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ObesityNCT01938118

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

A study testing Obesity Prevention Group and Injury Prevention Group in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Obesity Prevention Group and Injury Prevention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
430 participants
Where
1 siteUnited States
Study dates
Oct 2013to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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.

Read the 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
Being tested
Obesity Prevention Group, Injury Prevention Group
Keywords
Infant diet, Family diet, Responsive feeding, Infant temperament, Physical activity, Television
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Obesity Prevention GroupBehavioural

  • Injury Prevention GroupBehavioural

Study groups in NCT01938118
Study groupRoleWhat they receive
Obesity Prevention GroupExperimentalMothers 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.
Receives: Behavioral: Obesity Prevention Group
Injury Prevention GroupActive comparatorMothers 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.
Receives: Behavioral: Injury Prevention Group

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Anthropometrics measured directly in the home by trained study staff

    Measured: 15 months of age

Secondary outcomes (5)

  1. 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

    Measured: 3 and 6 months of age

  2. 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

    Measured: 4 and 6 months of age

  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

    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)

    Measured: 3, 6, 9, 12 and 15 months of age

  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

    Measured using the Brief Infant Sleep Questionnaire (BISQ)

    Measured: 3, 6, 9, 12 and 15 months of age

  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

    Measured: 3, 6, 9, 12 and 15 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
430 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01938118
Sponsor's protocol ID
12-0510
Other IDs
1R01HD073237-01
Status last verified
Apr 2018
First submitted
9 Aug 2013
Last updated
19 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32811460

  • 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.

    PubMed 28600160

Questions about this trial

What is this clinical trial studying?

A study testing Obesity Prevention Group and Injury Prevention Group in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean weight-for-length z-score at 15 months of age (time frame: 15 months of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01938118, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.

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