Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain (Momentum)
7. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Charlotte Hagerman, PhD
- Telefonnummer: 14109372035
- E-post: chagerman@ori.org
Studiesteder
-
-
Oregon
-
Springfield, Oregon, Forente stater, 97477
- Rekruttering
- Oregon Research Institute Community and Evaluation Services
-
Ta kontakt med:
- Charlotte Hagerman, PhD
- Telefonnummer: 4109372035
- E-post: chagerman@ori.org
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
|
Aktiv komparator: Active Control Condition
Participants in this condition will receive minimal intervention designed to reflect "usual care" for weight loss maintenance.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
State negative affect
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
|
Calorie Tracking Frequency
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
|
Weight change
Tidsramme: End of treatment (6 months after baseline)
|
Using participants' weights from a wireless scale, their percent weight change from the beginning to the end of the study period will be calculated.
|
End of treatment (6 months after baseline)
|
|
Intervention acceptability
Tidsramme: End of treatment (6 months after baseline)
|
Intervention acceptability will be operationalized as 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mindfulness (Hypothesized intervention mediator)
Tidsramme: Mid-Treatment (3 months after baseline)
|
Participants will self-report their mindfulness using the Awareness subscale of The Philadelphia Mindfulness Scale.
The range of scores is 1-5, with higher scores indicating greater mindfulness.
|
Mid-Treatment (3 months after baseline)
|
|
Acceptance (Hypothesized intervention mediator)
Tidsramme: Mid-Treatment (3 months after baseline)
|
Participants will self-report their mindful acceptance using the Acceptance subscale of The Philadelphia Mindfulness Scale.
The range of scores is 1-5, with higher scores indicating greater mindful acceptance.
|
Mid-Treatment (3 months after baseline)
|
|
Self-compassion (Hypothesized intervention mediator)
Tidsramme: Mid-Treatment (3 months after baseline)
|
Participants will report their self-compassion using the Self-Compassion Scale Short Form.
Scores can range from 1 to 5, with higher scores indicating higher self-compassion.
|
Mid-Treatment (3 months after baseline)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. juli 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
12. juli 2026
Først innsendt som oppfylte QC-kriteriene
12. juli 2026
Først lagt ut (Faktiske)
16. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- K01HL172254 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .