search
Back to results

Mothers And careGivers Investing in Children (MAGIC)

Primary Purpose

Obesity, Childhood, Parenting

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Obesity Prevention Group
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood focused on measuring nutrition, parenting, intergenerational feeding influences, sensitive feeding

Eligibility Criteria

undefined - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sarah M. & Charles E. Seay BuildingRecruiting
  • Dell Pediatric Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Obesity Prevention Group

Infant Safety and Injury Prevention Group

Arm Description

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

Outcomes

Primary Outcome Measures

BMI percentile at 12 months of age
Anthropometrics measured by trained study staff

Secondary Outcome Measures

Proportion of infants with BMI percentile >85th at 12 months of age
Anthropometrics measured by trained study staff

Full Information

First Posted
October 25, 2019
Last Updated
November 22, 2019
Sponsor
University of Texas at Austin
search

1. Study Identification

Unique Protocol Identification Number
NCT04177472
Brief Title
Mothers And careGivers Investing in Children
Acronym
MAGIC
Official Title
MAGIC: A Family Based Feeding Intervention Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Parenting
Keywords
nutrition, parenting, intergenerational feeding influences, sensitive feeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Primary - BMI percentile at 12 months of age Secondary- Proportion of infants with BMI percentile >85th at 12 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.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obesity Prevention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Infant Safety and Injury Prevention Group
Arm Type
No Intervention
Arm Description
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
Intervention Name(s)
Obesity Prevention Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
BMI percentile at 12 months of age
Description
Anthropometrics measured by trained study staff
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion of infants with BMI percentile >85th at 12 months of age
Description
Anthropometrics measured by trained study staff
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Infant dietary intake of fruits and vegetables, animal source foods, whole grains, desserts and sweets, and salty snacks at 11 months of age
Description
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)
Time Frame
10 to 11 months of age
Title
Responsive feeding at 10 to 11 months of age
Description
Measured using the Infant Feeding Styles Questionnaire (IFSQ) full scale
Time Frame
10 to 11 months of age
Title
Responsive feeding at 10 to 11 months of age
Description
Measured during mealtime observations using the Chatoor's feeding scale.
Time Frame
11 months of age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Jacobvitz, PhD
Phone
512-232-5879
Email
debj@austin.utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Jacobvitz, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Hazen, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Widen, PhD, RD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ladia Hernandez, PhD, RD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sarah M. & Charles E. Seay Building
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Jacobvitz, PhD
Facility Name
Dell Pediatric Research Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Widen, PhD, RD

12. IPD Sharing Statement

Learn more about this trial

Mothers And careGivers Investing in Children

We'll reach out to this number within 24 hrs