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Completed

NCT Number: NCT02928874

Eating Phenotypes for Childhood Obesity in the Context of Familial Obesity Risk

Using an integrated approach, this study examines multiple eating traits concurrently under states of hunger and satiety. It examines the impact of short-term appetite and intake regulation on longer-term energy intake control and weight development in a cohort of ethnically diverse normal-weight and obese boys and girls with different familial predispositions to obesity.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 7-9 years of age
  • Normal-weight or overweight/obese who are at low risk or high risk for obesity based on maternal BMI
  • Like most foods served during the study
  • Be regular breakfast eaters

Exclusion criteria

  • Have serious medical conditions known to affect food intake or body weight
  • Have any developmental, medical, or psychiatric conditions that might impact study compliance
  • Have a learning disability or poor reading ability/comprehension
  • Have visual or auditory impairment
  • Are taking medications associated with developmental, medical, or psychiatric disorders or medications known to affect appetite, food intake or body weight
  • Are underweight
  • Have food allergies related to the foods served in the study or are lactose intolerant
  • Do not regularly eat breakfast
  • Do not like or cannot eat foods served during experimental meal or are unable to finish compulsory preload
  • Mothers who are pregnant

Treatment and study plan

% COMPX (low ED vs. high ED preload)

Behavioral

EAH (low ED vs. high ED snacks)

Behavioral

Primary outcomes

  1. Percent caloric compensation index (%COMPX)

    Time frame: Baseline

  2. Appetite ratings assessed via Visual Analog Scales

    Time frame: Baseline

    Appetite ratings include self-reported perceived hunger, desire to eat, prospective consumption, and fullness.

  3. Total energy intake per day (number of calories consumed over 24-hours)

    Time frame: Baseline

    Number of calories consumed over 24-hours assessed via measured food intake in the laboratory and via parent-reported food intake at home.

  4. BMI z-score

    Time frame: Change from baseline BMI z-score at 1-year follow-up

  5. Waist circumference (cm)

    Time frame: Change from baseline waist circumference at 1-year follow-up

  6. Percentage body fat

    Time frame: Change from baseline percentage body fat at 1-year follow-up

Secondary outcomes

  1. Eating in the absence of hunger (kcal)

    Time frame: Baseline (number of calories consumed from snacks)

  2. Home food environment

    Time frame: Baseline home food environment assessed using the Home Food Inventory

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Oct 10, 2016
Registry last updated
Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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