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Prevention of Overfeeding During Infancy

University of California (UC) Davis logo

University of California (UC) Davis

Status and phase

Completed
Phase 2

Conditions

Obesity

Treatments

Behavioral: Use of baby bottle nipple

Study type

Interventional

Funder types

Other

Identifiers

NCT01043978
200715679

Details and patient eligibility

About

The overall goal of this project is to identify strategies to prevent overfeeding during infancy. One objective is to evaluate the impact on intake of allowing the infant greater control over the amount consumed when feeding from a bottle. This will be accomplished via the use of a novel nipple that mimics (functionally) the nipple of a human breast and allows the infant to self-regulate milk flow. The second objective is to evaluate the relationship between parental feeding styles and infant intake.

Enrollment

231 patients

Sex

All

Ages

Under 3 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Infant born at > 37 weeks gestation
  • Infant weighed >2500 g at birth
  • Infant is apparently healthy
  • Mother speaks English
  • Mother is 18 years of age or older
  • Mother/infant pair lives within a 10-mile radius around the UC Davis Medical Center in Sacramento, CA
  • Mother plans to use a bottle (at least occasionally) to feed her infant before he/she is 3 months old.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

231 participants in 2 patient groups

Novel nipple
Experimental group
Treatment:
Behavioral: Use of baby bottle nipple
Coventional nipple
Active Comparator group
Treatment:
Behavioral: Use of baby bottle nipple

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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