NCT Number: NCT01513343
Promoting The Self-Regulation Of Energy Intake
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.
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Conditions
Age range
3 year–6 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Baylor College of Medicine, Houston, Texas, United States
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- Parents and children who have any kind of food allergies or diabetes or are on special diets will be excluded from the study.
Treatment and study plan
Primary outcomes
-
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.
Secondary outcomes
-
Parental Feeding Behaviors
Time frame: 12-month follow-up
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.
Sponsors and collaborators
Lead sponsor
Baylor College of Medicine
Other
Collaborators
- University of Colorado, Denver
- Washington State University
Registry information
Official study title
Promoting The Self-Regulation Of Energy Intake In Latino Preschoolers: A Family Focused Obesity Prevention Program
Acronym: SEEDs
Important dates
- Study start
- 2014
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jan 20, 2012
- Registry last updated
- May 15, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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