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

University of North Carolina (UNC)

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Injury Prevention Group; Behavioral: Obesity Prevention Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01938118

1R01HD073237-01 (U.S. NIH Grant/Contract)

12-0510

Details and patient eligibility

About

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.

Full 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.

Enrollment: 430 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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430 participants in 2 patient groups

Obesity Prevention Group

Experimental group

Description:

Mothers and families receive a developmentally appropriate educational intervention designed to promote healthy lifestyle behaviors for prevention of excessive weight gain between birth to 15 months of life. Educational content is delivered through eight home visits, five newsletters and twice weekly text messages. At several time points the mother identifies another family member/caregiver to actively participate in the program with her.

Treatment:

Behavioral: Obesity Prevention Group

Injury Prevention Group

Active Comparator group

Description:

Mothers and families receive a developmentally appropriate educational intervention designed to promote automobile and home safety behaviors for prevention of childhood injury. Educational content is delivered through eight home visits, five newsletters and twice weekly text messages. At several time points the mother identifies another family member/caregiver, who is only asked to complete surveys/assessments.

Treatment:

Behavioral: Injury Prevention Group