- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04177472
Mothers And careGivers Investing in Children (MAGIC)
MAGIC: A Family Based Feeding Intervention Program
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Deborah Jacobvitz, PhD
- Phone Number: 512-232-5879
- Email: debj@austin.utexas.edu
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- Recruiting
- Sarah M. & Charles E. Seay Building
-
Contact:
- Deborah Jacobvitz, PhD
-
Austin, Texas, United States, 78723
- Recruiting
- Dell Pediatric Research Institute
-
Contact:
- Elizabeth Widen, PhD, RD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI percentile at 12 months of age
Time Frame: 12 months
|
Anthropometrics measured by trained study staff
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of infants with BMI percentile >85th at 12 months of age
Time Frame: 12 months
|
Anthropometrics measured by trained study staff
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant dietary intake of fruits and vegetables, animal source foods, whole grains, desserts and sweets, and salty snacks at 11 months of age
Time Frame: 10 to 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
|
Responsive feeding at 10 to 11 months of age
Time Frame: 10 to 11 months of age
|
Measured using the Infant Feeding Styles Questionnaire (IFSQ) full scale
|
10 to 11 months of age
|
Responsive feeding at 10 to 11 months of age
Time Frame: 11 months of age
|
Measured during mealtime observations using the Chatoor's feeding scale.
|
11 months of age
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Deborah Jacobvitz, PhD, University of Texas at Austin
- Principal Investigator: Nancy Hazen, PhD, University of Texas at Austin
- Principal Investigator: Elizabeth Widen, PhD, RD, University of Texas at Austin
- Principal Investigator: Ladia Hernandez, PhD, RD, University of Texas at Austin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- StDavids2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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