An Exercise Intervention to Improve the Eating Patterns of Preadolescent Children at High Risk for Obesity

Eating Behavior Clinical Trial

Official title:

An Exercise Intervention to Improve the Eating Patterns of Preadolescent Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620045
• Other study ID #: 04252017.043
• Status: Completed
• Phase: N/A
• Start date: June 14, 2017
• Est. completion date: August 4, 2021

Study information

• Verified date: September 2022
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Children in rural communities experience significant obesity-related health disparities; they are 26%-55% more likely to be obese and less likely to have health insurance and access to weight management specialists than are their urban peers. Geographic-specific disparities in obesity may be due, in part, to variations in eating behaviors. Children in rural communities describe purchasing and consuming significantly more energy-dense, low-nutrient food items relative to their urban peers. Existing behavioral strategies for improving children's EI patterns have largely been ineffective in reducing risk for excess weight gain. The primary aim of the proposed study is to test the effects of a brief, novel strategy for improving rural children's eating behaviors. Specifically, the study aims to harness the well-documented benefits of an acute bout (20 min) of moderate physical exercise on children's executive functioning, and to see if these cognitive changes lead to better self-regulation of eating. If 20 min of moderate physical exercise is associated with observed improvements in preadolescent children's eating secondary to increases in executive functioning, these data may offer explicit targets for an obesity prevention trial in rural Oregon elementary schools.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 4, 2021
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

Inclusion criteria:

• 8-10 years (block recruited to ensure 50% female, 50% obese)

• Rural geographic location (= 10 miles from a city of = 40,000)

• Understand English

Exclusion criteria

• BMI < 5th percentile

• Major medical condition, current full-threshold psychiatric diagnosis, or moderate suicide risk (e.g., plan or intent)

• Current or recent use (< 3 months) of medication known to affect body weight or energy intake

• Recent brain injuries that would be expected to affect neuropsychological functioning

• Mobility impairments that would impede their ability to walk on a treadmill

• Estimated full-scale intelligence quotient score = 70

• History of pregnancy

• Significant food allergies that would prevent them from safely consuming the study's breakfast and lunch meals

• Responses on a food preference questionnaire that suggest that they do not like (i.e., rated them below 6 on a scale from 1 to 10) at least 50% of the food items offered in the lunch test meal

Related Conditions & MeSH terms

• Eating Behavior
• Self-Regulation

Intervention

Behavioral:
• Acute moderate physical activity
For 20 minutes, participants will walk on a treadmill at a moderate intensity based on a combination of evidence-based and pre-determined parameters, including ratings of perceived exertion and heart rate

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy intake	total kcal consumed during a laboratory test meal after each of two conditions	up to 14 days
Secondary	Executive functioning	executive functioning performance assessed with a 3-minute task immediately after each of two conditions	Assessed immediately after each of the two experimental conditions administered during two separate study visits approximately 14 days of each other