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PACE CALL: Weight Loss Study for Childhood Leukemia Survivors

25. januar 2016 opdateret af: Huang, Jeannie, M.D.

PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors

UC San Diego researchers conducted a study to develop and evaluate an internet and text message based weight loss study for childhood acute lymphoblastic leukemia (ALL) survivors. We hypothesized that those study participants randomized to the intervention will demonstrate greater reduction in BMI-z score as compared to the control group.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The PACE CALL or Fit4Life study, sponsored by the American Cancer Society , was a 4-year research project aimed at developing and testing the efficacy of a web & cell phone based weight loss program. The purpose of the intervention was to promote weight loss and management and improve physical activity, diet and sedentary behaviors among preadolescent and adolescent youth (7-18) who are survivors of childhood ALL (defined as being off therapy for at least 2 years without disease relapse). Fit4Life was based on and adapted from notable prior successful adolescent weight control interventions, and physical activity and diet behavioral promotion interventions in the preadolescent and adolescent age group. Particular sensitivity to issues experienced by cancer survivors and their families were incorporated into this newly developed intervention based on systematic cancer survivor input and feedback as well as mentor/collaborator input regarding cancer survivor research.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

38

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • La Jolla, California, Forenede Stater, 92093
        • UC San Diego

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

7 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 7 - 18 years old
  • survived childhood acute lymphoblastic leukemia (defined as being off treatment for at least 2 years)
  • greater than or equal to 85th percentile BMI-for-age and gender)
  • read and speak English
  • have a parent that reads and speaks English or Spanish
  • willingness to attend assessments
  • access to the Internet

Exclusion Criteria:

  • any comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome
  • any subject with a known disease of the liver, pancreas or small intestine that would adversely effect digestion or absorption of nutrients
  • any pulmonary, cardiovascular, orthopedic, or musculoskeletal problem that would limit ability to adhere to moderate-level physical activity recommendations
  • have a history of substance abuse or other psychiatric disorder that would impair compliance with the study protocol
  • are using any medications which alter body weight
  • are currently enrolled in another weight loss program
  • in foster care

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PACE CALL/Fit4Life

Fit4Life intervention activities:

Website: Provides weekly nutrition, physical activity, and weight loss information.

Counseling Calls: Participants and their parents will get phone calls from their Health Coach to assess progress & problems.

Health Coach Question & Answer: Participants will be assigned a Health Coach that they can contact at any time to ask questions or express any concerns.

Text & Picture Messages: Participants will receive daily text messages to help remind them of being healthy. Messages will relate to the weekly topics and general checking in questions.

Parent Materials: Parents will receive a packet of printed materials that relate to parenting skills regarding being a healthy role model for their child and healthy eating and exercise tips.
Adfærdsmæssigt: PACE CALL/Fit4Life

The Fit4Life E intervention will be designed to promote weight loss and subsequent weight loss maintenance through the adoption and maintenance of improved eating, physical activity and sedentary behaviors in at risk for overweight and overweight adolescent survivors of ALL and their parent/guardian. the Fit4Life intervention will incorporate elements of the Chronic Care Model, including frequent phone and mail interactions, an initial in-person encounter to provide encouragement and initial patient-tailored counseling for obesity management, family-centered skill development to achieve healthy behavioral modification via goal setting, self-monitoring, and problem solving.

The Fit4Life intervention includes:

Web-based weight loss program Text and Picture messages Counseling Calls Health Coach
Ingen indgriben: Control
The Control group will receive monthly mailings on basic nutrition and physical activity information.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
BMI
Tidsramme: Baseline, 4 months
To determine the impact of a weight loss intervention on BMI compared to a control group
Baseline, 4 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight Loss Behaviors
Tidsramme: Baseline, 4 months
To determine the impact of a weight loss intervention vs. a control group on self-reported behavioral measures of diet and physical activity.
Baseline, 4 months
Metabolic Blood Measures
Tidsramme: Baseline, 4 months
To determine the impact of a weight loss intervention vs. control on fasting serum insulin, fasting blood glucose, and blood lipid levels.
Baseline, 4 months
Psychosocial Mediators of Weight Loss Behaviors
Tidsramme: Baseline, 4 months
To determine the impact of a weight loss intervention vs. control on psychosocial mediators of diet and physical activity behavior changes
Baseline, 4 months
Quality of Life
Tidsramme: Baseline, 4 months
To determine the impace of a weight loss intervention vs. control on quality of life and depression.
Baseline, 4 months

Samarbejdspartnere og efterforskere

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

Sponsor

Huang, Jeannie, M.D.

Samarbejdspartnere

University of California, San Diego

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. juni 2008

Primær færdiggørelse (Faktiske)

1. juni 2013

Studieafslutning (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først indsendt

1. december 2010

Først indsendt, der opfyldte QC-kriterier

2. december 2010

Først opslået (Skøn)

3. december 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. januar 2016

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 070731

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 PACE CALL/Fit4Life

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United Arab Emirates

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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