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

NCT ID: NCT01938118

Last Updated: 2018-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-12-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Injury Prevention Group

Intervention Type: BEHAVIORAL

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 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.

Group Type: EXPERIMENTAL

Obesity Prevention Group

Intervention Type: BEHAVIORAL

Interventions

Obesity Prevention Group

Intervention Type: BEHAVIORAL

Injury Prevention Group

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret E Bentley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Heather Wasser, PhD

Role: STUDY_DIRECTOR

University of North Carolina, Chapel Hill

Locations

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

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32811460 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28600160 (View on PubMed)

Other Identifiers

1R01HD073237-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-0510

Identifier Type: -

Identifier Source: org_study_id