NCT02585518

Brief Summary

The current study seeks to elucidate the context of pathological and non-pathological eating behavior in a heterogeneous sample of overweight and obese children, aged 8-14 years. Children will undergo a two-week ecological momentary assessment (EMA) protocol in which they record all eating episodes and their physiological, emotional, interpersonal, and environmental correlates. Specific aims are to identify proximal antecedents and consequences of pathological and non-pathological eating in overweight and obese children, and to determine the prevalence of loss of control eating in the natural environment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

October 21, 2015

Last Update Submit

May 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Eating episodes

    Repeated measures throughout the 2-week EMA protocol

Study Arms (2)

Obese

Children and adolescents with a BMI at or above the 85th percentile for age and sex

Healthy control

Children and adolescents with a BMI below the 85th percentile for age and sex

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Participants will comprise 40 overweight or obese (BMI≥85th %ile) youth aged 8-14 years. Every effort will be made to recruit a racially/ethnically diverse sample. Participants will be excluded if they 1) are currently taking any medications known to affect weight or appetite (e.g., antidepressants, steroids, chemotherapy drugs); 2) have a current or past diagnosis of an eating disorder involving purging or suppressed body weight (e.g., bulimia nervosa or anorexia nervosa); 3) are unable to read and understand English fluently; or 4) are receiving concurrent treatment for obesity.

You may qualify if:

  • Participants be included if they are overweight or obese (BMI≥85th %ile) and aged 8-14 years.

You may not qualify if:

  • Participants will be excluded if they 1) are currently taking any medications known to affect weight or appetite (e.g., antidepressants, steroids, chemotherapy drugs); 2) have a current or past diagnosis of an eating disorder involving purging or suppressed body weight (e.g., bulimia nervosa or anorexia nervosa); 3) are unable to read and understand English fluently; or 4) are receiving concurrent treatment for obesity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrea Goldschmidt, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 23, 2015

Study Start

February 1, 2015

Primary Completion

January 21, 2017

Study Completion

May 1, 2017

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations