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Parents as the Agent of Change for Childhood Obesity (PAAC)

30 listopada 2015 zaktualizowane przez: Kerri Boutelle, University of California, San Diego
The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity via parent education only, and to evaluate the cost effectiveness compared to the current gold standard treatment of parent-and-child dual education.

Przegląd badań

Szczegółowy opis

This study is a randomized clinical trial in which 150 overweight 8-12 year old children and their parent will be randomly assigned by the gender of the child to one of two conditions; a parent-only intervention or a parent + child intervention. Both treatment arms will provide behavioral treatment for childhood obesity for 5 months, and participants will be followed for 18-months post-treatment. Assessments will occur at baseline, immediately post-treatment, 6-12- and 18-months post-treatment. The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity (parent-only), and to evaluate the cost effectiveness compared to the current gold standard treatment of parent + child. Results of these studies will be utilized as evidence to recommend changes in the standard treatment for childhood obesity. This program of research is critical for exploring and developing interventions that mobilize parents to intervene with their overweight and obese children. The timing of this research is optimal given the increase in childhood obesity in the United States, and the need for disseminative intervention and prevention programs.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

152

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • California
      • La Jolla, California, Stany Zjednoczone, 92093
        • UCSD Center for Healthy Eating and Activity Research (CHEAR)

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:

  • Overweight child 8-12 years of age and above the 95th% for age and gender
  • An overweight (BMI > 25) parent willing to participate and attend all treatment meetings
  • Eligible parent who can read at a minimum of an 8th grade level
  • Family willing to commit to 5 months of treatment attendance, and follow-up for 18 months post-treatment.

Exclusion Criteria:

  • Major child psychiatric disorder diagnoses
  • Child diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet and exercise prescription are needed (self-report)
  • Family with restrictions on types of food, such as food allergies, religious, or ethnic practices that limit the foods available in the home
  • Child with physical difficulties that limit the ability to exercise
  • Child with an active eating disorder (based on EDE interview)
  • Families where children or parents are involved in swimming or weight training more than 5 hours per week
  • Major parent psychiatric disorder

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: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Parent-only Group
Treatment will be administered to parents of the overweight child. Parent-only group treatment will include all of the same skills and techniques to promote weight loss, but the information will be delivered only to the parent. Participation of the children assigned to the parent-only treatment arm will be limited to the baseline and follow-up assessments.
Parent-only group will include the same skills and techniques to promote weight loss as given to the parent + child group, but the information will be delivered only to the parent. Parent group will be compared to the parent group of the parent + child treatment arm. The focus will be on implementing skills learned to assist the child in weight management. The treatment length is set for 12 weekly meetings and bi-monthly meetings during months 4 and 5. Each group session will be 60-min including weigh-ins. Group meetings focus on behavior change, weight loss, healthy eating and activity for the overweight child and parent.
Inne nazwy:
  • Parents as the Agent of Change for Childhood Obesity (PAAC)
Aktywny komparator: Parent + child Group
The treatment for participants in the parent + child arm will be administered in two separate groups, one for the parents and one for the child.
The treatment for participants in the parent + child group will be administered in two separate groups, one for the parents and one for the child. Treatment will include the same skills and techniques to promote weight loss as given to the parent-only group, but the information will be delivered to both the parent and child. The treatment length, session schedule, treatment content and follow-up assessments are same as the parent-only group.
Inne nazwy:
  • Parents as the Agent of Change for Childhood Obesity (PAAC)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
Ramy czasowe: At post-treatment visit (after 6-month treatment)
The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment immediately following treatment.
At post-treatment visit (after 6-month treatment)
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
Ramy czasowe: At post-treatment 6-month follow-up visit
The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment at post-treatment 6-month follow-up visit.
At post-treatment 6-month follow-up visit
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
Ramy czasowe: At post-treatment 18-month follow-up visit
The primary hypothesis is that the parent-only treatment will produce a decrease in the target child's weight (BMI for age percentile/BMI_Z) that is not inferior to the parent + child treatment at post-treatment 18-month follow-up visit.
At post-treatment 18-month follow-up visit

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
Ramy czasowe: At post-treatment visit (after 6-month treatment)
We predict that the parent-only treatment will be more cost-effective than the parent + child group, as measured by calculating cost effectiveness ratios from both third party payer and limited societal perspectives at post-treatment visit (after 5-month treatment).
At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
Ramy czasowe: At post-treatment (after 6-month treatment)
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's dietary quality that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaire measures specific for child and parent.
At post-treatment (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
Ramy czasowe: At post-treatment visit (after 6-month treatment)
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's exercise behavior that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
Ramy czasowe: At post-treatment visit (after 6-month treatment)
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's quality of life consisting of physical comfort, body esteem, social life, and family relations that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
Ramy czasowe: At post-treatment visit (after 6-month treatment)
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's psychosocial measures, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
Ramy czasowe: At post-treatment visit (after 6-month treatment)
We hypothesize that the parent-only treatment will produce an effect on the parent's adherence that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by group attendance and adherence to behavior recommendations.
At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on parenting style
Ramy czasowe: At post-treatment visit (after 6-month treatment)
We hypothesize that the parent-only treatment will produce an effect on the parenting style that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
At post-treatment visit (after 6-month treatment)
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
Ramy czasowe: At post-treatment visit (after 6-month treatment)
We hypothesize that the parent-only treatment will produce parent weight loss (as measured by BMI) that is not inferior to the parent + child treatment.
At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
Ramy czasowe: At post-treatment visit (after 6-month treatment)
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Ramy czasowe: At post-treatment visit (after 6-month treatment)
Compliance will be measured by group attendance and adherence to behavior recommendations.
At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
Ramy czasowe: At post-treatment visit (after 6-month treatment)
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
Ramy czasowe: At post-treatment visit (after 6-month treatment)
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
At post-treatment visit (after 6-month treatment)
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
Ramy czasowe: At post-treatment visit (after 6-month treatment)
Changes in the target child's and parent's psychosocial functioning will be evaluated by assessing questionnaire measures specific to child and parent psychosocial functioning.
At post-treatment visit (after 6-month treatment)
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
Ramy czasowe: At post-treatment 6-month follow-up visit
We predict that the parent-only treatment will be more cost-effective than the parent + child group, as measured by calculating cost effectiveness ratios from both third party payer and limited societal perspectives at post-treatment 6-month follow-up visit.
At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
Ramy czasowe: At post-treatment 6-month follow-up visit
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's dietary quality that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaire measures specific for child and parent.
At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's dietary quality
Ramy czasowe: At post-treatment 18-month follow-up visit
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's dietary quality that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaire measures specific for child and parent.
At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
Ramy czasowe: At post-treatment 6-month follow-up visit
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's exercise behavior that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's exercise behavior
Ramy czasowe: At post-treatment 18-month follow-up visit
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's exercise behavior that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
Ramy czasowe: At post-treatment 6-month follow-up visit
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's quality of life consisting of physical comfort, body esteem, social life, and family relations that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's quality of life
Ramy czasowe: At post-treatment 18-month follow-up visit
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's quality of life consisting of physical comfort, body esteem, social life, and family relations that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
Ramy czasowe: At post-treatment 6-month follow-up visit
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's psychosocial measures, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on target child's and parent's psychosocial measures
Ramy czasowe: A post-treatment 18-month follow-up visit
We hypothesize that the parent-only treatment will produce an effect on the target child's and parent's psychosocial measures, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
A post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
Ramy czasowe: At post-treatment 6-month follow-up visit
We hypothesize that the parent-only treatment will produce an effect on the parent's adherence that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by group attendance and adherence to behavior recommendations.
At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parent's adherence
Ramy czasowe: At post-treatment 18-month follow-up visit
We hypothesize that the parent-only treatment will produce an effect on the parent's adherence that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by group attendance and adherence to behavior recommendations.
At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parenting style
Ramy czasowe: At post-treatment 6-month follow-up visit
We hypothesize that the parent-only treatment will produce an effect on the parenting style that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parenting style
Ramy czasowe: At post-treatment 18-month follow-up visit
We hypothesize that the parent-only treatment will produce an effect on the parenting style that will support weight loss, of which is not inferior to the parent + child treatment. The effect will be measured by assessing questionnaires specific for child and parent.
At post-treatment 18-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
Ramy czasowe: At post-treatment 6-month follow-up visit
We hypothesize that the parent-only treatment will produce parent weight loss (as measured by BMI) that is not inferior to the parent + child treatment.
At post-treatment 6-month follow-up visit
To compare effect of parent-only treatment versus parent + child treatment on parent's weight loss
Ramy czasowe: At post-treatment 18-month follow-up visit
We hypothesize that the parent-only treatment will produce parent weight loss (as measured by BMI) that is not inferior to the parent + child treatment.
At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
Ramy czasowe: At post-treatment 6-month follow-up visit
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating change in target child's and parent's weight
Ramy czasowe: At post-treatment 18-month follow-up visit
A decrease in BMI percentile for age for target child and a decrease in BMI for parent will be evaluated.
At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Ramy czasowe: At post-treatment 6-month follow-up visit
Compliance will be measured by group attendance and adherence to behavior recommendations.
At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating compliance
Ramy czasowe: At post-treatment 18-month follow-up visit
Compliance will be measured by group attendance and adherence to behavior recommendations.
At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
Ramy czasowe: At post-treatment 6-month follow-up visit
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatments by evaluating changes in household food environment
Ramy czasowe: At post-treatment 18-month follow-up visit
Changes in household food environment will be evaluated by assessing questionnaires specific for household food environment (Food Shelf Inventory).
At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
Ramy czasowe: At post-treatment 6-month follow-up visit
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatment by evaluating change in parenting style
Ramy czasowe: At post-treatment 18-month follow-up visit
Changes in parenting style will be evaluated by assessing questionnaires that are specific to parenting style for child and parent.
At post-treatment 18-month follow-up visit
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
Ramy czasowe: At post-treatment 6-month follow-up visit
Changes in the target child's and parent's psychosocial functioning will be evaluated by assessing questionnaire measures specific to child and parent psychosocial functioning.
At post-treatment 6-month follow-up visit
To evaluate the predictors of success in childhood obesity treatment by evaluating changes in target child's and parent's psychosocial functioning
Ramy czasowe: At post-treatment 18-month follow-up visit
Changes in the target child's and parent's psychosocial functioning will be evaluated by assessing questionnaire measures specific to child and parent psychosocial functioning.
At post-treatment 18-month follow-up visit

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Kerri Boutelle, PhD, UCSD

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

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 listopada 2010

Zakończenie podstawowe (Rzeczywisty)

1 lipca 2015

Ukończenie studiów (Rzeczywisty)

1 lipca 2015

Daty rejestracji na studia

Pierwszy przesłany

17 sierpnia 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 września 2010

Pierwszy wysłany (Oszacować)

9 września 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

2 grudnia 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 listopada 2015

Ostatnia weryfikacja

1 listopada 2015

Więcej informacji

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 .

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