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

An Exercise Intervention to Improve the Eating Patterns of Preadolescent Children

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.

Study Overview

• Status: Completed
• Conditions: Eating Behavior; Self-Regulation
• Intervention / Treatment: Behavioral: Acute moderate physical activity

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97401
      • University of Oregon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute moderate physical activity; Participants will walk at a moderate intensity for 20 minutes on a treadmill	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
No Intervention: Sedentary activity; Participants will be permitted to read books and/or draw for 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy intake	total kcal consumed during a laboratory test meal after each of two conditions	up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Oregon
• Investigators: Principal Investigator: Nichole R Kelly, PhD, University of Oregon

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): August 4, 2021
• Study Completion (Actual): August 4, 2021

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 04252017.043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No