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Translating Habituation Research to Interventions for Pediatric Obesity (EAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01208870
Recruitment Status : Completed
First Posted : September 24, 2010
Results First Posted : October 2, 2017
Last Update Posted : October 6, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Leonard Epstein, State University of New York at Buffalo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Pediatric Obesity
Habituation
Interventions Behavioral: Variety Group
Behavioral: Nutrition Education Control
Enrollment 94
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.
Arm/Group Title Experimental Group Nutrition Education Control
Hide Arm/Group Description

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. Experimental

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.

Period Title: Overall Study
Started 46 [1] 44 [2]
Pilot 1 20 22
Pilot 2 26 22
Completed 44 36
Not Completed 2 8
Reason Not Completed
Lost to Follow-up             2             8
[1]
The same group was run as Pilot 1 Spring 2012 and Pilot 2 Summer 2013
[2]
The same group was run as Pilot 1 Spring 2012 and Pilot 2 Summer 2013.
Arm/Group Title Experimental Group Nutrition Education Control Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 46 44 90
Hide Baseline Analysis Population Description
Families including an overweight child and parent.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Parent Age n=23 Experimental, n=22 Control Number Analyzed 46 participants 44 participants 90 participants
43.2  (6.6) 43.0  (6.4) 43.1  (6.4)
Child Age n=23 Experimental n=22 Control Number Analyzed 46 participants 44 participants 90 participants
10.6  (1.3) 10.8  (1.4) 10.7  (1.3)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
Female
35
  76.1%
33
  75.0%
68
  75.6%
Male
11
  23.9%
11
  25.0%
22
  24.4%
[1]
Measure Description: Gender (male/female)
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
Hispanic or Latino
0
   0.0%
2
   4.5%
2
   2.2%
Not Hispanic or Latino
46
 100.0%
42
  95.5%
88
  97.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Ethnicity (NIH/OMB) parent and child
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
American Indian or Alaska Native
2
   4.3%
0
   0.0%
2
   2.2%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  13.0%
13
  29.5%
19
  21.1%
White
34
  73.9%
28
  63.6%
62
  68.9%
More than one race
4
   8.7%
3
   6.8%
7
   7.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 44 participants 90 participants
46 44 90
Child percent overweight (%)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Percent overweight based on BMI charts
Number Analyzed 23 participants 22 participants 45 participants
77.1  (40) 71.8  (29.2) 74.5  (33.6)
[1]
Measure Description: Percent overweight or percent overBMI is calculated as %OverBMI= [(BMI - BMI at 50th percentile)/BMI at 50th percentile]*100.
[2]
Measure Analysis Population Description: The measure is for the children only
Child z-Body Mass Index   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  [1] z-BMI see description
Number Analyzed 23 participants 22 participants 45 participants
2.2  (0.4) 2.2  (0.4) 2.2  (0.4)
[1]
Measure Description: The formula for calculating LMS z-BMI scores based on age and sex is LMS method z-BMI = ((BMI/M L) - 1))/(L*S), where BMI = an individual's BMI, M =the median BMI for age and gender, L = power in the Box-Cox transformation for age and gender, and S =standard deviation for age and gender (Kuczmarski et al., 2002). A reference is Z-score of 0 is equal to the mean. Negative z-scores indicate values lower than the average and positive numbers indicate values higher than the average."
[2]
Measure Analysis Population Description: Children only
Parent Weight (lb.)   [1] 
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 23 participants 22 participants 45 participants
236.8  (48.7) 232.5  (46.2) 234.7  (47.0)
[1]
Measure Analysis Population Description: Parents only
Parent Body Mass Index (kg/m^2)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 23 participants 22 participants 45 participants
38.9  (8.2) 37.2  (6.8) 38.1  (7.5)
[1]
Measure Analysis Population Description: Parents only
1.Primary Outcome
Title Change of Child Body Composition
Hide Description 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.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Children that completed the reported measures. Two children did not complete the body composition measures from the experimental groups and four children from the control group did not complete this measure.
Arm/Group Title Experimental Group Nutrition Education Control
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 21 18
Mean (Standard Error)
Unit of Measure: percentage of weight
-16.1  (13.5) -13.3  (9.6)
2.Primary Outcome
Title Change Parent Body Composition
Hide Description Parent Body Mass Index (kg/m^2) difference from baseline to 6 months
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Parents
Arm/Group Title Experimental Group Nutrition Education Control
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 23 18
Mean (Standard Deviation)
Unit of Measure: kg/m^2
-3.6  (2.5) -3.1  (2.4)
3.Secondary Outcome
Title Change in Dietary Intake of Calories
Hide Description 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.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Parents and children, three families did not complete the dietary measures.
Arm/Group Title Experimental Group Nutrition Education Control
Hide Arm/Group Description:

Traditional family based weight control treatment program with components from habituation theory incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 sessions.

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.

Traditional family based weight control treatment program, without components from habituation theory incorporated into the treatment. Families meet weekly for 12 weeks, then by-weekly for 1 month and 1 monthly session for a total of 15 sessions.

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.

Overall Number of Participants Analyzed 40 34
Mean (Standard Deviation)
Unit of Measure: calories
Child change in calorie intake from FFQ -716.5  (1046.6) -730.6  (765.6)
Parent change in calorie intake from FFQ -916.0  (719.8) -962.2  (764.6)
Child change in calorie intake from 24 hr recall -432.4  (396.1) -230.3  (501.5)
Parent change in calorie intake from 24 hr recall -690.4  (488.3) -501.9  (488.0)
4.Secondary Outcome
Title Change in Parent Delay Discounting
Hide Description 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)
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Parents that completed this measure pre and post. Ten parents did not complete this post measure.
Arm/Group Title Experimental Group Nutrition Education Control
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: k value
Small reinforcer 0.003  (0.023) 0.032  (0.067)
Medium reinforcer -0.005  (0.033) 0.020  (0.059)
Large reinforcer -0.003  (0.017) 0.024  (0.069)
5.Secondary Outcome
Title Change in Child Delay Discounting
Hide Description 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).
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Children that completed this measure at pre and post time points. Eleven children did not complete the post measure.
Arm/Group Title Experimental Group Nutrition Education Control
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: k value
Small reinforcer 0.017  (0.071) 0.006  (0.060)
Medium reinforcer 0.030  (0.073) 0.025  (0.095)
Large reinforcer 0.038  (0.082) 0.021  (0.060)
6.Secondary Outcome
Title Changes in Variety Measures
Hide Description 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.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Parents and children were measured, three families did not complete the dietary measures.
Arm/Group Title Experimental Group Nutrition Education Control
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 40 34
Mean (Standard Deviation)
Unit of Measure: food items
Child Fats, Oils, Sweets variety from FFQ -12.5  (16.1) -16.7  (18.0)
Child Fruit variety from FFQ -6.3  (34.7) -11.3  (19.1)
Child Vegetable variety from FFQ -0.0  (21.4) -8.0  (16.2)
Parent Fat, Oil, Sweets variety from FFQ -24.3  (17.3) -22.2  (17.6)
Parent Fruit variety from FFQ 16.7  (27.1) 20.3  (27.2)
Parent Vegetable variety from FFQ 13.5  (19.2) 16.5  (18.5)
Child Fats, Oils, Sweets variety from 24-HR -9.7  (5.9) -3.7  (5.9)
Child Fruit variety from 24-HR 0.5  (1.6) 0.4  (0.8)
Child Vegetable variety from 24-HR 0.4  (0.8) -0.3  (0.5)
Parent Fats, Oils, Sweets variety from 24-HR -11.2  (4.4) -1.2  (9.8)
Parent Fruit variety from 24-HR 1.0  (1.6) 0.5  (1.2)
Parent Vegetable variety from 24-HR -0.1  (1.6) 0.3  (0.5)
Time Frame Adverse events data were collected at baseline, each treatment session of 12 weekly, 4 by-weekly, 1 monthly and 6 months.
Adverse Event Reporting Description 0 references the number of adverse events
 
Arm/Group Title Experimental Group Nutrition Education Control
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Experimental Group Nutrition Education Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Experimental Group Nutrition Education Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/44 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental Group Nutrition Education Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/44 (0.00%) 
Two different measures were used to assess variety and calorie intake.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Leonard H. Epstein, Ph.D.
Organization: SUNY Buffalo
Phone: 716-829-3400
EMail: lhenet@buffalo.edu
Layout table for additonal information
Responsible Party: Leonard Epstein, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01208870    
Other Study ID Numbers: 1083316-1-52205
5U01DK088380 ( U.S. NIH Grant/Contract )
First Submitted: September 23, 2010
First Posted: September 24, 2010
Results First Submitted: January 8, 2016
Results First Posted: October 2, 2017
Last Update Posted: October 6, 2020