Clinical trial NCT01938118: Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers
Official title: Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Infant diet
Family diet
Responsive feeding
Infant temperament
Physical activity
Television
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-09-10
Enrollment: 430
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean weight-for-length z-score at 15 months of age
timeFrame: 15 months of age
Secondary outcomes:
measure: Proportion of infants ever breastfed and exclusively breastfed at 3 and 6 months of age
timeFrame: 3 and 6 months of age
measure: Proportion of infants fed complementary foods before 4 or 6 months of age
timeFrame: 4 and 6 months of age
measure: 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
timeFrame: 3, 6, 9, 12 and 15 months of age
measure: 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
timeFrame: 3, 6, 9, 12 and 15 months of age
measure: 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
timeFrame: 3, 6, 9, 12 and 15 months of age
Other outcomes:
measure: Breastfeeding attitude score at 28 and 37 weeks gestation and at 1, 3, 6, 9 and 12 months of age
timeFrame: 28 and 37 weeks gestation and 1, 3, 6, 9 and 12 months of age
measure: Breastfeeding self-efficacy score at 1, 3, 6, 9 and 12 months
timeFrame: 1, 3, 6, 9 and 12 months of age
measure: Social support from family score at 1, 3, 6, 9 and 12 months of age
timeFrame: 1, 3, 6, 9 and 12 months of age
measure: Responsive feeding style score at 28 and 37 weeks gestation and 1, 3, 6, 9, 12 and 15 months of age
timeFrame: 28 and 37 weeks gestation and at 1, 3, 6, 9, 12 and 15 months of age
measure: Perception of infant fussiness (i.e. IBQ-R 'Distress to Limitations' score and 'Activity' score) at 3, 6, 9 and 12 months of age
timeFrame: 3, 6, 9 and 12 months of age
measure: Change in weight-for-length z-score between birth to 15 months
timeFrame: Birth to 15 months
measure: Proportion of infants that are overweight, defined as weight-for-length z-score ≥ 95th percentile, at 15 months
timeFrame: 15 months of age
Locations:
city: Chapel Hill
country: United States
facility: Center for Women's Health Research, University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Margaret E Bentley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Heather Wasser, PhD
role: STUDY_DIRECTOR
References:
citation: Wasser HM, Thompson AL, Suchindran CM, Goldman BD, Hodges EA, Heinig MJ, Bentley ME. Home-based intervention for non-Hispanic black families finds no significant difference in infant size or growth: results from the Mothers & Others randomized controlled trial. BMC Pediatr. 2020 Aug 18;20(1):385. doi: 10.1186/s12887-020-02273-9.
citation: Wasser HM, Thompson AL, Suchindran CM, Hodges EA, Goldman BD, Perrin EM, Faith MS, Bulik CM, Heinig MJ, Bentley ME. Family-based obesity prevention for infants: Design of the "Mothers & Others" randomized trial. Contemp Clin Trials. 2017 Sep;60:24-33. doi: 10.1016/j.cct.2017.06.002. Epub 2017 Jun 21.