Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT01938118
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The purpose of this study is to conduct a randomized controlled trial among 468 Non-Hispanic black mothers and their families to test the efficacy of MOTHERS AND OTHERS, a multi-component home visitation program, compared to an attention control (child safety) in promoting appropriate weight gain during infancy.

Detailed Description

Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers will be one of the first to meet the unique needs of individual families by delivering anticipatory guidance on infant care, feeding and growth through multiple channels and to multiple caregivers. Primary modes of delivery for the Obesity Prevention Group (experimental arm) will include face-to-face counseling through 8 home visits (1 by a certified Lactation Consultant), 5 health newsletters, and approximately 160 cue-based text messages. The Injury Prevention Group (active comparator) will receive messages on child safety delivered through similar channels. Our main outcome is infant/toddler growth, captured by mean weight-for-length z-scores (WLZ) at 15 months, mean change in WLZ between 0-15 months, and likelihood of overweight (WLZ ≥ 95th percentile) at 15 months. Differences between groups are expected to be achieved through uptake of targeted health behaviors, including a greater likelihood of breastfeeding initiation, exclusivity and duration; after 6 months, higher dietary intakes of whole fruits and vegetables and lower intakes of energy-dense snack foods; age-appropriate durations of infant and toddler sleep; and, lower levels of television and electronic media exposure. We further hypothesize that these targeted health behaviors will be achieved through modifiable risk factors underpinning the intervention, namely more positive breastfeeding attitudes; higher levels of parenting and breastfeeding self-efficacy; higher levels of perceived social support; higher responsive feeding style scores; improved accuracy in perceiving infant/toddler weight status; and, diminished parental perceptions of infant fussiness.

Study Timeline

• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Study Start: 2013-10
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

Inclusion Criteria

• Self identifies as non-Hispanic, African-American
• Less than 28 weeks pregnant at time of screening and recruitment
• Expecting a singleton birth
• Maternal age at time of birth will be at 18-39 years
• Lives within specified distance of study site
• Not intending to leave study area before expectant child's 15th month of life
• Agreeable to referring another family member/caregiver to participate in the study

Exclusion Criteria

• Pre-term birth (<= 36 weeks gestation)
• Less than 18 years at time of delivery
• Delivers infant with a congenital anomaly or medical condition that significantly affects feeding (e.g., cleft lip and/or palate, metabolic disease)
• Delivers multiples
• Newborn nursery, neonatal intensive care unit (NICU), or maternity floor stay for 7 or more days after the delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean weight-for-length z-score at 15 months of age	15 months of age	Anthropometrics measured directly in the home by trained study staff

Secondary Outcome Measures

Name	Time	Method
Proportion of infants ever breastfed and exclusively breastfed at 3 and 6 months of age	3 and 6 months of age	Measured using an Infant Diet History questionnaire adapted after the Infant Feeding Practices Study II
Infant dietary intake of fruits and vegetables, whole grains, desserts and sweets, and salty snacks at 3, 6, 9, 12 and 18 months of age	3, 6, 9, 12 and 15 months of age	Measured at 3, 6, 9 and 12 months using an Infant Diet History questionnaire adapted after the Infant Feeding Practices Study II. Measured at 15 months using the Nutrition Data System for Research (NDSR)
Duration of infant sleep (hours of total daily sleep, hours of nocturnal sleep, and number of night awakenings) at 3, 6, 9, 12 and 18 months of age	3, 6, 9, 12 and 15 months of age	Measured using the Brief Infant Sleep Questionnaire (BISQ)
Infant exposure to television and electronic media (number of hours of screen time per day, proportion of infants with a T.V. or other media screen in bedroom) at 3, 6, 9, 12 and 18 months of age	3, 6, 9, 12 and 15 months of age
Proportion of infants fed complementary foods before 4 or 6 months of age	4 and 6 months of age	Measured using an Infant Diet History questionnaire adapted after the Infant Feeding Practices Study II

Trial Locations

Locations (1)

Center for Women's Health Research, University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States