NCT04177472

Brief Summary

The incidence of childhood obesity in the United States has steadily increased over the past 30 years but has begun to level off in recent years. Epidemiological evidence indicates that obesity may transmitted across multiple generations. The current study seeks to: 1) evaluate the extent to which mothers and other important caregivers affect their mothers' parenting; 2) examine whether an intervention aimed at improving diet quality and enhancing responsive feeding to improves parental responsivity and feeding behavior and infants' weight trajectories over time; 3) examine the effects of early life feeding and caregiver sensitivity on health and development; and 4) examine feasibility of food distribution along with the feeding intervention.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Nov 2019Dec 2026

First Submitted

Initial submission to the registry

October 25, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

November 14, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 28, 2026

Status Verified

March 1, 2026

Enrollment Period

6.5 years

First QC Date

October 25, 2019

Last Update Submit

April 22, 2026

Conditions

Keywords

nutritionparentingintergenerational feeding influencessensitive feeding

Outcome Measures

Primary Outcomes (2)

  • BMI percentile at 12 months of age

    Anthropometrics measured by trained study staff

    12 months

  • BMI percentile at 24 months of age

    Anthropometrics measured by trained study staff

    24 months

Secondary Outcomes (2)

  • Proportion of infants with BMI percentile >85th at 12 months of age

    12 months

  • Proportion of infants with BMI percentile >85th at 24 months of age

    24 months

Other Outcomes (3)

  • Infant dietary intake of fruits and vegetables, animal source foods, whole grains, desserts and sweets, and salty snacks at 11 months of age

    10 to 11 months of age

  • Responsive feeding at 10 to 11 months of age

    10 to 11 months of age

  • Responsive feeding at 10 to 11 months of age

    11 months of age

Study Arms (3)

Obesity Prevention Group

EXPERIMENTAL

Parents will be provided with responsive feeding coaching to help them recognize hunger and satiety cues and nutrition coaching that involves recommending a sequence of introducing complementary foods that corresponds with food textures and feeding styles, breast/bottle weaning, healthy snacking and hands on demonstrations for healthy food options.

Behavioral: Obesity Prevention Group

Infant Safety and Injury Prevention Group

ACTIVE COMPARATOR

Parents will be provided with information about safe sleeping, car seats, baby-proofing, etc., delivered during virtual visits, participant binder and newsletter.

Behavioral: Infant Safety and Injury Prevention Group

Obesity Prevention Group + Food Boxes

EXPERIMENTAL

Parents will be provided with responsive feeding coaching to help them recognize hunger and satiety cues and nutrition coaching that involves recommending a sequence of introducing complementary foods that corresponds with food textures and feeding styles, breast/bottle weaning, healthy snacking and hands on demonstrations for healthy food options. Parents will also be provided with grocery items (fruits, vegetables, meat) prior to each intervention visit to facilitate a healthy family diet.

Behavioral: Obesity Prevention Group + Food Boxes

Interventions

Parents will be provided with responsive feeding coaching to help them recognize hunger and satiety cues and nutrition coaching that involves recommending a sequence of introducing complementary foods that corresponds with food textures and feeding styles, breast/bottle weaning, healthy snacking and hands on demonstrations for healthy food options.

Obesity Prevention Group

Parents will be provided with responsive feeding coaching to help them recognize hunger and satiety cues and nutrition coaching that involves recommending a sequence of introducing complementary foods that corresponds with food textures and feeding styles, breast/bottle weaning, healthy snacking and hands on demonstrations for healthy food options. Parents will also be provided with grocery items (fruits, vegetables, meat) prior to each intervention visit to facilitate a healthy family diet.

Obesity Prevention Group + Food Boxes

Parents will be provided with information about safe sleeping, car seats, baby-proofing, etc., delivered during home visits, newsletters, and reinforcing text messages.

Infant Safety and Injury Prevention Group

Eligibility Criteria

Age0 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers with babies aged 4 to 5 months
  • Other caregivers assisting the mother with the baby.
  • Babies aged 4 to 5 months

You may not qualify if:

  • Babies with metabolic or feeding issues.
  • Mothers younger than 16 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sarah M. & Charles E. Seay Building

Austin, Texas, 78712, United States

Location

Dell Pediatric Research Institute

Austin, Texas, 78723, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Deborah Jacobvitz, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR
  • Elizabeth Widen, PhD, RD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Primary - BMI percentile at 12 months of age, and 24 months of age Secondary- Proportion of infants with BMI percentile \>85th at 12 months of age, and 24 months of age Anthropometrics measured directly by trained study staff Infant dietary intake of fruits and vegetables, animal source foods, whole grains, desserts and sweets, and salty snacks at 10 to 11 months. Measured at 10 months using an Infant Diet History questionnaire adapted from the Infant Feeding Practices Study II. Measured at 10 months using the Nutrition Data System for Research (NDSR) Responsive feeding measured using the Infant Feeding Styles Questionnaire (IFSQ) full scale and Chatoor's feeding scale at 10 to 11 months.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phyllis L. Richards Endowed Professor in Child Development

Study Record Dates

First Submitted

October 25, 2019

First Posted

November 26, 2019

Study Start

November 14, 2019

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 28, 2026

Record last verified: 2026-03

Locations