JS, Makova KD, Marini ME, Hess LB, Rzucidlo SE, Verdiglione N, Mindell JA, Birch LL. The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study. BMC Pediatr. 2014 Jul 18;14:184. doi: 10.1186/1471-2431-14-184.
- Results publication: PubMed 27354460Paul IM, Savage JS, Anzman-Frasca S, Marini ME, Mindell JA, Birch LL. INSIGHT Responsive Parenting Intervention and Infant Sleep. Pediatrics. 2016 Jul;138(1):e20160762. doi: 10.1542/peds.2016-0762.
- Results publication: PubMed 27271455Savage JS, Birch LL, Marini M, Anzman-Frasca S, Paul IM. Effect of the INSIGHT Responsive Parenting Intervention on Rapid Infant Weight Gain and Overweight Status at Age 1 Year: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):742-9. doi: 10.1001/jamapediatrics.2016.0445.
- Results publication: PubMed 30810273Paul IM, Hohman EE, Birch LL, Shelly A, Vallotton CD, Savage JS. Exploring infant signing to enhance responsive parenting: Findings from the INSIGHT study. Matern Child Nutr. 2019 Jul;15(3):e12800. doi: 10.1111/mcn.12800. Epub 2019 Mar 19.
- Results publication: PubMed 30232389Craig SJC, Blankenberg D, Parodi ACL, Paul IM, Birch LL, Savage JS, Marini ME, Stokes JL, Nekrutenko A, Reimherr M, Chiaromonte F, Makova KD. Child Weight Gain Trajectories Linked To Oral Microbiota Composition. Sci Rep. 2018 Sep 19;8(1):14030. doi: 10.1038/s41598-018-31866-9.
- Results publication: PubMed 30145361Eagleton SG, Hohman EE, Verdiglione N, Birch LL, Paul IM, Savage JS. INSIGHT Study Maternal Return to Work and Infant Weight Outcomes. Acad Pediatr. 2019 Jan-Feb;19(1):67-73. doi: 10.1016/j.acap.2018.08.008. Epub 2018 Aug 23.
- Results publication: PubMed 29986721Savage JS, Hohman EE, Marini ME, Shelly A, Paul IM, Birch LL. INSIGHT responsive parenting intervention and infant feeding practices: randomized clinical trial. Int J Behav Nutr Phys Act. 2018 Jul 9;15(1):64. doi: 10.1186/s12966-018-0700-6.
- Results publication: PubMed 30088009Paul IM, Savage JS, Anzman-Frasca S, Marini ME, Beiler JS, Hess LB, Loken E, Birch LL. Effect of a Responsive Parenting Educational Intervention on Childhood Weight Outcomes at 3 Years of Age: The INSIGHT Randomized Clinical Trial. JAMA. 2018 Aug 7;320(5):461-468. doi: 10.1001/jama.2018.9432.
- Results publication: PubMed 29927795Anzman-Frasca S, Paul IM, Moding KJ, Savage JS, Hohman EE, Birch LL. Effects of the INSIGHT Obesity Preventive Intervention on Reported and Observed Infant Temperament. J Dev Behav Pediatr. 2018 Dec;39(9):736-743. doi: 10.1097/DBP.0000000000000597.
- Results publication: PubMed 29544506Adams EL, Marini ME, Stokes J, Birch LL, Paul IM, Savage JS. INSIGHT responsive parenting intervention reduces infant's screen time and television exposure. Int J Behav Nutr Phys Act. 2018 Mar 15;15(1):24. doi: 10.1186/s12966-018-0657-5.
- Results publication: PubMed 28976781Hohman EE, Savage JS, Birch LL, Beiler JS, Paul IM. Pacifier Use and Early Life Weight Outcomes in the Intervention Nurses Start Infants Growing on Healthy Trajectories Study. Child Obes. 2018 Jan;14(1):58-66. doi: 10.1089/chi.2017.0177. Epub 2017 Oct 4.
- Results publication: PubMed 28759407Paul IM, Hohman EE, Loken E, Savage JS, Anzman-Frasca S, Carper P, Marini ME, Birch LL. Mother-Infant Room-Sharing and Sleep Outcomes in the INSIGHT Study. Pediatrics. 2017 Jul;140(1):e20170122. doi: 10.1542/peds.2017-0122. Epub 2017 Jun 5.
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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.
Leann L Birch, PhD principal investigator
Penn State University
Ian M Paul, MD, MSc principal investigator
Penn State College of Medicine and Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child Safety Insights and Parenting Insights in people with Infant and Obesity, run by Ian M. Paul, MD at 2 sites 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 5 inclusion and 8 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 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
BMI percentile at 3 years (time frame: 3 years). 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 NCT01167270, which also lists 21 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 31 Jan 2024.