Translating Habituation Research to Interventions for Pediatric Obesity (EAT)
1 października 2020 zaktualizowane przez: Leonard Epstein, State University of New York at Buffalo
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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
94
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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New York
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Buffalo, New York, Stany Zjednoczone, 14214
- University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
8 lat do 12 lat (Dziecko)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Variety Group
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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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.
The intervention will consist of our traditional family based weight control intervention.
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Eksperymentalny: Nutrition Education Control
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.
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The intervention will consist of our traditional family based weight control intervention.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change of Child Body Composition
Ramy czasowe: Baseline to 6 months
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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.
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Baseline to 6 months
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Change Parent Body Composition
Ramy czasowe: Baseline to 6 months
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Parent Body Mass Index (kg/m^2) difference from baseline to 6 months
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Baseline to 6 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Dietary Intake of Calories
Ramy czasowe: Baseline to 6 months
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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.
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Baseline to 6 months
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Change in Parent Delay Discounting
Ramy czasowe: Baseline to 6 months
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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)
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Baseline to 6 months
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Change in Child Delay Discounting
Ramy czasowe: Baseline to 6 months
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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).
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Baseline to 6 months
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Changes in Variety Measures
Ramy czasowe: Baseline to 6 months
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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.
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Baseline to 6 months
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Leonard H. Epstein, Ph.D., SUNY Buffalo
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
- 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.
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 października 2009
Zakończenie podstawowe (Rzeczywisty)
1 marca 2014
Ukończenie studiów (Rzeczywisty)
1 marca 2014
Daty rejestracji na studia
Pierwszy przesłany
23 września 2010
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 września 2010
Pierwszy wysłany (Oszacować)
24 września 2010
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
6 października 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
1 października 2020
Ostatnia weryfikacja
1 października 2020
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 1083316-1-52205
- 5U01DK088380 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
Individual participant data will not be shared under the specifics of this protocol.
Outcome data will be published.
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .