- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07708064
Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain (Momentum)
perjantai 7. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Rekrytointi
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
120
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Charlotte Hagerman, PhD
- Puhelinnumero: 14109372035
- Sähköposti: chagerman@ori.org
Opiskelupaikat
-
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Oregon
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Springfield, Oregon, Yhdysvallat, 97477
- Rekrytointi
- Oregon Research Institute Community and Evaluation Services
-
Ottaa yhteyttä:
- Charlotte Hagerman, PhD
- Puhelinnumero: 4109372035
- Sähköposti: chagerman@ori.org
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
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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.
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Active Comparator: Active Control Condition
Participants in this condition will receive minimal intervention designed to reflect "usual care" for weight loss maintenance.
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
State negative affect
Aikaikkuna: 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.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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State shame
Aikaikkuna: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current shame.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State Motivation
Aikaikkuna: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current feelings of motivation.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State Self-Efficacy
Aikaikkuna: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current self-efficacy.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Current confidence in the effectiveness of weight control behaviors
Aikaikkuna: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current confidence in the effectiveness of weight control behaviors.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State self-compassion
Aikaikkuna: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their state self-compassion.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State mindfulness
Aikaikkuna: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their state mindfulness.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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State acceptance
Aikaikkuna: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their state acceptance.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
|
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Self-serving interpretation of weight gain
Aikaikkuna: Whenever participants regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their self-serving interpretation of the weight regain.
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Whenever participants regain weight during the 6 month study period
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Daily Calorie Tracking (Yes/No)
Aikaikkuna: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Whether participants log their calories (at least 800 calories) using a dietary tracking app that day (yes/no).
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Daily MVPA
Aikaikkuna: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Minutes of moderate-to-vigorous physical activity they engage in that day, as tracked by their Fitbit band.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Likelihood of weighing in the following day
Aikaikkuna: Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Likelihood that participants weigh themselves the following day on a wireless smart scale (yes/no).
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Calorie Tracking Frequency
Aikaikkuna: 6 months (duration of study period)
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The number of days that participants logged their calories (at least 800 calories) using a dietary tracking app during the study period.
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6 months (duration of study period)
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Average Weekly MVPA
Aikaikkuna: 6 months (duration of study period)
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Average total minutes of weekly moderate-to-vigorous physical activity, as tracked by their Fitbit band, during the study period.
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6 months (duration of study period)
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Frequency of Weighing In
Aikaikkuna: 6 months (duration of study period)
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Total number of days that participants weighed themselves on a wireless smart scale during the study period.
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6 months (duration of study period)
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Weight change
Aikaikkuna: End of treatment (6 months after baseline)
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Using participants' weights from a wireless scale, their percent weight change from the beginning to the end of the study period will be calculated.
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End of treatment (6 months after baseline)
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Intervention acceptability
Aikaikkuna: End of treatment (6 months after baseline)
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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.
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End of treatment (6 months after baseline)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Mindfulness (Hypothesized intervention mediator)
Aikaikkuna: Mid-Treatment (3 months after baseline)
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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.
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Mid-Treatment (3 months after baseline)
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Acceptance (Hypothesized intervention mediator)
Aikaikkuna: 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)
|
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Self-compassion (Hypothesized intervention mediator)
Aikaikkuna: 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.
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Mid-Treatment (3 months after baseline)
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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