Parents as the Agent of Change for Childhood Obesity (PAAC)
30. november 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
152
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
La Jolla, California, Forente stater, 92093
- UCSD Center for Healthy Eating and Activity Research (CHEAR)
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
8 år til 12 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
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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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Kerri Boutelle, PhD, UCSD
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Faith MS, Scanlon KS, Birch LL, Francis LA, Sherry B. Parent-child feeding strategies and their relationships to child eating and weight status. Obes Res. 2004 Nov;12(11):1711-22. doi: 10.1038/oby.2004.212.
- Epstein LH, Valoski A, Wing RR, McCurley J. Ten-year follow-up of behavioral, family-based treatment for obese children. JAMA. 1990 Nov 21;264(19):2519-23.
- Bauer KW, Nelson MC, Boutelle KN, Neumark-Sztainer D. Parental influences on adolescents' physical activity and sedentary behavior: longitudinal findings from Project EAT-II. Int J Behav Nutr Phys Act. 2008 Feb 26;5:12. doi: 10.1186/1479-5868-5-12. Erratum In: Int J Behav Nutr Phys Act. 2011;8:12.
- Epstein LH. Family-based behavioural intervention for obese children. Int J Obes Relat Metab Disord. 1996 Feb;20 Suppl 1:S14-21.
- Epstein LH, Wing RR, Steranchak L, Dickson B, Michelson J. Comparison of family-based behavior modification and nutrition education for childhood obesity. J Pediatr Psychol. 1980 Mar;5(1):25-36. doi: 10.1093/jpepsy/5.1.25. No abstract available.
- Wang G, Dietz WH. Economic burden of obesity in youths aged 6 to 17 years: 1979-1999. Pediatrics. 2002 May;109(5):E81-1. doi: 10.1542/peds.109.5.e81. Erratum In: Pediatrics 2002 Jun;109(6):1195.
- Birch LL, Davison KK. Family environmental factors influencing the developing behavioral controls of food intake and childhood overweight. Pediatr Clin North Am. 2001 Aug;48(4):893-907. doi: 10.1016/s0031-3955(05)70347-3.
- Clark HR, Goyder E, Bissell P, Blank L, Peters J. How do parents' child-feeding behaviours influence child weight? Implications for childhood obesity policy. J Public Health (Oxf). 2007 Jun;29(2):132-41. doi: 10.1093/pubmed/fdm012. Epub 2007 Apr 18.
- Kang Sim DE, Strong DR, Manzano MA, Rhee KE, Boutelle KN. Evaluation of dyadic changes of parent-child weight loss patterns during a family-based behavioral treatment for obesity. Pediatr Obes. 2020 Jun;15(6):e12622. doi: 10.1111/ijpo.12622. Epub 2020 Feb 12.
- Eichen DM, Strong DR, Rhee KE, Rock CL, Crow SJ, Epstein LH, Wilfley DE, Boutelle KN. Change in eating disorder symptoms following pediatric obesity treatment. Int J Eat Disord. 2019 Mar;52(3):299-303. doi: 10.1002/eat.23015. Epub 2019 Jan 14.
- Boutelle KN, Rhee KE, Liang J, Braden A, Douglas J, Strong D, Rock CL, Wilfley DE, Epstein LH, Crow SJ. Effect of Attendance of the Child on Body Weight, Energy Intake, and Physical Activity in Childhood Obesity Treatment: A Randomized Clinical Trial. JAMA Pediatr. 2017 Jul 1;171(7):622-628. doi: 10.1001/jamapediatrics.2017.0651.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2010
Primær fullføring (Faktiske)
1. juli 2015
Studiet fullført (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først innsendt
17. august 2010
Først innsendt som oppfylte QC-kriteriene
8. september 2010
Først lagt ut (Anslag)
9. september 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. november 2015
Sist bekreftet
1. november 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 071669
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .