Translating Habituation Research to Interventions for Pediatric Obesity

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01208870

Acronym

EAT

Enrollment

Registered

2010-09-24

Start date

2009-10-31

Completion date

2014-03-31

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Habituation, Pediatric Obesity

Brief summary

The purpose of this center grant is to translate basic behavioral science on habituation theory into clinical intervention using a vertical hierarchical approach from laboratory studies to field studies to the clinical intervention to improve weight loss outcomes in pediatric obesity treatment.

Detailed description

Habituation is one factor that may be related to excess energy intake. Research has shown that the rate of habituation is inversely related to the amount of food consumed and slower habituation may be a factor that is relevant to obesity, as overweight youth and adults habituate slower and consume more energy than their peers. Habituation is a basic form of learning that is observed in many response systems. We believe that habituation is an important process that mediates food regulation during a meal and across meals. However, there has been no research in children that translates basic research on habituation to food into clinical interventions for pediatric obesity. In the first phase, we will implement a series of laboratory studies to assess the effects of stimulus specificity and variety and the simultaneous reduction of variety for high energy density foods on short (within meal) and long-term (across meal) habituation. The second phase is designed to implement a series of field studies that will extend basic research from the first phase as well as define the optimal interval for reducing variety to facilitate long-term habituation to high energy density foods in the natural environment. The third phase is designed to develop and pilot test a family-based behavioral intervention for children that incorporates findings from phase2 into a clinical intervention.

Interventions

BEHAVIORALVariety Group

The intervention will consist of our traditional family based weight control intervention with elements of reducing variety of high energy dense foods for the variety group.

BEHAVIORALNutrition Education Control

The intervention will consist of our traditional family based weight control intervention.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

8 Years to 12 Years

Healthy volunteers

Yes

Inclusion criteria

* Children ages 8-12 years of age * At or above 85th BMI percentile * Children must eat almost all meals with the exception of school lunch with the family. * Overweight parent

Exclusion criteria

* Children who do not like the study foods, who are allergic to the study foods or who are on special diets and cannot consume the study foods. * Families with children with a co-morbid psychiatric diagnosis or parents who are depressed, have schizophrenia, substance abuse or a history of eating disorders. * The parent and child must not have any physical restrictions that would preclude them from making the requisite behavioral changes. * Children must be able to read at a 3rd grade reading level and must be able to demonstrate the ability to keep dietary and activity records in a stimulated interview.

Design outcomes

Primary

Measure	Time frame	Description
Change of Child Body Composition	Baseline to 6 months	Child percent overweight difference from baseline to 6 month. The formula used to derive weight loss percentage was weight lost at 6 months divided by starting weight, multiplied by 100.
Change Parent Body Composition	Baseline to 6 months	Parent Body Mass Index (kg/m\^2) difference from baseline to 6 months

Secondary

Measure	Time frame	Description
Change in Dietary Intake of Calories	Baseline to 6 months	Energy intake was calculated for parents and children as the different from baseline to six months of calories consumed. The first pilot used the calories generated from the Food Frequency Questionnaire (FFQ) report however the second pilot used calories from 24 hour recalls based on the Center of Disease Control data base or food labels.
Change in Parent Delay Discounting	Baseline to 6 months	Kirby, small, medium and large reinforcers. The Kirby monetary choice questionnaire will be used to measure implusivity in parents and children. Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards. An estimate of the participant's discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in K-values. (0.25 impulsive to 0.00016 not impulsive)
Change in Child Delay Discounting	Baseline to 6 months	Kirby, small, medium and large reinforcers. The Kirby monetary choice questionnaire will be used to measure impulsivity in parents and children. Participants are presented with a set of 27 choices between smaller immediate rewards and larger delayed rewards. An estimate of the participant's discounting rate parameter can be made from the pattern of choices and participants who discount the value of the delayed rewards more steeply are said to be more impulsive as measured in higher K-values (0.25 vs 0.00016).
Changes in Variety Measures	Baseline to 6 months	Variety of high energy density foods (RED) and low energy density foods (GREEN) were calculated from the Food Frequency Questionnaire (FFQ) for pilot 1 and 24 hour recalls (24-HR) for pilot 2. High energy dense food or Red foods are low in nutrient density. Most Red foods come from the Fats, Oils and Sweets groups and are to be used sparingly. Modified foods from the Fats, Oils, and Sweets group are still considered to be Red foods, even if their energy level is low. These foods contribute little nutrients to the diet and compete for consumption of healthier foods. Green foods are high in nutrient density and low in energy density. Most Green foods come from the fruit and vegetable groups. Serving sizes were based off the serving sizes used in United States Department of Agriculture (USDA) common serving sizes. Coding was based on the serving sizes of the specified food items and used to calculate the changes from baseline to six months.

Countries

United States

Participant flow

Recruitment details

Recruitment in the Western New York area targeted obese and overweight families through pediatric offices and the local community during 2011-2013.

Pre-assignment details

Interested eligible families are oriented, consented, screened, and offered to start the study. There were 94 participants (47 parents and 47 children) eligible to start and 4 participants (2 parents and 2 children) declined before starting the study.

Participants by arm

Arm	Count
Experimental Group Traditional family based weight control program with components from habituation theory incorporated into the treatment. Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group.	46
Nutrition Education Control Traditional family based weight control program, without components of habituation theory incorporated. Habituation theory and Pediatric Obesity: The intervention will consist of our traditional family based weight control intervention with elements of habituation theory included for the experimental group.	44
Total	90

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	2	8

Baseline characteristics

Characteristic	Experimental Group	Nutrition Education Control	Total
Age, Customized Child Age n=23 Experimental n=22 Control	10.6 years STANDARD_DEVIATION 1.3	10.8 years STANDARD_DEVIATION 1.4	10.7 years STANDARD_DEVIATION 1.3
Age, Customized Parent Age n=23 Experimental, n=22 Control	43.2 years STANDARD_DEVIATION 6.6	43.0 years STANDARD_DEVIATION 6.4	43.1 years STANDARD_DEVIATION 6.4
Child percent overweight (%)	77.1 Percent overweight based on BMI charts STANDARD_DEVIATION 40	71.8 Percent overweight based on BMI charts STANDARD_DEVIATION 29.2	74.5 Percent overweight based on BMI charts STANDARD_DEVIATION 33.6
Child z-Body Mass Index	2.2 [1] z-BMI see description STANDARD_DEVIATION 0.4	2.2 [1] z-BMI see description STANDARD_DEVIATION 0.4	2.2 [1] z-BMI see description STANDARD_DEVIATION 0.4
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	2 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants	42 Participants	88 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Parent Body Mass Index (kg/m^2)	38.9 kg/m^2 STANDARD_DEVIATION 8.2	37.2 kg/m^2 STANDARD_DEVIATION 6.8	38.1 kg/m^2 STANDARD_DEVIATION 7.5
Parent Weight (lb.)	236.8 pounds STANDARD_DEVIATION 48.7	232.5 pounds STANDARD_DEVIATION 46.2	234.7 pounds STANDARD_DEVIATION 47
Race (NIH/OMB) American Indian or Alaska Native	2 Participants	0 Participants	2 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	6 Participants	13 Participants	19 Participants
Race (NIH/OMB) More than one race	4 Participants	3 Participants	7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	34 Participants	28 Participants	62 Participants
Region of Enrollment United States	46 participants	44 participants	90 participants
Sex: Female, Male Female	35 Participants	33 Participants	68 Participants
Sex: Female, Male Male	11 Participants	11 Participants	22 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 46	0 / 44
serious Total, serious adverse events	0 / 46	0 / 44

Outcome results

Primary

Change of Child Body Composition

Child percent overweight difference from baseline to 6 month. The formula used to derive weight loss percentage was weight lost at 6 months divided by starting weight, multiplied by 100.