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Challenge! Adolescent Obesity Prevention (Challenge)

14 sierpnia 2019 zaktualizowane przez: Maureen Black, University of Maryland, Baltimore

Challenge! in Baltimore City Middle Schools

The prevalence of overweight among adolescents (BMI-for-age %tile over the 95th percentile) has more than tripled over the past 3 decades in the US. Overweight and physical inactivity disproportionately affect low- income, female, African American adolescents.

A prior health-promotion/ obesity-prevention program for adolescents developed and tested by our group (Challenge!) showed that adolescents who received the intervention were less likely to become overweight or obese over 2 years when compared to the control group. This intervention was administered one-on-one to adolescents in their homes or community by a college-aged mentor.

Schools are an ideal setting for interventions because the effect can be far-reaching and sustainable. School-based obesity-prevention interventions have thus far shown modest results.

The purpose of this study is to evaluate the impact of a multilevel intervention that includes both the Challenge program administered in a small group format after school using mentors and teachers and a school-wide environmental change on adolescent females' body composition, diet, and physical activity. The intervention is targeted to 6th and 7th grade female students. The small group intervention is conducted over 12 weeks and includes goal setting focusing on healthy diet and physical activity, along with membership and weekly trips to the YMCA. The environmental intervention includes a Health and Activity Committee (HAC), comprised of 8th grade female students (popular opinion leaders), school personnel, parents, and community members. The HAC develops school-wide health promotion messages and activities. Parents of participating 6th and 7th grade girls provide information on family variables. The hypotheses are that females who receive the small group or environmental intervention are at less risk of weight gain (overweight) than females in the control small group condition, that females in environmental schools are at less risk of weight gain (overweight) than females in the control environmental condition, and that females who receive both the small group and environmental intervention are at the lower risk of weight gain (overweight) than females who receive only the environmental or small group intervention or neither intervention.

Przegląd badań

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

789

Faza

  • Nie dotyczy

Kontakty i lokalizacje

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

Lokalizacje studiów

    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21201
        • Baltimore City Public Schools

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

10 lat i starsze (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

For small group intervention:

  • Female Adolescent
  • Grades 6 or 7
  • No health problems that would interfere with participation in physical education classes

For environmental intervention Health and Activity Committee:

Must be one of the following:

  • 8th grade female student
  • Parent or legal guardian of any student in the school
  • School personnel
  • Adult Community member (Self-identifies as member of specified community surrounding school)

Exclusion Criteria:

For small group intervention:

  • Male
  • Outside of the grade range 6-7 at recruitment
  • Participant will be excluded if they answer no to question 1 on the screening questionnaire (unable to read and understand questions written in English)
  • Participant will be excluded if they answer yes to questions 2 or 3 on screening form (fails health screening due to medical condition preventing them from engaging in physical activity)

For environmental intervention Health and Activity Committee:

  • Inability to speak or read English
  • Inability to attend meetings

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: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Challenge! Small Group Intervention only

This group receives the Challenge! Small Group intervention consisting of curriculum related to health behavior goal setting, healthy eating, and staying active, works out with their Health Educators, and receives a year-long membership to the YMCA.

This group is in schools that were randomly assigned to NOT receive the Environmental Intervention.

The Challenge! Small Group intervention consists of curriculum related to health behavior goal setting, healthy eating, and staying active, working out with Health Educators, and receiving a year-long membership to the YMCA.
Eksperymentalny: Challenge! Small Group and Environmental Intervention

This group consists of participants who receive the Challenge! Small Group Intervention AND attend a school that is randomly assigned to receive an environmental intervention.

This group receives the Challenge! Small Group intervention consisting of curriculum related to health behavior goal setting, healthy eating, and staying active, works out with their Health Educators, and receives a year-long membership to the YMCA.

The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier.

The Challenge! Small Group intervention consists of curriculum related to health behavior goal setting, healthy eating, and staying active, working out with Health Educators, and receiving a year-long membership to the YMCA.
The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier.
Eksperymentalny: Environmental Intervention Only

This group consists of participants who do not receive the Challenge! Small Group Intervention but attend a school that is randomly assigned to receive an environmental intervention.

This group does not receive the Challenge! Small Group Intervention.

The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier.

The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier.
Brak interwencji: Control Group
This group does not receive the Challenge! Small Group intervention and is in a school that is randomly assigned to NOT have the Environmental Intervention.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Change of Body Mass Index Percentile for Age and Sex for adolescent females
Ramy czasowe: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change of Dietary Quality for adolescent females
Ramy czasowe: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Dietary quality will be assessed via the use of a Food Frequency Questionnaire.
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Maureen M Black, PhD, University of Maryland School of Medicine, Department of Pediatrics, Growth & Nutrition Division

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

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 września 2009

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2014

Ukończenie studiów (Rzeczywisty)

1 stycznia 2014

Daty rejestracji na studia

Pierwszy przesłany

2 kwietnia 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 marca 2017

Pierwszy wysłany (Rzeczywisty)

6 kwietnia 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 sierpnia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 sierpnia 2019

Ostatnia weryfikacja

1 sierpnia 2019

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • HP-00040540
  • R01HD054727 (Grant/umowa NIH USA)

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 .

Badania kliniczne na Challenge! Small Group Intervention

3
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