Early Child Care and Risk of Obesity | NCT01788644

Studies
Early Child Care and Risk of Obesity

NCT01788644

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Oct 4, 2018Actual

Enrollment

860Actual

Phase

Not provided

Conditions

Child Adiposity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013Actual

Primary Completion Date

Sep 2016Actual

Completion Date

Jun 2018Actual

First Submitted Date

Feb 7, 2013

First Submission Date that Met QC Criteria

Feb 8, 2013

First Posted Date

Feb 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2018

Last Update Posted Date

Oct 4, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to examine risk factors associated with infant growth and the development of obesity in the first year of life. The investigators plan to establish a racially and ethnically diverse southern cohort of 800 mother/infant dyads, followed regularly from birth to 12 months of age. The cohort will be residents of Durham, North Carolina (NC) and the immediate surrounding area. The proposed longitudinal study will examine factors contributing to the development of obesity, including dietary behaviors, physical activity and inactivity, stress, and sleep duration and quality. Frequent in-home assessments throughout infancy and contact with other care providers will help pinpoint exactly when children begin to gain weight excessively and will identify risk factors related to energy intake, energy expenditure, stress, and sleep associated with obesity.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

860Actual

Label	Type	Description	Intervention Names
No treatment (observational study)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in child adiposity	In-person assessments of infant weight, length, and skinfold thicknesses at birth, 3, 6, 9, and 12 months of age	birth - 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mother over 18
in 2nd or 3rd trimester of pregnancy with singleton
speak and read English
planning to stay in area for the first year of baby's life

Exclusion Criteria:

baby born with conditions that may affect weight, feeding or motor activity

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Mothers/infant dyads in the Durham, NC area

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University Medical Center		Durham	North Carolina	27705	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28179416	Result	Benjamin Neelon SE, Ostbye T, Bennett GG, Kravitz RM, Clancy SM, Stroo M, Iversen E, Hoyo C. Cohort profile for the Nurture Observational Study examining associations of multiple caregivers on infant growth in the Southeastern USA. BMJ Open. 2017 Feb 8;7(2):e013939. doi: 10.1136/bmjopen-2016-013939.
28845369	Result

ID	Term
D009043	Motor Activity
D005247	Feeding Behavior

ID	Term
D001519	Behavior
D001522	Behavior, Animal