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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06111040
Other study ID # R01DK132642
Secondary ID 30291
Status Recruiting
Phase N/A
First received
Last updated
Start date September 7, 2023
Est. completion date September 30, 2027

Study information

Verified date January 2024
Source Temple University
Contact Christina Croce, MS
Phone 215-707-8672
Email christina.croce@temple.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

High food motivation among children is trait-like and increases risks of unhealthy dietary intake and obesity. Scientific knowledge of how parenting can best support healthy eating habits and growth among children who are predisposed to overeating is surprisingly limited. This investigation will identify supportive food parenting approaches for obesity prevention that address the needs of highly food motivated children.


Description:

High levels of food motivation among young children are heritable, track over time, and associated with elevated risks of unhealthy eating and obesity. Despite significant growth of family-based obesity prevention efforts, the evidence base is remarkably scant on parenting highly food motivated children to prevent obesity and poor dietary outcomes. The need to move away from a "one-size-fits-all" approach to food parenting is particularly pronounced for children from racial and ethnic minority families with low income that experience greater disparities in obesity, are underrepresented in the food parenting and family-based prevention literatures, and for whom prevention efforts have had limited success to date. The goal of this investigation is to generate a robust basic science evidence for parenting highly food motivated children to prevent excessive dietary intakes and body mass index (BMI) gains during the preschool years among racial and ethnic minority families with low incomes. Using a prospective cohort design, this investigation follow 375 Hispanic and Black caregiver/child dyads with low incomes over 18 months as children transition from preschool to elementary school, when significant numbers of children begin to experience problems of poor diet quality and obesity. Children with varying food motivation will be recruited to understand whether highly food motivated children have different needs than other children. A multi-method approach will use state-of-the-art measures, including ecological momentary assessment, to comprehensively investigate the amount, types, and consistency of food parenting practices (i.e., specific, goal-oriented behaviors) needed to prevent food motivated behaviors, excessive dietary intake, and BMI gains in children. Specifically, the role of structure (i.e., theoretically supportive) and its differentiation from more coercive types of food parenting control will be comprehensively characterized.


Recruitment information / eligibility

Status Recruiting
Enrollment 750
Est. completion date September 30, 2027
Est. primary completion date September 30, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 5 Years
Eligibility Inclusion Criteria: 1. Hispanic or Black parent/primary caregiver race/ethnicity, based on the participating caregiver's self-disclosure; 2. Low household income, based on US poverty income guidelines for WIC/Head Start eligibility; 3. Child ages 4 or 5 years at baseline; 4. Parent/ primary caregiver with legal representation (having 50% or more custody of child); 5. Parent/primary caregiver reporting primary responsibility for child feeding outside of childcare (being with child when they are eating at least two times daily); 6. Caregiver with a cell phone that can be used to send and receive text messages. If there is more than one age-eligible child in the family, we will ask the caregiver to pick the index child. Exclusion Criteria: 1. Parent/primary caregiver <18 years of age; 2. Child history of major food allergies (e.g., peanuts); 3. Child medication use (e.g., insulin), developmental disability (e.g., autism) or medical condition(s) (e.g., diabetes) known to affect food intake and growth; 4. Foster child.

Study Design


Intervention

Other:
Measurement
The only interventions are at the measurement level and consist of two behavioral protocols designed to assess children's eating behavior, where food stimuli are provided and children's behavioral responses are recorded.

Locations

Country Name City State
United States USDA/ARS Children's Nutrition Research Center Houston Texas
United States Temple University - Center for Obesity Research and Education Philadelphia Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Temple University Baylor College of Medicine, University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fisher JO, Hughes SO, Miller AL, Horodynski MA, Brophy-Herb HE, Contreras DA, Kaciroti N, Peterson KE, Rosenblum KL, Appugliese D, Lumeng JC. Characteristics of eating behavior profiles among preschoolers with low-income backgrounds: a person-centered analysis. Int J Behav Nutr Phys Act. 2022 Jul 23;19(1):91. doi: 10.1186/s12966-022-01323-y. Erratum In: Int J Behav Nutr Phys Act. 2022 Aug 8;19(1):103. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Excessive dietary intakes Indicators: SFAS intakes and meal/snack sizes estimated from 24-hour dietary recalls Baseline, 18 months
Primary BMI change % of the 50th percentile per age- and sex-specific CDC reference values for BMI on a log scale Baseline, 18 months
Secondary Observed food motivated behaviors Indicators: Eating in the absence of hunger and relative reinforcing value of food Baseline, 18 months
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