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Completed

NCT Number: NCT01938118

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

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.

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Women's Health Research, University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obesity Prevention Group

Behavioral

Injury Prevention Group

Behavioral

Primary outcomes

  1. Mean weight-for-length z-score at 15 months of age

    Time frame: 15 months of age

    Anthropometrics measured directly in the home by trained study staff

Secondary outcomes

  1. Proportion of infants ever breastfed and exclusively breastfed at 3 and 6 months of age

    Time frame: 3 and 6 months of age

    Measured using an Infant Diet History questionnaire adapted after the Infant Feeding Practices Study II

  2. Proportion of infants fed complementary foods before 4 or 6 months of age

    Time frame: 4 and 6 months of age

    Measured using an Infant Diet History questionnaire adapted after the Infant Feeding Practices Study II

  3. 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

    Time frame: 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)

  4. 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

    Time frame: 3, 6, 9, 12 and 15 months of age

    Measured using the Brief Infant Sleep Questionnaire (BISQ)

  5. 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

    Time frame: 3, 6, 9, 12 and 15 months of age

Other outcomes

  1. Breastfeeding attitude score at 28 and 37 weeks gestation and at 1, 3, 6, 9 and 12 months of age

    Time frame: 28 and 37 weeks gestation and 1, 3, 6, 9 and 12 months of age

    Measured using the Iowa Infant Feeding Attitude Scale

  2. Breastfeeding self-efficacy score at 1, 3, 6, 9 and 12 months

    Time frame: 1, 3, 6, 9 and 12 months of age

    Measured using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)

  3. Social support from family score at 1, 3, 6, 9 and 12 months of age

    Time frame: 1, 3, 6, 9 and 12 months of age

    Measured using the Perceived Social Support from Family Scale

  4. Responsive feeding style score at 28 and 37 weeks gestation and 1, 3, 6, 9, 12 and 15 months of age

    Time frame: 28 and 37 weeks gestation and at 1, 3, 6, 9, 12 and 15 months of age

    Measured using the Infant Feeding Styles Questionnaire (IFSQ) (belief items only at 28 and 37 weeks gestation, full scale at all other time points) and the Responsiveness to Child Feeding Cues Scale (RCFCS)at 3, 9 and 15 months.

  5. Perception of infant fussiness (i.e. IBQ-R 'Distress to Limitations' score and 'Activity' score) at 3, 6, 9 and 12 months of age

    Time frame: 3, 6, 9 and 12 months of age

    Measured using the Infant Behavior Questionnaire-Revised (IBQ-R)

  6. Change in weight-for-length z-score between birth to 15 months

    Time frame: Birth to 15 months

    Anthropometrics measured directly in the home by trained study staff

  7. Proportion of infants that are overweight, defined as weight-for-length z-score ≥ 95th percentile, at 15 months

    Time frame: 15 months of age

    Anthropometrics measured directly in the home by trained study staff

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 10, 2013
Registry last updated
Apr 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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