[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07708064":3,"trial-entities:NCT07708064":157,"trial-summary:NCT07708064":161},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":9,"sponsor_name":11,"lead_sponsor_class":12,"has_dmc":13,"brief_summary":14,"detailed_description":15,"conditions":16,"keywords":18,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":101,"sex":112,"minimum_age":113,"maximum_age":114,"healthy_volunteers":13,"eligibility_criteria":115,"std_ages":132,"locations":135,"central_contacts":151,"overall_officials":154,"references":155,"see_also_links":156},"NCT07708064","K01HL172254","Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain","RECRUITING","2027-12-31","2026-07","2026-07-16","ORI Community and Evaluation Services","OTHER",false,"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.",null,[17],"Overweight or Obesity",[19,20,21,22,23,24,25],"just-in-time adaptive interventions","weight regain","self-weighing","self-compassion","acceptance-based behavioral treatments","mindfulness","behavioral weight loss","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},120,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","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.",[39],"JITAI Condition",{"type":35,"name":41,"description":42,"armGroupLabels":43},"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.",[44],"Active Control Condition",[46,50,53,56,59,62,65,68,71,75,78,81,84,88,91,95,98],{"measure":47,"description":48,"timeFrame":49},"State negative affect","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",{"measure":51,"description":52,"timeFrame":49},"State shame","Through ecological assessment surveys, participants will respond to a single item measuring their current shame.",{"measure":54,"description":55,"timeFrame":49},"State Motivation","Through ecological assessment surveys, participants will respond to a single item measuring their current feelings of motivation.",{"measure":57,"description":58,"timeFrame":49},"State Self-Efficacy","Through ecological assessment surveys, participants will respond to a single item measuring their current self-efficacy.",{"measure":60,"description":61,"timeFrame":49},"Current confidence in the effectiveness of weight control behaviors","Through ecological assessment surveys, participants will respond to a single item measuring their current confidence in the effectiveness of weight control behaviors.",{"measure":63,"description":64,"timeFrame":49},"State self-compassion","Through ecological assessment surveys, participants will respond to a single item measuring their state self-compassion.",{"measure":66,"description":67,"timeFrame":49},"State mindfulness","Through ecological assessment surveys, participants will respond to a single item measuring their state mindfulness.",{"measure":69,"description":70,"timeFrame":49},"State acceptance","Through ecological assessment surveys, participants will respond to a single item measuring their state acceptance.",{"measure":72,"description":73,"timeFrame":74},"Self-serving interpretation of weight gain","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",{"measure":76,"description":77,"timeFrame":49},"Daily Calorie Tracking (Yes\u002FNo)","Whether participants log their calories (at least 800 calories) using a dietary tracking app that day (yes\u002Fno).",{"measure":79,"description":80,"timeFrame":49},"Daily MVPA","Minutes of moderate-to-vigorous physical activity they engage in that day, as tracked by their Fitbit band.",{"measure":82,"description":83,"timeFrame":49},"Likelihood of weighing in the following day","Likelihood that participants weigh themselves the following day on a wireless smart scale (yes\u002Fno).",{"measure":85,"description":86,"timeFrame":87},"Weight change","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)",{"measure":89,"description":90,"timeFrame":87},"Intervention acceptability","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.",{"measure":92,"description":93,"timeFrame":94},"Calorie Tracking Frequency","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)",{"measure":96,"description":97,"timeFrame":94},"Average Weekly MVPA","Average total minutes of weekly moderate-to-vigorous physical activity, as tracked by their Fitbit band, during the study period.",{"measure":99,"description":100,"timeFrame":94},"Frequency of Weighing In","Total number of days that participants weighed themselves on a wireless smart scale during the study period.",[102,106,109],{"measure":103,"description":104,"timeFrame":105},"Mindfulness (Hypothesized intervention mediator)","Participants will self-report their mindfulness using the present moment awareness subscale of the Philadelphia Mindfulness Scale.","Mid-Treatment (3 months after baseline)",{"measure":107,"description":108,"timeFrame":105},"Acceptance (Hypothesized intervention mediator)","Participants will self-report their mindful acceptance using the acceptance subscale of the Philadelphia Mindfulness Scale.",{"measure":110,"description":111,"timeFrame":105},"Self-compassion (Hypothesized intervention mediator)","Participants will report their self-compassion using the State Self-Compassion Scale.","ALL","18 Years","70 Years",{"inclusion":116,"exclusion":125,"raw_text":131},[117,118,119,120,121,122,123,124],"Ages 18-70 years","BMI of 25-50 kg\u002Fm2","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",[126,127,128,129,130],"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\u002Fweight maintenance program","Currently taking a GLP-1 medication.","Inclusion Criteria:\n\n* Ages 18-70 years\n* BMI of 25-50 kg\u002Fm2\n* Current weight is 3% lower than their highest weight in the past 3 years\n* Desire to maintain their weight or lose more\n* Ability to engage in PA, as defined as being able to walk two full city blocks without stopping\n* Smartphone and Internet access\n* Successful completion of all enrollment procedures\n* Ability to attend a workshop(s) on a Monday or Tuesday evening\n\nExclusion Criteria:\n\n* History of bariatric surgery\n* History of being diagnosed with an eating disorder\n* Currently pregnant, breastfeeding, or planning to become pregnant in the next 24 months\n* Enrolled in another formal weight loss\u002Fweight maintenance program\n* Currently taking a GLP-1 medication.",[133,134],"ADULT","OLDER_ADULT",[136],{"facility":137,"status":7,"city":138,"state":139,"zip":140,"country":141,"contacts":142,"geoPoint":148},"Oregon Research Institute Community and Evaluation Services","Springfield","Oregon","97477","United States",[143],{"name":144,"role":145,"phone":146,"email":147},"Charlotte Hagerman, PhD","CONTACT","4109372035","chagerman@ori.org",{"lat":149,"lon":150},44.04624,-123.02203,[152],{"name":144,"role":145,"phone":153,"email":147},"14109372035",[],[],[],{"nct_id":4,"conditions":158,"biomarkers":160},[159],"Overweight",[],{"nct_id":4,"found":162,"summary":163,"prompt_version":173},true,{"design":164,"status":165,"heading":166,"summary":167,"follow_up":168,"word_count":169,"commitments":170,"compensation":171,"drugs_mentioned":172},"This is an interventional study where 120 participants will be randomly assigned to one of two groups: either the JITAI program or the active control program.","completed","Smartphone App for Weight Management","This study is testing two different smartphone app programs to help people maintain their weight after losing some. One program, called JITAI, sends you short activities (like videos or reflections) right after you gain a little weight or miss a weigh-in. These activities use mindfulness and self-compassion to help you stay motivated. The other program sends weekly reminders about standard weight control tips. You might be able to join if you are 18-70 years old, have a BMI between 25-50, have recently lost at least 3% of your highest weight, and want to keep it off. The study will look at how these programs affect your feelings of sadness, shame, and motivation when you experience weight regain. The current recruitment status is unclear, and 120 people are planned to enroll.","The study measures feelings of sadness, shame, and motivation whenever participants skip a weigh-in or regain weight during the 6-month study period.",130,"For six months, participants will use a smartphone app and weigh themselves daily. They will also attend an introductory workshop.","Not stated in the trial record.",[],"v2"]