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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

Tracking Information
First Submitted Date  ICMJE March 26, 2012
First Posted Date  ICMJE March 28, 2012
Last Update Posted Date March 28, 2012
Study Start Date  ICMJE June 2005
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticipatory Guidance to Prevent Childhood Obesity
Official Title  ICMJE Can Changing How Moms Eat Prevent Obesity in Toddlers?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Childhood Obesity
Intervention  ICMJE
  • 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
  • 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"
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Maternal focused intervention
  • 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.
    Intervention: Behavioral: Ounce of Prevention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2012)
306
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01565525
Other Study ID Numbers  ICMJE HD50944
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Judith Groner, Nationwide Children's Hospital
Study Sponsor  ICMJE Nationwide Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Judith Groner, MD Nationwide Children's Hospital, Columbus Ohio
PRS Account Nationwide Children's Hospital
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP