- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03165903
Habitual and Neurocognitive Processes in Adolescent Obesity Prevention
The study tested an intervention that used a cue-removal and implementation intentions based strategy to change habitual dietary behaviors. The intervention was evaluated using a randomized experimental design that consisted of two conditions including (1) a control condition or (2) a cue and implementation intention-based intervention. High schools (N=22) were randomly assigned to one of the two conditions. Families (N=187), with a family defined as an adolescent and one participating parent, were recruited from within the 22 schools. All of the families from each school were assigned to the same condition.
Families that were eligible for the study and that were interested in participating scheduled an appointment to complete informed consent. After written parental consent and youth assent was obtained, the participants had their height and weight measured and completed a series of questionnaires programmed on laptops. In addition, the adolescent took part in a 24 Hour Dietary Recall Assessment. The family was also informed that a second 24 Hour Dietary Recall Assessment would be administered to the adolescent over the phone in approximately 3-14 days.
Families that were from a school assigned to the control condition received an intervention on sun safety that consisted of a 10-minute meeting with a trained Health Coach, two generic newsletters, an email, and a text message. Families from a school assigned to the cue- and implementation intentions condition received an intervention on healthy snacking and the reduction of sugar sweetened beverage consumption that consisted of a 90-minute meeting with a trained Health Coach, two 20-minute phone calls, four tailored newsletters, and a series of emails and text messages. Both of these interventions were delivered over a period of 3-10 weeks depending on the self-directed pace of the participants. All participants were then asked to complete a follow-up assessment appointment three months after their original consenting appointment. Our hypotheses focused on dietary behaviors and stated that adolescents assigned to the cue-removal and implementation intentions intervention would consume significantly fewer daily servings of high fat snacks, high sugar snacks, and sugar sweetened beverages than adolescents in the control condition.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Eligibility criteria for adolescents included being English-speaking,
- between the ages of 14 and 17,
- free of major illness,
- not receiving clinical treatment for obesity,
- possessing a cell phone with text messaging capability.
Exclusion Criteria:
- failure to meet inclusion criteria
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: Cue and Implementation-Intention
Families from a school assigned to Cue and Implementation Intention-Based Intervention received an intervention targeting increased levels of healthy snacking and reduced levels of sugar sweetened beverage consumption.
|
Families from a school assigned to Cue and Implementation Intention-Based Intervention received an intervention targeting increased levels of healthy snacking and reduced levels of sugar sweetened beverage consumption.
The intervention consisted of a 90-minute meeting with a trained Health Coach, two 20-minute phone calls, 4 tailored newsletters, and a series of emails and text messages.
Cues for snacking and sweetened beverage consumption were removed or relocated and implementation-intentions were created to trigger alternative behaviors to snacking and sweetened beverage consumption in the presence of cues.
Both interventions were delivered over 3-10 weeks depending on the self-directed pace of the participants.
All participants completed a follow-up assessment 3 months after consent.
|
Inny: Control Arm
Families that were from a school assigned to Control received an intervention on sun safety that consisted of a 10-minute meeting with a trained Health Coach, 2 generic newsletters, an email, and a text message.
|
Families that were from a school assigned to Control received an intervention on sun safety that consisted of a 10-minute meeting with a trained Health Coach, 2 generic newsletters, an email, and a text message.
Both interventions were delivered over 3-10 weeks depending on the self-directed pace of the participants.
All participants completed a follow-up assessment 3 months after consent.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Sugar-Sweetened Beverage servings/day
Ramy czasowe: 3 months
|
Change in Sugar-Sweetened Beverage consumption after intervention, through survey administration
|
3 months
|
Salty Snack servings/day
Ramy czasowe: 3 months
|
Change in Salty Snack consumption after intervention, through survey administration
|
3 months
|
Sweet Snacks servings/day
Ramy czasowe: 3 months
|
Change in Sweet Snack consumption after intervention, through survey administration
|
3 months
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Kim D Reynolds, PhD, Claremont Graduate University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- U01HL097839 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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