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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04177472
Other study ID # StDavids2017
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 14, 2019
Est. completion date August 31, 2023

Study information

Verified date November 2019
Source University of Texas at Austin
Contact Deborah Jacobvitz, PhD
Phone 512-232-5879
Email debj@austin.utexas.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 grandmothers or other important caregivers affect their mothers' parenting surrounding feeding their child, and 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.


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 grandmothers and/or 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 grandmothers or other important caregivers with hands-on training regarding healthy foods and responsive feeding behaviors improves mothers' and grandmothers' feeding behaviors and infants' weight trajectories over time. The researchers will collect both self-report data on diet, child temperament, mothers and other caregivers' mental health, stress and support. Observational assessments will be obtained to code co-caregiver behavior and caregiver responsiveness during feeding.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 90 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Dell Pediatric Research Institute Austin Texas
United States Sarah M. & Charles E. Seay Building Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Infant dietary intake of fruits and vegetables, animal source foods, whole grains, desserts and sweets, and salty snacks at 11 months of age Measured at 10-11 months using an Infant Diet History questionnaire adapted from the Infant Feeding Practices Study II. Measured at 10 to 11 months using the Nutrition Data System for Research (NDSR) 10 to 11 months of age
Other Responsive feeding at 10 to 11 months of age Measured using the Infant Feeding Styles Questionnaire (IFSQ) full scale 10 to 11 months of age
Other Responsive feeding at 10 to 11 months of age Measured during mealtime observations using the Chatoor's feeding scale. 11 months of age
Primary BMI percentile at 12 months of age Anthropometrics measured by trained study staff 12 months
Secondary Proportion of infants with BMI percentile >85th at 12 months of age Anthropometrics measured by trained study staff 12 months
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