Trial Outcomes & Findings for Translating Habituation Research to Interventions for Pediatric Obesity (NCT NCT01208870)

NCT ID: NCT01208870

Last Updated: 2020-10-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2020-10-06

Participant Flow

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

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.

Participant milestones

Measure	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. Experimental	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.
Overall Study STARTED	46	44
Overall Study Pilot 1	20	22
Overall Study Pilot 2	26	22
Overall Study COMPLETED	44	36
Overall Study NOT COMPLETED	2	8

Reasons for withdrawal

Measure	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. Experimental	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.
Overall Study Lost to Follow-up	2	8

Baseline Characteristics

The measure is for the children only

Baseline characteristics by cohort

Measure	Experimental Group n=46 Participants 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.	Nutrition Education Control n=44 Participants 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 n=90 Participants Total of all reporting groups
Age, Customized Parent Age n=23 Experimental, n=22 Control	43.2 years STANDARD_DEVIATION 6.6 • n=46 Participants	43.0 years STANDARD_DEVIATION 6.4 • n=44 Participants	43.1 years STANDARD_DEVIATION 6.4 • n=90 Participants
Age, Customized Child Age n=23 Experimental n=22 Control	10.6 years STANDARD_DEVIATION 1.3 • n=46 Participants	10.8 years STANDARD_DEVIATION 1.4 • n=44 Participants	10.7 years STANDARD_DEVIATION 1.3 • n=90 Participants
Sex: Female, Male Female	35 Participants n=46 Participants	33 Participants n=44 Participants	68 Participants n=90 Participants
Sex: Female, Male Male	11 Participants n=46 Participants	11 Participants n=44 Participants	22 Participants n=90 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=46 Participants	2 Participants n=44 Participants	2 Participants n=90 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=46 Participants	42 Participants n=44 Participants	88 Participants n=90 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=46 Participants	0 Participants n=44 Participants	0 Participants n=90 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=46 Participants	0 Participants n=44 Participants	2 Participants n=90 Participants
Race (NIH/OMB) Asian	0 Participants n=46 Participants	0 Participants n=44 Participants	0 Participants n=90 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=46 Participants	0 Participants n=44 Participants	0 Participants n=90 Participants
Race (NIH/OMB) Black or African American	6 Participants n=46 Participants	13 Participants n=44 Participants	19 Participants n=90 Participants
Race (NIH/OMB) White	34 Participants n=46 Participants	28 Participants n=44 Participants	62 Participants n=90 Participants
Race (NIH/OMB) More than one race	4 Participants n=46 Participants	3 Participants n=44 Participants	7 Participants n=90 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=46 Participants	0 Participants n=44 Participants	0 Participants n=90 Participants
Region of Enrollment United States	46 participants n=46 Participants	44 participants n=44 Participants	90 participants n=90 Participants
Child percent overweight (%)	77.1 Percent overweight based on BMI charts STANDARD_DEVIATION 40 • n=23 Participants • The measure is for the children only	71.8 Percent overweight based on BMI charts STANDARD_DEVIATION 29.2 • n=22 Participants • The measure is for the children only	74.5 Percent overweight based on BMI charts STANDARD_DEVIATION 33.6 • n=45 Participants • The measure is for the children only
Child z-Body Mass Index	2.2 [1] z-BMI see description STANDARD_DEVIATION 0.4 • n=23 Participants • Children only	2.2 [1] z-BMI see description STANDARD_DEVIATION 0.4 • n=22 Participants • Children only	2.2 [1] z-BMI see description STANDARD_DEVIATION 0.4 • n=45 Participants • Children only
Parent Weight (lb.)	236.8 pounds STANDARD_DEVIATION 48.7 • n=23 Participants • Parents only	232.5 pounds STANDARD_DEVIATION 46.2 • n=22 Participants • Parents only	234.7 pounds STANDARD_DEVIATION 47.0 • n=45 Participants • Parents only
Parent Body Mass Index (kg/m^2)	38.9 kg/m^2 STANDARD_DEVIATION 8.2 • n=23 Participants • Parents only	37.2 kg/m^2 STANDARD_DEVIATION 6.8 • n=22 Participants • Parents only	38.1 kg/m^2 STANDARD_DEVIATION 7.5 • n=45 Participants • Parents only

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: 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.

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.

Outcome measures

Measure	Experimental Group n=21 Participants 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.	Nutrition Education Control n=18 Participants 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.
Change of Child Body Composition	-16.1 percentage of weight Standard Error 13.5	-13.3 percentage of weight Standard Error 9.6

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Parents

Parent Body Mass Index (kg/m^2) difference from baseline to 6 months

Outcome measures

Measure	Experimental Group n=23 Participants 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.	Nutrition Education Control n=18 Participants 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.
Change Parent Body Composition	-3.6 kg/m^2 Standard Deviation 2.5	-3.1 kg/m^2 Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Parents and children, three families did not complete the dietary measures.

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.

Outcome measures

Measure	Experimental Group n=40 Participants 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.	Nutrition Education Control n=34 Participants 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.
Change in Dietary Intake of Calories Child change in calorie intake from FFQ	-716.5 calories Standard Deviation 1046.6	-730.6 calories Standard Deviation 765.6
Change in Dietary Intake of Calories Parent change in calorie intake from FFQ	-916.0 calories Standard Deviation 719.8	-962.2 calories Standard Deviation 764.6
Change in Dietary Intake of Calories Child change in calorie intake from 24 hr recall	-432.4 calories Standard Deviation 396.1	-230.3 calories Standard Deviation 501.5
Change in Dietary Intake of Calories Parent change in calorie intake from 24 hr recall	-690.4 calories Standard Deviation 488.3	-501.9 calories Standard Deviation 488.0

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Parents that completed this measure pre and post. Ten parents did not complete this post measure.

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)

Outcome measures

Measure	Experimental Group n=18 Participants 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.	Nutrition Education Control n=17 Participants 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.
Change in Parent Delay Discounting Small reinforcer	0.003 k value Standard Deviation 0.023	0.032 k value Standard Deviation 0.067
Change in Parent Delay Discounting Medium reinforcer	-0.005 k value Standard Deviation 0.033	0.020 k value Standard Deviation 0.059
Change in Parent Delay Discounting Large reinforcer	-0.003 k value Standard Deviation 0.017	0.024 k value Standard Deviation 0.069

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Children that completed this measure at pre and post time points. Eleven children did not complete the post measure.

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).

Outcome measures

Measure	Experimental Group n=17 Participants 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.	Nutrition Education Control n=17 Participants 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.
Change in Child Delay Discounting Small reinforcer	0.017 k value Standard Deviation 0.071	0.006 k value Standard Deviation 0.060
Change in Child Delay Discounting Medium reinforcer	0.030 k value Standard Deviation 0.073	0.025 k value Standard Deviation 0.095
Change in Child Delay Discounting Large reinforcer	0.038 k value Standard Deviation 0.082	0.021 k value Standard Deviation 0.060

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: Parents and children were measured, three families did not complete the dietary measures.

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.

Outcome measures

Measure	Experimental Group n=40 Participants 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.	Nutrition Education Control n=34 Participants 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.
Changes in Variety Measures Child Fats, Oils, Sweets variety from FFQ	-12.5 food items Standard Deviation 16.1	-16.7 food items Standard Deviation 18.0
Changes in Variety Measures Child Fruit variety from FFQ	-6.3 food items Standard Deviation 34.7	-11.3 food items Standard Deviation 19.1
Changes in Variety Measures Child Vegetable variety from FFQ	-0.0 food items Standard Deviation 21.4	-8.0 food items Standard Deviation 16.2
Changes in Variety Measures Parent Fat, Oil, Sweets variety from FFQ	-24.3 food items Standard Deviation 17.3	-22.2 food items Standard Deviation 17.6
Changes in Variety Measures Parent Fruit variety from FFQ	16.7 food items Standard Deviation 27.1	20.3 food items Standard Deviation 27.2
Changes in Variety Measures Parent Vegetable variety from FFQ	13.5 food items Standard Deviation 19.2	16.5 food items Standard Deviation 18.5
Changes in Variety Measures Child Fats, Oils, Sweets variety from 24-HR	-9.7 food items Standard Deviation 5.9	-3.7 food items Standard Deviation 5.9
Changes in Variety Measures Child Fruit variety from 24-HR	0.5 food items Standard Deviation 1.6	0.4 food items Standard Deviation 0.8
Changes in Variety Measures Child Vegetable variety from 24-HR	0.4 food items Standard Deviation 0.8	-0.3 food items Standard Deviation 0.5
Changes in Variety Measures Parent Fats, Oils, Sweets variety from 24-HR	-11.2 food items Standard Deviation 4.4	-1.2 food items Standard Deviation 9.8
Changes in Variety Measures Parent Fruit variety from 24-HR	1.0 food items Standard Deviation 1.6	0.5 food items Standard Deviation 1.2
Changes in Variety Measures Parent Vegetable variety from 24-HR	-0.1 food items Standard Deviation 1.6	0.3 food items Standard Deviation 0.5

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nutrition Education Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leonard H. Epstein, Ph.D.

SUNY Buffalo

Phone: 716-829-3400

Email: lhenet@buffalo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place