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Anticipatory Guidance to Prevent Childhood Obesity (MOMS)

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ClinicalTrials.gov Identifier: NCT01565525
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : March 28, 2012
Sponsor:
Information provided by (Responsible Party):
Judith Groner, Nationwide Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Maternal focused intervention Behavioral: Ounce of Prevention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Can Changing How Moms Eat Prevent Obesity in Toddlers?
Study Start Date : June 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Arm Intervention/treatment
No Intervention: Bright Futures
This represents 'usual care' in the pediatric office. The anticipatory guidance regarding nutrition is based on the Bright Futures Pocket Guide.
Experimental: Maternal focused intervention
Childhood obesity prevention was approached in this arm via anticipatory guidance aimed at maternal eating habits.
Behavioral: 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.
Other Name: MOMS

Active Comparator: 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.
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.
Other Name: "Ounce"




Primary Outcome Measures :
  1. Infant weight for height [ Time Frame: One year after study entry ]
    Infant weight for height will be assessed to see if proportions of elevated weight for height are lower in intervention groups as compared to usual care.


Secondary Outcome Measures :
  1. Maternal feeding behaviors [ Time Frame: One year after study entry. ]
    Several maternal feeding behaviors, including amount of vegetables and fruit offered to infant, eating as a 'family', amount of television watching by the infant, and juice intake by the infant were secondary outcomes.



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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


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): NCT01565525


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Judith Groner, MD Nationwide Children's Hospital, Columbus Ohio
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Judith Groner, Clinical Professor of Pediatrics, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01565525    
Other Study ID Numbers: HD50944
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012
Keywords provided by Judith Groner, Nationwide Children's Hospital:
well child visit
anticipatory guidance
obesity prevention
infant feeding
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight