- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03170700
Online Videos and New Feeding Content to Enhance a Current EFNEP Program
Use of Engaging Online Videos in Conjunction With New Feeding Content to Enhance a Current EFNEP Program in the Prevention of Child Obesity
Study Overview
Status
Conditions
Detailed Description
During Phase I of the project (first two years), the leadership team composed of both research and extension investigators will work with the media production team to edit the SEEDS videotapes to meet the needs of the current project and to develop the website and activities for use in the online condition. Phase II (second three years) will be a large scale evaluation of this program. In this phase, classes of EFNEP participants in Colorado and Washington will be randomly assigned to one of three conditions: 1) Eating Smart • Being Active alone (control); 2) Eating Smart • Being Active plus feeding videos at the weekly EFNEP sessions, plus facilitated group discussion (in-person); or 3) Eating Smart • Being Active plus online videos and activities, (online). Pre- and post-program assessments, 6- and 12-month follow ups will be conducted to assess responsive feeding, providing structure, food exploration, child eating behaviors, parent knowledge, and child dietary intake. Child dietary intake will be obtained on a sub-sample of 90 participants. In Phase III, the investigators will begin dissemination.
A total of 543 participants were recruited in five locations to participate in the project: 262 from three counties in Colorado and 281 from three counties in Washington (English and Spanish participants). A total of 4 to 10 mothers were recruited for each group. After recruitment, groups were randomly assigned to the three conditions ensuring a relatively equal number of participants per condition.
Data from children who have any kind of food allergies or diabetes or are on special diet will be excluded from the analyses.
To ensure program fidelity, program educators will complete implementation checklists, and 20% of the sessions will be attended by an additional grant staff member to conduct implementation observations and assess participant engagement. Detailed records of participant attendance will be collected to assess dosage effects and attrition. All assessments will be conducted by grant project staff blind to the group status of the participants. Retention of participants will be maximized using strategies such as obtaining multiple phone numbers for each family; obtaining external contact information for siblings and close friends; sending interim reminders with the goal of fostering contact should the family move; and phone calls, emails or letters between data collection points to each family.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Fort Collins, Colorado, United States, 80523
- Colorado State University
-
-
Washington
-
Pullman, Washington, United States, 99164
- Washington State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parents who attend EFNEP programs in the states of WA and CO.
Exclusion Criteria:
- Parents with children younger than age 2 and older than age 8 will be excluded.
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 |
---|---|
No Intervention: Control
Participants will receive a nutrition program without parental feeding content.
They will attend the nutrition program (Eating Smart • Being Active).
|
|
Experimental: In-person
Nutrition program with in-person parental feeding content.
|
Participants will attend the nutrition program (Eating Smart • Being Active) and be provided with in-person parental feeding content.
|
Experimental: Online
Nutrition program with online parental feeding content.
|
Participants will attend the nutrition program (Eating Smart • Being Active).
They will access parental feeding content online.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Responsive Feeding from the modified Child Feeding Questionnaire
Time Frame: Up to 12-month follow up
|
Five subscales measuring responsiveness, restriction, use of food as reward, monitoring, and pressure to eat will be assessed using a 5-point Likert scale.
Parents will report on these constructs that assess responsive feeding.
|
Up to 12-month follow up
|
Providing Structure from the modified Child Feeding Questionnaire
Time Frame: Up to 12-month follow up
|
Seven subscales measuring parent decides on portions, family meals, serves measured portions, child helps prepare, eat whenever, indulgent feeding, and eat at regular times will be assessed using a 5-point Likert scale.
Parents will report on these constructs that assess responsive feeding.
|
Up to 12-month follow up
|
Novel Foods from the modified Child Feeding Questionnaire
Time Frame: Up to 12-month follow up
|
Four subscales measuring encouraging exploration, offering new foods, urging new foods, and low pressure strategies for encouragement will be assessed using a 5-point Likert scale.
Parents will report on these constructs that assess responsive feeding.
|
Up to 12-month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental Knowledge Questionnaire
Time Frame: Up to 12-month follow up
|
A questionnaire measuring aspects of feeding and nutrition knowledge and content covered in the prevention curriculum will be assessed.
|
Up to 12-month follow up
|
Child Eating Behaviors
Time Frame: Up to 12-month follow up
|
Parental report of child eating behaviors
|
Up to 12-month follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sheryl O Hughes, PhD, Baylor College of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-36455
- 2015-68001-23311 (Other Identifier: USDA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Obesity, Childhood
-
Universiteit LeidenWageningen University; Nutricia, Inc.; Danone ResearchCompletedChildhood Obesity | Childhood Overweight | Vegetable Acceptance in Early ChildhoodNetherlands
-
Oregon State UniversityCompletedChildhood Obesity Prevention
-
The Miriam HospitalHassenfeld Child Health Innovation InstituteCompletedChildhood Obesity PreventionUnited States
-
Fundacion para la Formacion e Investigacion Sanitarias...UnknownChildhood Obesity PreventionSpain
-
Tampere UniversitySeinajoki Central Hospital; Tampere University Hospital; Foundation for Paediatric... and other collaboratorsCompleted
-
Vanderbilt University Medical CenterActive, not recruitingPediatric Obesity | Childhood Obesity | Childhood Onset ObesityUnited States
-
Tehran University of Medical SciencesUnknownChildhood Obesity PreventionIran, Islamic Republic of
-
Cornell UniversityCompletedChildhood Obesity Prevention
-
Harokopio UniversityCompletedPrevention of Childhood ObesityGreece
-
Universidad Autonoma de San Luis PotosíCompletedChildhood Obesity | Childhood OverweightMexico
Clinical Trials on Nutrition program with in-person parental feeding content
-
Fundació Sant Joan de DéuRecruitingAutism Spectrum DisorderSpain
-
Göteborg UniversityKarolinska University Hospital; The Swedish Research Council; Swedish Council... and other collaboratorsRecruiting