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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Obesity Prevention Group
* Behavioral: Injury Prevention Group


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obesity Prevention Group<br>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. | Behavioral: Obesity Prevention Group<br> <br> |
| Active Comparator: Injury Prevention Group<br>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. | Behavioral: Injury Prevention Group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean weight-for-length z-score at 15 months of age | Anthropometrics measured directly in the home by trained study staff | 15 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of infants ever breastfed and exclusively breastfed at 3 and 6 months of age | Measured using an Infant Diet History questionnaire adapted after the Infant Feeding Practices Study II | 3 and 6 months of age | 
| Proportion of infants fed complementary foods before 4 or 6 months of age | Measured using an Infant Diet History questionnaire adapted after the Infant Feeding Practices Study II | 4 and 6 months of age | 
| 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 | 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) | 3, 6, 9, 12 and 15 months of age | 
| 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 | Measured using the Brief Infant Sleep Questionnaire (BISQ) | 3, 6, 9, 12 and 15 months of age | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant diet, Family diet, Responsive feeding, Infant temperament, Physical activity, Television