Clinical trial NCT03620045: An Exercise Intervention to Improve the Eating Patterns of Preadolescent Children at High Risk for Obesity
Official title: An Exercise Intervention to Improve the Eating Patterns of Preadolescent Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Self-Regulation
Lead sponsor: University of Oregon
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 92
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover design
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Energy intake
timeFrame: up to 14 days
Secondary outcomes:
measure: Executive functioning
timeFrame: Assessed immediately after each of the two experimental conditions administered during two separate study visits approximately 14 days of each other
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Nichole R Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
References: