Trial record 2 of 12 for:    toddler nutrition | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01938118
First received: August 9, 2013
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Obesity Prevention Group
Behavioral: Injury Prevention Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Mothers and Others: Family-based Obesity Prevention for Infants and Toddlers

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Mean weight-for-length z-score at 18 months of age [ Time Frame: 18 months of age ] [ Designated as safety issue: No ]
    Anthropometrics measured directly in the home by trained study staff


Secondary Outcome Measures:
  • Proportion of infants ever breastfed and exclusively breastfed at 3 and 6 months of age [ Time Frame: 3 and 6 months of age ] [ Designated as safety issue: No ]
    Measured using an Infant Diet History questionnaire adapted after the Infant Feeding Practices Study II

  • Proportion of infants fed complementary foods before 4 or 6 months of age [ Time Frame: 4 and 6 months of age ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3, 6, 9, 12 and 18 months of age ] [ Designated as safety issue: No ]
    Measured at 3, 6, 9 and 12 months using an Infant Diet History questionnaire adapted after the Infant Feeding Practices Study II. Measured at 18 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 [ Time Frame: 3, 6, 9, 12 and 18 months of age ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3, 6, 9, 12 and 18 months of age ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Measured using the Iowa Infant Feeding Attitude Scale

  • Breastfeeding self-efficacy score at 1, 3, 6, 9 and 12 months [ Time Frame: 1, 3, 6, 9 and 12 months of age ] [ Designated as safety issue: No ]
    Measured using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)

  • 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 ] [ Designated as safety issue: No ]
    Measured using the Perceived Social Support from Family Scale

  • Responsive feeding style score at 28 and 37 weeks gestation and 1, 3, 6, 9, 12 and 18 months of age [ Time Frame: 28 and 37 weeks gestation and at 1, 3, 6, 9, 12 and 18 months of age ] [ Designated as safety issue: No ]
    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 18 months.

  • 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 ] [ Designated as safety issue: No ]
    Measured using the Infant Behavior Questionnaire-Revised (IBQ-R)

  • Change in weight-for-length z-score between birth to 18 months [ Time Frame: Birth to 18 months ] [ Designated as safety issue: No ]
    Anthropometrics measured directly in the home by trained study staff

  • Proportion of infants that are overweight, defined as weight-for-length z-score ≥ 95th percentile, at 18 months [ Time Frame: 18 months of age ] [ Designated as safety issue: No ]
    Anthropometrics measured directly in the home by trained study staff


Estimated Enrollment: 468
Study Start Date: October 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obesity Prevention Group
Mothers and families receive a developmentally appropriate educational intervention designed to promote healthy lifestyle behaviors for prevention of excessive weight gain between birth to 18 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
Active Comparator: Injury Prevention Group
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

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 18 months, mean change in WLZ between 0-18 months, and likelihood of overweight (WLZ ≥ 95th percentile) at 18 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 least 18 years
  • Lives within specified distance of study site
  • Not intending to leave study area before expectant child's 18th month of life
  • Agreeable to referring another family member/caregiver to participate in the study

Exclusion Criteria:

  • Pre-term birth (<= 37 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938118

Contacts
Contact: Heather Wasser, PhD 919-843-4788 wasser@email.unc.edu
Contact: Kenitra Williams, MSW 919-843-1277 carbyshi@email.unc.edu

Locations
United States, North Carolina
Center for Women's Health Research, University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Heather Wasser, PhD    919-843-4788    wasser@email.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Margaret E Bentley, PhD University of North Carolina, Chapel Hill
Study Director: Heather Wasser, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01938118     History of Changes
Other Study ID Numbers: 12-0510, 1R01HD073237-01
Study First Received: August 9, 2013
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Infant diet
Family diet
Responsive feeding
Infant temperament
Physical activity
Television

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014