Clinical trial NCT04177472: Mothers and CareGivers Investing in Children
Official title: MAGIC: a Family Based Feeding Intervention Program
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity, Childhood
Parenting
Keywords: nutrition
parenting
intergenerational feeding influences
sensitive feeding
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: St. David's Foundation
name: National Cattlemen's Beef Association
name: Egg Nutrition Center
name: National Pork Board
First posted: 2019-11-26
Enrollment: 165
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: BMI percentile at 12 months of age
timeFrame: 12 months
measure: BMI percentile at 24 months of age
timeFrame: 24 months
Secondary outcomes:
measure: Proportion of infants with BMI percentile >85th at 12 months of age
timeFrame: 12 months
measure: Proportion of infants with BMI percentile >85th at 24 months of age
timeFrame: 24 months
Other outcomes:
measure: Infant dietary intake of fruits and vegetables, animal source foods, whole grains, desserts and sweets, and salty snacks at 11 months of age
timeFrame: 10 to 11 months of age
measure: Responsive feeding at 10 to 11 months of age
timeFrame: 10 to 11 months of age
measure: Responsive feeding at 10 to 11 months of age
timeFrame: 11 months of age
Locations:
city: Austin
country: United States
facility: Sarah M. & Charles E. Seay Building
state: Texas
city: Austin
country: United States
facility: Dell Pediatric Research Institute
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Deborah Jacobvitz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Austin
name: Elizabeth Widen, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: