NCT03620045

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2021

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

4.1 years

First QC Date

July 27, 2018

Last Update Submit

September 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Energy intake

    total kcal consumed during a laboratory test meal after each of two conditions

    up to 14 days

Secondary Outcomes (1)

  • Executive functioning

    Assessed immediately after each of the two experimental conditions administered during two separate study visits approximately 14 days of each other

Study Arms (2)

Acute moderate physical activity

EXPERIMENTAL

Participants will walk at a moderate intensity for 20 minutes on a treadmill

Behavioral: Acute moderate physical activity

Sedentary activity

NO INTERVENTION

Participants will be permitted to read books and/or draw for 20 minutes

Interventions

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

Acute moderate physical activity

Eligibility Criteria

Age8 Years - 10 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsWe do not confirm sex based on any biological testing; as such, we will rely on self- and parent-reported gender identity for each participating child; we have no exclusion criteria based on gender
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years (block recruited to ensure 50% female, 50% obese)
  • Rural geographic location (≥ 10 miles from a city of ≥ 40,000)
  • Understand English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon

Eugene, Oregon, 97401, United States

Location

Related Publications (1)

  • Kelly NR, Guidinger C, Swan DM, Thivel D, Folger A, Luther GM, Hahn ME. A brief bout of moderate intensity physical activity improves preadolescent children's behavioral inhibition but does not change their energy intake. J Behav Med. 2024 Aug;47(4):692-706. doi: 10.1007/s10865-024-00495-1. Epub 2024 Apr 26.

MeSH Terms

Conditions

Feeding BehaviorSelf-Control

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorSocial Behavior

Study Officials

  • Nichole R Kelly, PhD

    University of Oregon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomized crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 8, 2018

Study Start

June 14, 2017

Primary Completion

August 4, 2021

Study Completion

August 4, 2021

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations