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

30. november 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

152

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

8 år til 12 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andre navne:
  • Parents as the Agent of Change for Childhood Obesity (PAAC)
Aktiv 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.
Andre navne:
  • Parents as the Agent of Change for Childhood Obesity (PAAC)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the efficacy of parent-only treatment versus parent + child treatment on the body weight of the target child
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the cost-effectiveness of parent-only treatment versus parent + child treatment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Kerri Boutelle, PhD, UCSD

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2010

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. juli 2015

Datoer for studieregistrering

Først indsendt

17. august 2010

Først indsendt, der opfyldte QC-kriterier

8. september 2010

Først opslået (Skøn)

9. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. november 2015

Sidst verificeret

1. november 2015

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Parent-only Group

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