Mealtime Interactions and Risk of Toddler Obesity

NCT02766218 | Completed DMC

• 3 other identifiers: 23356R01DK108661R56DK108661
• Study Type: observational
• Target: 173
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

toddler obesity; responsive feeding; behavioral weight control; pregnancy weight gain; early life risk factors

Outcome Measures

Primary Outcomes (1)

• Responsive feeding

  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.

  18- and 24-months

Secondary Outcomes (1)

• Child Weight Status

  birth, 6-, 12-, 18-, 24- and 36-months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Mothers and their 18-month-old toddlers who participated in clinical trial #NCT01545934 will be invited to participate in this observational study.

You may qualify if:

• Mother participated in clinical trial #NCT01545934
• Child 18-36 months old

You may not qualify if:

• 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).

Sponsors & Collaborators

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

MeSH Terms

Conditions

Obesity; Gestational Weight Gain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: May 9, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: June 1, 2019
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share