Obesity, ChildhoodNCT03170700
Online Videos and New Feeding Content to Enhance a Current EFNEP Program
A study testing Nutrition program with in-person parental feeding content and Nutrition program with online parental feeding content in people with Obesity, Childhood, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
The goal of this study is to further increase the impact of a validated and widely-used Eating Smart • Being Active EFNEP curriculum by teaching parents responsive feeding practices resulting in the development of healthier patterns of child eating behavior and food intake. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Nutrition program with in-person parental feeding content and Nutrition program with online parental feeding content
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 543 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2017to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents who attend EFNEP programs in the states of WA and CO.
Who cannot join
- Parents with children younger than age 2 and older than age 8 will be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Colorado State University
Fort Collins, Colorado, 80523
Washington State University
Pullman, Washington, 99164
About this study
Official title: Use of Engaging Online Videos in Conjunction With New Feeding Content to Enhance a Current EFNEP Program in the Prevention of Child Obesity
The goal of this study is to further increase the impact of a validated and widely-used Eating Smart • Being Active EFNEP curriculum by teaching parents responsive feeding practices resulting in the development of healthier patterns of child eating behavior and food intake. Additionally, the effectiveness of two delivery strategies for adding feeding video-based content will be examined (in-person versus online lessons).
Read the 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.
- Conditions
- Obesity, Childhood
- Being tested
- Nutrition program with in-person parental feeding content, Nutrition program with online parental feeding content
- Keywords
- preschool, eating behaviors, family
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition program with in-person parental feeding contentBehavioural
Participants will attend the nutrition program (Eating Smart • Being Active) and be provided with in-person parental feeding content.
Nutrition program with online parental feeding contentBehavioural
Participants will attend the nutrition program (Eating Smart • Being Active). They will access parental feeding content online.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will receive a nutrition program without parental feeding content. They will attend the nutrition program (Eating Smart • Being Active). |
| In-person | Experimental | Nutrition program with in-person parental feeding content. Receives: Behavioral: Nutrition program with in-person parental feeding content |
| Online | Experimental | Nutrition program with online parental feeding content. Receives: Behavioral: Nutrition program with online parental feeding content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responsive Feeding from the modified Child Feeding Questionnaire
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.
Measured: Up to 12-month follow up
Providing Structure from the modified Child Feeding Questionnaire
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.
Measured: Up to 12-month follow up
Novel Foods from the modified Child Feeding Questionnaire
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.
Measured: Up to 12-month follow up
Secondary outcomes (2)
Parental Knowledge Questionnaire
A questionnaire measuring aspects of feeding and nutrition knowledge and content covered in the prevention curriculum will be assessed.
Measured: Up to 12-month follow up
Child Eating Behaviors
Parental report of child eating behaviors
Measured: Up to 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start11 Sep 2017
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three conditions: 1) Nutrition Program (Eating Smart • Being Active) alone (control); 2) Nutrition program with parental feeding content (In-person); or 3) Nutrition program with parental feeding content (online).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State University, Colorado State University
- Responsible party
- Principal investigator, Sheryl Hughes, Baylor College of Medicine
- Investigators
- Sheryl O Hughes, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170700
- Sponsor's protocol ID
- H-36455
- Other IDs
- 2015-68001-23311, 2015
- Status last verified
- May 2022
- First submitted
- 8 May 2017
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Power TG, Baker SS, Barale KV, Aragon MC, Lanigan JD, Parker L, Garcia KS, Auld G, Micheli N, Hughes SO. Using Mobile Technology for Family-Based Prevention in Families with Low Incomes: Lessons from a Randomized Controlled Trial of a Childhood Obesity Prevention Program. Prev Sci. 2024 Feb;25(2):369-379. doi: 10.1007/s11121-023-01637-8. Epub 2024 Feb 7.
PubMed 38321316Hughes SO, Power TG, Baker SS, Barale KV, Aragon MC, Lanigan JD, Parker L, Silva Garcia K, Auld G, Johnston CA, Micheli N. Short-Term Efficacy of a Childhood Obesity Prevention Program Designed to Pair Feeding Content With Nutrition Education. Child Obes. 2023 Jun;19(4):239-248. doi: 10.1089/chi.2022.0030. Epub 2022 Jun 16.
PubMed 35708621
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Engaging Online Videos in Conjunction With New Feeding Content to Enhance a Current EFNEP Program in the Prevention of Child Obesity
- ClinicalTrials.gov ID
- NCT03170700
- Acronym / sponsor ID
- H-36455
- Conditions
- Obesity, Childhood
- Keywords
- preschool, eating behaviors, family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Washington State University, Colorado State University
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to further increase the impact of a validated and widely-used Eating Smart • Being Active EFNEP curriculum by teaching parents responsive feeding practices resulting in the development of healthier patterns of child eating behavior and food intake. Additionally, the effectiveness of two delivery strategies for adding feeding video-based content will be examined (in-person versus online lessons).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three conditions: 1) Nutrition Program (Eating Smart • Being Active) alone (control); 2) Nutrition program with parental feeding content (In-person); or 3) Nutrition program with parental feeding content (online).
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will receive a nutrition program without parental feeding content. They will attend the nutrition program (Eating Smart • Being Active). |
| In-person | Experimental | Behavioral: Nutrition program with in-person parental feeding contentNutrition program with in-person parental feeding content. |
| Online | Experimental | Behavioral: Nutrition program with online parental feeding contentNutrition program with online parental feeding content. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents who attend EFNEP programs in the states of WA and CO.
Key exclusion criteria (1 listed)
- Parents with children younger than age 2 and older than age 8 will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition program with in-person parental feeding contentParticipants will attend the nutrition program (Eating Smart • Being Active) and be provided with in-person parental feeding content. | Behavioural | In-person |
| Nutrition program with online parental feeding contentParticipants will attend the nutrition program (Eating Smart • Being Active). They will access parental feeding content online. | Behavioural | Online |
Primary outcome
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.
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.
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.
2 secondary outcomes
Parental Knowledge Questionnaire
Time frame: Up to 12-month follow up
Child Eating Behaviors
Time frame: Up to 12-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 38321316Power TG, Baker SS, Barale KV, Aragon MC, Lanigan JD, Parker L, Garcia KS, Auld G, Micheli N, Hughes SO. Using Mobile Technology for Family-Based Prevention in Families with Low Incomes: Lessons from a Randomized Controlled Trial of a Childhood Obesity Prevention Program. Prev Sci. 2024 Feb;25(2):369-379. doi: 10.1007/s11121-023-01637-8. Epub 2024 Feb 7.
- Derived from this study: PubMed 35708621Hughes SO, Power TG, Baker SS, Barale KV, Aragon MC, Lanigan JD, Parker L, Silva Garcia K, Auld G, Johnston CA, Micheli N. Short-Term Efficacy of a Childhood Obesity Prevention Program Designed to Pair Feeding Content With Nutrition Education. Child Obes. 2023 Jun;19(4):239-248. doi: 10.1089/chi.2022.0030. Epub 2022 Jun 16.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl O Hughes, PhD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition program with in-person parental feeding content and Nutrition program with online parental feeding content in people with Obesity, Childhood, run by Baylor College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responsive Feeding from the modified Child Feeding Questionnaire (time frame: Up to 12-month follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03170700, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.