Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain (Momentum)
2026. augusztus 7. frissítette: 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.
A tanulmány áttekintése
Állapot
Toborzás
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
120
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Charlotte Hagerman, PhD
- Telefonszám: 14109372035
- E-mail: chagerman@ori.org
Tanulmányi helyek
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Oregon
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Springfield, Oregon, Egyesült Államok, 97477
- Toborzás
- Oregon Research Institute Community and Evaluation Services
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Kapcsolatba lépni:
- Charlotte Hagerman, PhD
- Telefonszám: 4109372035
- E-mail: chagerman@ori.org
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-
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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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Aktív összehasonlító: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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State negative affect
Időkeret: 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 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Mindfulness (Hypothesized intervention mediator)
Időkeret: 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)
Időkeret: Mid-Treatment (3 months after baseline)
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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.
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Mid-Treatment (3 months after baseline)
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Self-compassion (Hypothesized intervention mediator)
Időkeret: Mid-Treatment (3 months after baseline)
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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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2026. július 14.
Elsődleges befejezés (Becsült)
2027. december 31.
A tanulmány befejezése (Becsült)
2027. december 31.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. július 12.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. július 12.
Első közzététel (Tényleges)
2026. július 16.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. augusztus 11.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 7.
Utolsó ellenőrzés
2026. augusztus 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- K01HL172254 (Az Egyesült Államok NIH támogatása/szerződése)
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
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