Mothers and CareGivers Investing in Children

NCT ID: NCT04177472

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-14

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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. Children from minority groups may be disproportionately affected, such that Hispanic and non-Hispanic Black children have greater weight for recumbent length compared to White children. Similarly, socioeconomic status (SES) may affect child weight status. Epidemiological evidence indicates that obesity may transmitted across multiple generations. Genetics are a factor in determining weight status, but parents are largely responsible for regulating children's dietary environments. Grandparents increasingly provide care for their grandchildren, yet few studies have examined grandparent involvement or the role that grandparents or other significant caregivers play in feeding the child.

The objective of the current study is two-fold: 1) to evaluate the extent to which mothers and other caregivers affect mothers' parenting surrounding feeding their infant, beginning when the infant is first introduced to solid foods; and 2) to examine whether an intervention aimed at providing both mothers and and other important caregivers with hands-on training regarding healthy foods and responsive and sensitive feeding behaviors improves mothers' and other caregivers' responsive and sensitive behaviors and infants' weight trajectories over time. The researchers will collect both self-report data on diet, child temperament, mothers and caregiver mental health, stress and support. Observational assessments will be obtained to code co-caregiver behavior and caregiver responsiveness during feeding.

Conditions

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Obesity, Childhood Parenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Obesity Prevention Group

Intervention Type BEHAVIORAL

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.

Infant Safety and Injury Prevention Group

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

Group Type ACTIVE_COMPARATOR

Infant Safety and Injury Prevention Group

Intervention Type BEHAVIORAL

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

Obesity Prevention Group + Food Boxes

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.

Group Type EXPERIMENTAL

Obesity Prevention Group + Food Boxes

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Obesity Prevention Group + Food Boxes

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.

Intervention Type BEHAVIORAL

Infant Safety and Injury Prevention Group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Babies with metabolic or feeding issues.
* Mothers younger than 16 years of age.
Minimum Eligible Age

0 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. David's Foundation

UNKNOWN

Sponsor Role collaborator

National Cattlemen's Beef Association

INDUSTRY

Sponsor Role collaborator

Egg Nutrition Center

OTHER

Sponsor Role collaborator

National Pork Board

OTHER

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Deborah Jacobvitz

Phyllis L. Richards Endowed Professor in Child Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deborah Jacobvitz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Elizabeth Widen, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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Sarah M. & Charles E. Seay Building

Austin, Texas, United States

Site Status

Dell Pediatric Research Institute

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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UT Austin IRB#2015040017

Identifier Type: -

Identifier Source: org_study_id

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