Eating BehaviorNCT03620045
An Exercise Intervention to Improve the Eating Patterns of Preadolescent Children at High Risk for Obesity
A study testing Acute moderate physical activity in people with Eating Behavior and Self-Regulation, run by University of Oregon at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Self-Regulation
- What is being tested?
- Acute moderate physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2017to 4 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8-10 years (block recruited to ensure 50% female, 50% obese)
- Rural geographic location (≥ 10 miles from a city of ≥ 40,000)
- Understand English
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Eating Behavior, Self-Regulation
- Being tested
- Acute moderate physical activity
- Medical subject headings
- Feeding Behavior, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute moderate physical activityBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Acute moderate physical activity | Experimental | Participants will walk at a moderate intensity for 20 minutes on a treadmill Receives: Behavioral: Acute moderate physical activity |
| Sedentary activity | No intervention | Participants will be permitted to read books and/or draw for 20 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
total kcal consumed during a laboratory test meal after each of two conditions
Measured: up to 14 days
Secondary outcomes (1)
Executive functioning
executive functioning performance assessed with a 3-minute task immediately after each of two conditions
Measured: Assessed immediately after each of the two experimental conditions administered during two separate study visits approximately 14 days of each other
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start14 Jun 2017
- Primary completion4 Aug 2021
- Study completion4 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover design
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nichole Kelly, University of Oregon
- Investigators
- Nichole R Kelly, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620045
- Sponsor's protocol ID
- 04252017.043
- Status last verified
- Sep 2022
- First submitted
- 27 Jul 2018
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38671287
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exercise Intervention to Improve the Eating Patterns of Preadolescent Children
- ClinicalTrials.gov ID
- NCT03620045
- Acronym / sponsor ID
- 04252017.043
- Conditions
- Eating Behavior, Self-Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 4 Aug 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| Acute moderate physical activity | Experimental | Behavioral: Acute moderate physical activityParticipants will walk at a moderate intensity for 20 minutes on a treadmill |
| Sedentary activity | No intervention | –Participants will be permitted to read books and/or draw for 20 minutes |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 8-10 years (block recruited to ensure 50% female, 50% obese)
- Rural geographic location (≥ 10 miles from a city of ≥ 40,000)
- Understand English
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute moderate physical activityFor 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 | Behavioural | Acute moderate physical activity |
Primary outcome
Energy intake
Time frame: up to 14 days
total kcal consumed during a laboratory test meal after each of two conditions
1 secondary outcome
Executive functioning
Time frame: Assessed immediately after each of the two experimental conditions administered during two separate study visits approximately 14 days of each other
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Derived from this study: PubMed 38671287Kelly 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nichole R Kelly, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute moderate physical activity in people with Eating Behavior and Self-Regulation, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03620045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.