- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06111040
Nurturing Needs Study: Parenting Food Motivated Children
Deconstructing Food Parenting Approaches to Obesity Prevention for the Highly Food Motivated Child
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christina Croce, MS
- Phone Number: 215-707-8672
- Email: christina.croce@temple.edu
Study Contact Backup
- Name: Nilda Micheli, BS
- Phone Number: 713-798-6737
- Email: nildam@bcm.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140
- Recruiting
- Temple University - Center for Obesity Research and Education
-
Contact:
- Christina Croce, MS
- Phone Number: 267-428-7893
- Email: nurturingneeds@temple.edu
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- USDA/ARS Children's Nutrition Research Center
-
Contact:
- Nilda Micheli, BS
- Phone Number: 713-798-6737
- Email: nildam@bcm.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- Child ages 4 or 5 years at baseline;
- Parent/ primary caregiver with legal representation (having 50% or more custody of child);
- Parent/primary caregiver reporting primary responsibility for child feeding outside of childcare (being with child when they are eating at least two times daily);
- 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:
- Parent/primary caregiver <18 years of age;
- Child history of major food allergies (e.g., peanuts);
- 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;
- Foster child.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Caregiver-child dyads
A cohort of 205 caregivers and 205 children aged 4-5 years at baseline will be recruited and followed longitudinally for 18 months.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Excessive dietary intakes
Time Frame: Baseline, 18 months
|
Indicators: SFAS intakes and meal/snack sizes estimated from 24-hour dietary recalls
|
Baseline, 18 months
|
|
BMI change
Time Frame: Baseline, 18 months
|
% of the 50th percentile per age- and sex-specific CDC reference values for BMI on a log scale
|
Baseline, 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Observed food motivated behaviors
Time Frame: Baseline, 18 months
|
Indicators: Eating in the absence of hunger and relative reinforcing value of food
|
Baseline, 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sheryl O Hughes, PhD, Baylor College of Medicine
- Principal Investigator: Jennifer O Fisher, PhD, Temple University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Overweight
- Obesity
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Behavior, Animal
- Pediatric Obesity
- Feeding Behavior
- Investigative Techniques
- Diet, Food, and Nutrition
- Physiological Phenomena
- Nutritional Physiological Phenomena
- Digestive System Physiological Phenomena
- Digestive System and Oral Physiological Phenomena
- Weights and Measures
- Eating
Other Study ID Numbers
- R01DK132642 (U.S. NIH Grant/Contract)
- 30291 (Other Identifier: Temple Institutional Review Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Researchers will work with the University Libraries Research Data Management Services staff to facilitate the deposit of data into TUScholarShare, and to ensure appropriate metadata and complete documentation of the data to maximize the ability to understand and reuse the data. The data will be published in TUScholarShare for long-term preservation, using services such as file format migration where possible, persistent identifiers (DOIs), persistent Web addresses (handles), and checksums.
TUScholarShare data resides in two locations, a local Isilon storage system and an off-site cloud-based service, Open Repository. Open Repository's AWS cloud storage service provides extended infrastructure, which includes a production server, test server, fallback servers, data backups, and full system backups
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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