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Behavior Change Family Counseling to Reduce Rate of Weight Gain in At-Risk Children

6 april 2015 uppdaterad av: Children's Hospital of Philadelphia

Primary Care Obesity Prevention: One or Multiple Targets

This study will train primary care providers to counsel families on behavior change that is aimed at reducing the rate of weight gain in at-risk children.

Studieöversikt

Detaljerad beskrivning

BACKGROUND:

In addition to family, school, and community, primary care is a promising setting for childhood obesity prevention. However, most pediatric primary care providers are not trained to deliver behavior modification interventions and, according to preliminary data, are less likely to address obesity prevention when they perceive insufficient time during well-care visits.

DESIGN NARRATIVE:

This is a controlled study of obesity prevention, with group randomization of two standardized 12-month intervention strategies at the practice level. The intervention strategies are based on the behavioral economics theory and will be delivered by primary care providers after training in behavior modification. The first strategy will target change in multiple behaviors, while the second strategy will target only one behavior (beverage consumption). These two interventions will be compared to an active control intervention that is unrelated to weight (bullying prevention). Six to seven primary care practices will be randomized to each arm with 21 patients per practice, for a total of 17 practices and 350 patients. The primary aim is to demonstrate that either obesity prevention intervention will result in less body mass index (BMI) increase (adjusted using z-score) in children age 8 to 12 years who are at risk for overweight (BMI 50th-95th percentile), as compared to a control intervention. The study also hypothesizes that the multiple-behavior intervention, the single-behavior intervention, or both will result in less adjusted BMI increase than the control intervention at 24 months post-randomization, with no a priori assumption in differences between the two obesity prevention strategies. Blood pressure, insulin resistance, dyslipidemia, and oral health status will be secondary outcomes. Intermediate behavioral outcomes and process data will be collected.

Studietyp

Interventionell

Inskrivning (Faktisk)

158

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • The Children's Hospital of Philadelphia

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

8 år till 12 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Sought care at the participating practices at least once in the 3 years prior to study entry
  • Children "at risk for overweight" at their last clinical visit (according to the Center for Disease Control and Prevention [CDC] definition of a BMI at or above the 50th percentile, but less than the 95th percentile)
  • Children who consume at least 28 oz of sweetened beverages per week (i.e., an average of 4 oz per day) as assessed during the telephone screening by selected components of a validated food frequency questionnaire
  • The following conditions will be acceptable if they have been well controlled in the 3 months prior to study entry: hypertension, dyslipidemia, sleep apnea, asthma, and insulin resistance without diabetes

Exclusion Criteria:

  • Developmental delay requiring special education
  • Depression
  • Psychosis
  • Eating disorder
  • Significant orthopedic problems interfering with physical activity
  • Diabetes
  • Any significant chronic condition potentially interfering with nutrition or physical activity
  • Treated with a drug known to affect weight gain
  • Measured BMI z-score at first visit higher than +2.0 Standard Deviations (97.7th percentile)
  • Families who are uninterested or unable to participate
  • Home-schooled

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Healthy Lifestyle (Active Intervention)
Parents and children in this program which will participate in a series of consultations and activities focused on multiple healthy interventions including healthy eating, drinking, and physical activity. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on healthy eating, drinking, and physical activity. In addition, your child will receive information on developing healthy interpersonal and social skills.
Focused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight.
Övrig: Healthy Drinks (Active Intervention)
Parents and children in this program will participate in a series of consultations and activities focused on a single intervention, the effects of beverage choices on diet, general health and teeth health. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on beverages and health. In addition, your child will receive information on healthy nutrition, physical activity, and interpersonal and social skills.
Focused on changing beverage choices which may have a significant impact on weight.
Andra namn:
  • Focused on changing beverage choices with the goal
Övrig: Social and Leadership Skills (Control Intervention)
Parents and children in this program will participate in a series of consultations that are designed to help your child learn strategies to make and keep friends, to express feelings appropriately, and to successfully decrease conflicts that often occur at school among children. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on these friendship making strategies. In addition, your child will receive information on healthy nutrition and physical activity. There is o intervention with regards to healthy weight.
Focused on standard intervention strategies unrelated to weight including bullying prevention.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Changes in BMI z-score
Tidsram: Measured at Month 12
Measured at Month 12

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Stephen Leff, PhD, Children's Hospital of Philadelphia

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2006

Primärt slutförande (Faktisk)

1 maj 2011

Avslutad studie (Faktisk)

1 februari 2015

Studieregistreringsdatum

Först inskickad

17 oktober 2005

Först inskickad som uppfyllde QC-kriterierna

17 oktober 2005

Första postat (Uppskatta)

19 oktober 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

7 april 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 april 2015

Senast verifierad

1 april 2015

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2005-7-4442
  • R01HL084056 (U.S.S. NIH-anslag/kontrakt)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Hjärtsjukdom

Kliniska prövningar på Multiple behavior interventions

3
Prenumerera