Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain (Momentum)

12. července 2026 aktualizováno: ORI Community and Evaluation Services
This trial will test the effectiveness of a weight loss maintenance intervention designed to help participants respond more adaptively to weight regain. Participants will be randomly assigned to one of two conditions. In one condition, participants will receive brief exercises (e.g., written reflections, videos) sent to through a smartphone app immediately after they regain weight or miss a weigh-in. These exercises will use mindfulness, acceptance, and self-compassion strategies to help participants stay motivated for their long term goals, even when weight regain feels demoralizing. In the comparison condition, participants will receive weekly reminders of standard weight control strategies strategies.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

120

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Charlotte Hagerman, PhD
  • Telefonní číslo: 14109372035
  • E-mail: chagerman@ori.org

Studijní místa

  • Spojené státy
    • Oregon
      • Springfield, Oregon, Spojené státy, 97477
        • Nábor
        • Oregon Research Institute Community and Evaluation Services
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Ages 18-70 years
  • BMI of 25-50 kg/m2
  • Current weight is 3% lower than their highest weight in the past 3 years
  • Desire to maintain their weight or lose more
  • Ability to engage in PA, as defined as being able to walk two full city blocks without stopping
  • Smartphone and Internet access
  • Successful completion of all enrollment procedures
  • Ability to attend a workshop(s) on a Monday or Tuesday evening

Exclusion Criteria:

  • History of bariatric surgery
  • History of being diagnosed with an eating disorder
  • Currently pregnant, breastfeeding, or planning to become pregnant in the next 24 months
  • Enrolled in another formal weight loss/weight maintenance program
  • Currently taking a GLP-1 medication.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: JITAI Condition
Participants in this condition will receive a 6-month weight loss maintenance intervention that uses mindfulness, acceptance, and self-compassion strategies to respond to weight regain.
Behaviorální: JITAI Combined with psychological intervention
For six months, participants will receive a just-in-time adaptive interventions via a smartphone app immediately after they gain weight or they skip a weigh-in (according to a specific algorithm). Interventions will engage participants in mindfulness, acceptance, and self-compassion-based (MASC) strategies through different modalities (e.g., writing exercises, videos, audio reflections). They will take approximately 1-10 minutes. Participants will also attend an introductory workshop, during which they will receive the instructions weigh daily, learn the importance of quickly responding to weight regain, and be introduced to MASC strategies. They will also attend two booster workshops during the 6-month period.
Aktivní komparátor: Active Control Condition
Participants in this condition will receive minimal intervention designed to reflect "usual care" for weight loss maintenance.
Behaviorální: Active Control
For six months, participants will receive weekly, automated messages via a smartphone app with reminders of standard behavioral weight control principles. Participants will attend an introductory workshop, during which they will receive instructions to weigh daily and learn the importance of responding to weight regain.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
State negative affect
Časové okno: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current negative affect.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
State shame
Časové okno: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current shame.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
State Motivation
Časové okno: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current feelings of motivation.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
State Self-Efficacy
Časové okno: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current self-efficacy.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
Current confidence in the effectiveness of weight control behaviors
Časové okno: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current confidence in the effectiveness of weight control behaviors.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
State self-compassion
Časové okno: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their state self-compassion.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
State mindfulness
Časové okno: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their state mindfulness.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
State acceptance
Časové okno: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their state acceptance.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
Self-serving interpretation of weight gain
Časové okno: Whenever participants regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their self-serving interpretation of the weight regain.
Whenever participants regain weight during the 6 month study period
Daily Calorie Tracking (Yes/No)
Časové okno: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Whether participants log their calories (at least 800 calories) using a dietary tracking app that day (yes/no).
Whenever participants skip a weigh-in or regain weight during the 6 month study period
Daily MVPA
Časové okno: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Minutes of moderate-to-vigorous physical activity they engage in that day, as tracked by their Fitbit band.
Whenever participants skip a weigh-in or regain weight during the 6 month study period
Likelihood of weighing in the following day
Časové okno: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Likelihood that participants weigh themselves the following day on a wireless smart scale (yes/no).
Whenever participants skip a weigh-in or regain weight during the 6 month study period
Weight change
Časové okno: End of treatment (6 months after baseline)
Using participants' weights from a wireless scale, we will calculate their percent weight change from the beginning to the end of the study period.
End of treatment (6 months after baseline)
Intervention acceptability
Časové okno: End of treatment (6 months after baseline)
We will record the percent of participants who indicate that they are "satisfied" or "very satisfied" with the program on an anonymous survey that they complete during their individual interview.
End of treatment (6 months after baseline)
Calorie Tracking Frequency
Časové okno: 6 months (duration of study period)
The number of days that participants logged their calories (at least 800 calories) using a dietary tracking app during the study period.
6 months (duration of study period)
Average Weekly MVPA
Časové okno: 6 months (duration of study period)
Average total minutes of weekly moderate-to-vigorous physical activity, as tracked by their Fitbit band, during the study period.
6 months (duration of study period)
Frequency of Weighing In
Časové okno: 6 months (duration of study period)
Total number of days that participants weighed themselves on a wireless smart scale during the study period.
6 months (duration of study period)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mindfulness (Hypothesized intervention mediator)
Časové okno: Mid-Treatment (3 months after baseline)
Participants will self-report their mindfulness using the present moment awareness subscale of the Philadelphia Mindfulness Scale.
Mid-Treatment (3 months after baseline)
Acceptance (Hypothesized intervention mediator)
Časové okno: Mid-Treatment (3 months after baseline)
Participants will self-report their mindful acceptance using the acceptance subscale of the Philadelphia Mindfulness Scale.
Mid-Treatment (3 months after baseline)
Self-compassion (Hypothesized intervention mediator)
Časové okno: Mid-Treatment (3 months after baseline)
Participants will report their self-compassion using the State Self-Compassion Scale.
Mid-Treatment (3 months after baseline)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

ORI Community and Evaluation Services

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

12. července 2026

První předloženo, které splnilo kritéria kontroly kvality

12. července 2026

První zveřejněno (Aktuální)

16. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • K01HL172254 (Grant/smlouva NIH USA)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Nadváha nebo obezita

Klinické studie na JITAI Combined with psychological intervention

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Dominican Republic

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
Předplatit