Anticipatory Guidance to Prevent Childhood Obesity

NCT ID: NCT01565525

Last Updated: 2012-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-07-31

Brief Summary

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The purpose of this pilot project is to test anticipatory guidance, which is information given to families during a well child visit to prevent obesity during childhood. The objectives were to compare two styles of anticipatory guidance during the first year of life, maternal focused and infant focused, versus usual care and determine which style, if any, showed the most ideal infant feeding behaviors at age 1 year and to see if there were any differences in infant weight for height at one year of age. The investigators hypothesized that mothers who received the maternal focused anticipatory guidance (which gave information on eating family meals, not having tv on during meals, and maternal nutrition) would actually have the best infant feeding behaviors and weight for height of infants at one year.

Detailed Description

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Conditions

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Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Bright Futures

This represents 'usual care' in the pediatric office. The anticipatory guidance regarding nutrition is based on the Bright Futures Pocket Guide.

Group Type NO_INTERVENTION

No interventions assigned to this group

Maternal focused intervention

Childhood obesity prevention was approached in this arm via anticipatory guidance aimed at maternal eating habits.

Group Type EXPERIMENTAL

Maternal focused intervention

Intervention Type BEHAVIORAL

This is a series of information given to mothers at child's well child visits (6 in all) starting at the newborn visit focused in maternal eating habits, using the mother as a potential 'agent of change' for the family and infant in modeling healthy eating habits.

Ounce of Prevention

This is a program of anticipatory guidance given to mothers of infants ages 2 weeks to one year which focuses on serving size per age and tips for introducing new foods for the infant.

Group Type ACTIVE_COMPARATOR

Ounce of Prevention

Intervention Type BEHAVIORAL

This intervention is given via a series of handouts given to mothers at their child's well visit from newborn period to one year of age, focusing on serving size and frequency and the introduction of new foods.

Interventions

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Maternal focused intervention

This is a series of information given to mothers at child's well child visits (6 in all) starting at the newborn visit focused in maternal eating habits, using the mother as a potential 'agent of change' for the family and infant in modeling healthy eating habits.

Intervention Type BEHAVIORAL

Ounce of Prevention

This intervention is given via a series of handouts given to mothers at their child's well visit from newborn period to one year of age, focusing on serving size and frequency and the introduction of new foods.

Intervention Type BEHAVIORAL

Other Intervention Names

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MOMS "Ounce"

Eligibility Criteria

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Inclusion Criteria

Maternal/infant pairs Infant under 2 months of age Mother English speaking

Exclusion Criteria

History of Neonatal ICU stay in infant Gestation less than 37 weeks in infant chronic disease in infant known genetic disorder in infant foster care placement in infant
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Judith Groner

Clinical Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith Groner, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital, Columbus Ohio

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Groner JA, Skybo T, Murray-Johnson L, Schwirian P, Eneli I, Sternstein A, Klein E, French G. Anticipatory guidance for prevention of childhood obesity: design of the MOMS project. Clin Pediatr (Phila). 2009 Jun;48(5):483-92. doi: 10.1177/0009922809331799. Epub 2009 Feb 25.

Reference Type BACKGROUND
PMID: 19246415 (View on PubMed)

Nicholson LM, Schwirian PM, Klein EG, Skybo T, Murray-Johnson L, Eneli I, Boettner B, French GM, Groner JA. Recruitment and retention strategies in longitudinal clinical studies with low-income populations. Contemp Clin Trials. 2011 May;32(3):353-62. doi: 10.1016/j.cct.2011.01.007. Epub 2011 Jan 27.

Reference Type BACKGROUND
PMID: 21276876 (View on PubMed)

French GM, Nicholson L, Skybo T, Klein EG, Schwirian PM, Murray-Johnson L, Sternstein A, Eneli I, Boettner B, Groner JA. An evaluation of mother-centered anticipatory guidance to reduce obesogenic infant feeding behaviors. Pediatrics. 2012 Sep;130(3):e507-17. doi: 10.1542/peds.2011-3027. Epub 2012 Aug 13.

Reference Type DERIVED
PMID: 22891225 (View on PubMed)

Other Identifiers

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HD50944

Identifier Type: -

Identifier Source: org_study_id

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