Mealtime Interactions and Risk of Toddler Obesity

Sponsor
Temple University (Other)
Overall Status
Completed
CT.gov ID
NCT02766218
Collaborator
The Miriam Hospital (Other), California Polytechnic State University-San Luis Obispo (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
173
33

Study Details

Study Description

Brief Summary

The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with mother-toddler dyads who participated in a study that is testing the effects of a multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain in obese women. Specifically, dyads will be invited to participate in home-based assessments to videotape an evening meal, have anthropometric measures taken, and complete study questionnaires. The overall goal is to understand factors related prospectively to responsive feeding between mothers and toddlers at 18 months; determine whether responsive feeding at 18 and 24 months predicts change in zBMI and adiposity from 18-36 months; and explore which factors are most strongly predictive of child zBMI change from birth to 36 months.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    173 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Mealtime Interactions and Risk of Obesity in Toddlers
    Study Start Date :
    Sep 1, 2016
    Actual Primary Completion Date :
    Aug 1, 2018
    Actual Study Completion Date :
    Jun 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Behavioral: Lifestyle Intervention

    The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.

    No Intervention: Standard Care

    Outcome Measures

    Primary Outcome Measures

    1. Responsive feeding [18- and 24-months]

      The Responsiveness to Child Feeding Cues Scale will be used to code maternal responsive feeding. Primary outcomes are: a) maternal responsiveness to toddler fullness cues.

    Secondary Outcome Measures

    1. Child Weight Status [birth, 6-, 12-, 18-, 24- and 36-months]

      zBMI will be computed at each time point

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Months to 36 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Mother participated in clinical trial #NCT01545934

    • Child 18-36 months old

    Exclusion Criteria:
    • Child chronic health conditions that could affect feeding or growth (diagnosed feeding disorders, use of feeding tube) or could influence the mealtime interaction (significant food allergies or dietary restrictions, diagnosed psychiatric disorders, or pervasive developmental delays).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Temple University
    • The Miriam Hospital
    • California Polytechnic State University-San Luis Obispo
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Chantelle Hart, PhD, Temple University
    • Principal Investigator: Suzanne Phelan, PhD, California Polytechnic State University-San Luis Obispo
    • Principal Investigator: Rena Wing, PhD, The Miriam Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Temple University
    ClinicalTrials.gov Identifier:
    NCT02766218
    Other Study ID Numbers:
    • 23356
    • R01DK108661
    • R56DK108661
    First Posted:
    May 9, 2016
    Last Update Posted:
    Feb 4, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Temple University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 4, 2021