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

NCT02928874 | Completed

• 1 other identifier: 820661
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (6)

• Percent caloric compensation index (%COMPX)

  Baseline

• Appetite ratings assessed via Visual Analog Scales

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

  Baseline

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

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

  Baseline

• BMI z-score

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

• Waist circumference (cm)

  Change from baseline waist circumference at 1-year follow-up

• Percentage body fat

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

Secondary Outcomes (2)

• Eating in the absence of hunger (kcal)

  Baseline (number of calories consumed from snacks)

• Home food environment

  Baseline home food environment assessed using the Home Food Inventory

Study Arms (2)

Caloric compensation

EXPERIMENTAL

Twenty-five minutes before breakfast, participants will be asked to consume in full one of two oatmeal preloads that will vary in ED. The order of preload conditions will be randomized across groups of children participating in the visits.

Behavioral: % COMPX (low ED vs. high ED preload)

Eating in the absence of hunger (EAH)

EXPERIMENTAL

During both study visits, children's EAH will be assessed after lunch and again after dinner. The order of presenting the low and high ED snacks will be counterbalanced across meals.

Behavioral: EAH (low ED vs. high ED snacks)

Interventions

% COMPX (low ED vs. high ED preload) BEHAVIORAL

Caloric compensation

EAH (low ED vs. high ED snacks) BEHAVIORAL

Eating in the absence of hunger (EAH)

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Kral TVE, Moore RH, Chittams J, O'Malley L, Jones E, Quinn RJ, Fisher JO. Caloric compensation and appetite control in children of different weight status and predisposition to obesity. Appetite. 2020 Aug 1;151:104701. doi: 10.1016/j.appet.2020.104701. Epub 2020 Apr 11.

  PMID: 32289325 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Tanja Kral, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 10, 2016
• Study Start: September 1, 2014
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

US (1)