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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01DK088380 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Variety Group | Experimental | Traditional family based weight control treatment program with components to reduce variety of high energy dense foods 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 behavioral intervention sessions. |
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| Nutrition Education Control | Experimental | 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 behavioral intervention sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Variety Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months |
| Change Parent Body Composition | Parent Body Mass Index (kg/m^2) difference from baseline to 6 months | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dietary Intake of Calories | 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. | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leonard H. Epstein, Ph.D. | SUNY Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine | Buffalo | New York | 14214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25706950 | Derived | Epstein LH, Kilanowski C, Paluch RA, Raynor H, Daniel TO. Reducing variety enhances effectiveness of family-based treatment for pediatric obesity. Eat Behav. 2015 Apr;17:140-3. doi: 10.1016/j.eatbeh.2015.02.001. Epub 2015 Feb 13. | |
| 23085682 | Derived | Epstein LH, Fletcher KD, O'Neill J, Roemmich JN, Raynor H, Bouton ME. Food characteristics, long-term habituation and energy intake. Laboratory and field studies. Appetite. 2013 Jan;60(1):40-50. doi: 10.1016/j.appet.2012.08.030. Epub 2012 Oct 22. |
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Individual participant data will not be shared under the specifics of this protocol. Outcome data will be published.
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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.
Recruitment in the Western New York area targeted obese and overweight families through pediatric offices and the local community during 2011-2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Families including an overweight child and parent.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | percentage of weight | Baseline to 6 months |
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Adverse events data were collected at baseline, each treatment session of 12 weekly, 4 by-weekly, 1 monthly and 6 months.
0 references the number of adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Two different measures were used to assess variety and calorie intake.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leonard H. Epstein, Ph.D. | SUNY Buffalo | 716-829-3400 | lhenet@buffalo.edu |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Nutrition Education Control | Behavioral | The intervention will consist of our traditional family based weight control intervention. |
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| Change in Parent Delay Discounting | 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) | Baseline to 6 months |
| Change in Child Delay Discounting | 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). | Baseline to 6 months |
| Changes in Variety 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. | Baseline to 6 months |
| 21593492 | Derived | Epstein LH, Carr KA, Cavanaugh MD, Paluch RA, Bouton ME. Long-term habituation to food in obese and nonobese women. Am J Clin Nutr. 2011 Aug;94(2):371-6. doi: 10.3945/ajcn.110.009035. Epub 2011 May 18. |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Gender (male/female) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity (NIH/OMB) parent and child | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Child percent overweight (%) | Percent overweight or percent overBMI is calculated as %OverBMI= [(BMI - BMI at 50th percentile)/BMI at 50th percentile]*100. | The measure is for the children only | Mean | Standard Deviation | Percent overweight based on BMI charts |
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| Child z-Body Mass Index | 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." | Children only | Mean | Standard Deviation | [1] z-BMI see description |
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| Parent Weight (lb.) | Parents only | Mean | Standard Deviation | pounds |
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| Parent Body Mass Index (kg/m^2) | Parents only | Mean | Standard Deviation | kg/m^2 |
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| OG001 | 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. |
|
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| Secondary | Change in Dietary Intake of Calories | 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. | Parents and children, three families did not complete the dietary measures. | Posted | Mean | Standard Deviation | calories | Baseline to 6 months |
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| Primary | Change Parent Body Composition | Parent Body Mass Index (kg/m^2) difference from baseline to 6 months | Parents | Posted | Mean | Standard Deviation | kg/m^2 | Baseline to 6 months |
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|
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| Secondary | Change in Parent Delay Discounting | 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) | Parents that completed this measure pre and post. Ten parents did not complete this post measure. | Posted | Mean | Standard Deviation | k value | Baseline to 6 months |
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|
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| Secondary | Change in Child Delay Discounting | 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). | Children that completed this measure at pre and post time points. Eleven children did not complete the post measure. | Posted | Mean | Standard Deviation | k value | Baseline to 6 months |
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| Secondary | Changes in Variety 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. | Parents and children were measured, three families did not complete the dietary measures. | Posted | Mean | Standard Deviation | food items | Baseline to 6 months |
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|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | 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. | 0 | 44 | 0 | 44 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Child change in calorie intake from 24 hr recall |
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| Parent change in calorie intake from 24 hr recall |
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| Large reinforcer |
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| Large reinforcer |
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| Child Vegetable variety from FFQ |
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| Parent Fat, Oil, Sweets variety from FFQ |
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| Parent Fruit variety from FFQ |
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| Parent Vegetable variety from FFQ |
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| Child Fats, Oils, Sweets variety from 24-HR |
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| Child Fruit variety from 24-HR |
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| Child Vegetable variety from 24-HR |
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| Parent Fats, Oils, Sweets variety from 24-HR |
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| Parent Fruit variety from 24-HR |
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| Parent Vegetable variety from 24-HR |
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