NCT01938118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

4.2 years

First QC Date

August 9, 2013

Last Update Submit

April 18, 2018

Conditions

Obesity

Keywords

Infant dietFamily dietResponsive feedingInfant temperamentPhysical activityTelevision

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

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

    3 and 6 months of age

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

    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

    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

    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

Other Outcomes (7)

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

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

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

    1, 3, 6, 9 and 12 months of age

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

    1, 3, 6, 9 and 12 months of age

  • +4 more other outcomes

Study Arms (2)

Obesity Prevention Group

EXPERIMENTAL

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

Injury Prevention Group

ACTIVE COMPARATOR

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

Interventions

Obesity Prevention GroupBEHAVIORAL
Obesity Prevention Group
Injury Prevention GroupBEHAVIORAL
Injury Prevention Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

  • 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.

    PMID: 32811460DERIVED

  • 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.

    PMID: 28600160DERIVED

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Margaret E Bentley, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Heather Wasser, PhD

    University of North Carolina, Chapel Hill

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2013

First Posted

September 10, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations

US(1)