ObesitySEEDsNCT01513343
Promoting The Self-Regulation Of Energy Intake
A study testing Parent and child groups focused on self-regulation of eating in people with Obesity, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
The goal of this study is to develop and test the efficacy of a scientifically-based, culturally competent seven-session parent directed, obesity prevention program focused on parental feeding strategies that support young children's self-regulation of intake. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Parent and child groups focused on self-regulation of eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to 27 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents whose children attend Head Start with the sample of children equally split on gender and ethnicity,
- with representation from ages 3 to 6 years.
Who cannot join
- Parents and children who have any kind of food allergies or diabetes or are on special diets will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
Thomas G. Power
Pullman, Washington
About this study
Official title: Promoting The Self-Regulation Of Energy Intake In Latino Preschoolers: A Family Focused Obesity Prevention Program
The goal of this study is to develop and test the efficacy of a scientifically-based, culturally competent seven-session parent directed, obesity prevention program focused on parental feeding strategies that support young children's self-regulation of intake.
Read the detailed description
The intervention program was developed and piloted. Expected outcomes: At the end of the intervention program, it is expected that parents in the intervention group will: 1) use more child-centered (e.g., repeated presentation of new foods, involvement in food preparation) and less parent-centered feeding directives; 2) be less likely to show an indulgent and more likely to show an authoritative feeding style (feeding responsiveness); 3) show lower scores on restriction and pressure to eat and higher scores on monitoring; and 4) demonstrate higher levels of food knowledge (e.g., best feeding practices, reduced feeding misconceptions). Children in the intervention group are expected to: 1) show more willingness to try new foods, and 2) show increased self-regulation of energy intake. At the end of the interventions, children are expected to show greater consumption of fruits and vegetables (including consuming a wider variety of fruits and vegetables). All effects are expected to continue through the 6- and 12-month follow-ups, although the effects sizes will diminish. Although we do not expect effects on BMI after 6 weeks, we expect to see decreases in children's BMI percentiles by the 6- and 12-month follow-ups for the intervention group-especially for the top 25% of the BMI percentile range. No parental BMI effects are expected.
- Conditions
- Obesity
- Being tested
- Parent and child groups focused on self-regulation of eating
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent and child groups focused on self-regulation of eatingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Parent and child classes (prevention group) | Experimental | Parent and child groups focused on self-regulation of eating Receives: Behavioral: Parent and child groups focused on self-regulation of eating |
| Treatment as usual (control group) | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's BMI Percentiles
Measured child height and weight data were collected. Two height and weight measures were averaged for each child. Age- and gender-specific BMI z-scores for each child were calculated. Children were classified into healthy weight (5th to <85th percentile), overweight (≥85th to <95th percentile), and obese (≥95th percentile) according to Centers for Disease Control and Prevention standards.
Measured: 12-month follow-up
Secondary outcomes (1)
Parental Feeding Behaviors
Questionnaire data (parent-report). Subscale scores from the Food Parenting Inventory and Feeding Knowledge Questionnaire were used to measure secondary outcomes. All scales included response categories ranging from 1 to 5. Higher scores were considered better on the following subscales: repeated presentation of new foods; measured child portion sizes; child involvement in food preparation; feeding responsiveness; knowledge of best feeding practices; feeding efficacy. Lower scores were considered better on the subscale of feeding misconceptions.
Measured: 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 posted20 Jan 2012 (estimated)
- Study startAug 2014
- Primary completion27 Dec 2017
- Study completion27 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State University, University of Colorado, Denver
- 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
- NCT01513343
- Sponsor's protocol ID
- USDA 2011-68001-30009
- Other IDs
- H-28013
- Acronym
- SEEDs
- Status last verified
- Jun 2022
- First submitted
- 17 Jan 2012
- Last updated
- 15 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting The Self-Regulation Of Energy Intake In Latino Preschoolers: A Family Focused Obesity Prevention Program
- ClinicalTrials.gov ID
- NCT01513343
- Acronym / sponsor ID
- SEEDs / USDA 2011-68001-30009
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Washington State University, University of Colorado, Denver
- Study start
- Aug 2014
- Primary completion
- 27 Dec 2017 (actual)
- Study completion
- 27 Dec 2017 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Posted 15 May 2023
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 develop and test the efficacy of a scientifically-based, culturally competent seven-session parent directed, obesity prevention program focused on parental feeding strategies that support young children's self-regulation of intake.
Detailed description
The intervention program was developed and piloted. Expected outcomes: At the end of the intervention program, it is expected that parents in the intervention group will: 1) use more child-centered (e.g., repeated presentation of new foods, involvement in food preparation) and less parent-centered feeding directives; 2) be less likely to show an indulgent and more likely to show an authoritative feeding style (feeding responsiveness); 3) show lower scores on restriction and pressure to eat and higher scores on monitoring; and 4) demonstrate higher levels of food knowledge (e.g., best feeding practices, reduced feeding misconceptions). Children in the intervention group are expected to: 1) show more willingness to try new foods, and 2) show increased self-regulation of energy intake. At the end of the interventions, children are expected to show greater consumption of fruits and vegetables (including consuming a wider variety of fruits and vegetables). All effects are expected to continue through the 6- and 12-month follow-ups, although the effects sizes will diminish. Although we do not expect effects on BMI after 6 weeks, we expect to see decreases in children's BMI percentiles by the 6- and 12-month follow-ups for the intervention group-especially for the top 25% of the BMI percentile range. No parental BMI effects are expected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent and child classes (prevention group) | Experimental | Behavioral: Parent and child groups focused on self-regulation of eatingParent and child groups focused on self-regulation of eating |
| Treatment as usual (control group) | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parents whose children attend Head Start with the sample of children equally split on gender and ethnicity,
- with representation from ages 3 to 6 years.
Key exclusion criteria (1 listed)
- Parents and children who have any kind of food allergies or diabetes or are on special diets will be excluded from the study.
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 |
|---|---|---|
| Parent and child groups focused on self-regulation of eating | Behavioural | Parent and child classes (prevention group) |
Primary outcome
Children's BMI Percentiles
Time frame: 12-month follow-up
Measured child height and weight data were collected. Two height and weight measures were averaged for each child. Age- and gender-specific BMI z-scores for each child were calculated. Children were classified into healthy weight (5th to <85th percentile), overweight (≥85th to <95th percentile), and obese (≥95th percentile) according to Centers for Disease Control and Prevention standards.
1 secondary outcome
Parental Feeding Behaviors
Time frame: 12-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Parent and child groups focused on self-regulation of eating in people with Obesity, 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 2 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 15 May 2023. 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?
Yes. Results are posted in the registry (first posted 15 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Children's BMI Percentiles (time frame: 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2023.