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Clinical Trials/NCT04177472
NCT04177472
Active, not recruiting
Not Applicable

MAGIC: A Family Based Feeding Intervention Program

University of Texas at Austin4 sites in 1 country165 target enrollmentNovember 14, 2019

Overview

Phase
Not Applicable
Intervention
Obesity Prevention Group
Conditions
Obesity, Childhood
Sponsor
University of Texas at Austin
Enrollment
165
Locations
4
Primary Endpoint
BMI percentile at 12 months of age
Status
Active, not recruiting
Last Updated
4 days ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 14, 2019
End Date
December 31, 2026
Last Updated
4 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deborah Jacobvitz

Phyllis L. Richards Endowed Professor in Child Development

University of Texas at Austin

Eligibility Criteria

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.

Arms & Interventions

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: Obesity Prevention Group

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.

Intervention: Infant Safety and Injury Prevention Group

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: Obesity Prevention Group + Food Boxes

Outcomes

Primary Outcomes

BMI percentile at 12 months of age

Time Frame: 12 months

Anthropometrics measured by trained study staff

BMI percentile at 24 months of age

Time Frame: 24 months

Anthropometrics measured by trained study staff

Secondary Outcomes

  • 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)

Study Sites (4)

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