[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05143931":3,"trial-entities:NCT05143931":117,"trial-summary:NCT05143931":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":47,"secondary_outcomes":52,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":76,"locations":80,"central_contacts":98,"overall_officials":105,"references":108,"see_also_links":116},"NCT05143931","STUDY00001652","Avoid and Resist Strategies for Weight Management","Evaluating Environmental Control (AVOID) and Inhibitory Control (RESIST) Strategies to Improve Weight Management Outcomes","RECRUITING","2027-02-09","2026-02","2026-02-17","2022-06-06","Cedars-Sinai Medical Center","OTHER",true,"The proposed randomized controlled trial tests two self-regulatory approaches to improve intentional weight loss and diet quality in individuals with overweight or obesity: (1) an environmental control strategy (AVOID) and (2) an impulse control training strategy (RESIST).","Evidence-based weight management programs are effective when individuals are able to consistently adhere to recommendations. However, a large proportion of treatment-seeking individuals do not experience clinically significant weight loss. Innovative strategies are needed to optimize behavior change in weight management interventions. The proposed randomized controlled trial tests two self-regulatory approaches to improve intentional weight loss and diet quality in individuals with overweight or obesity: (1) an environmental control strategy (AVOID) and (2) an impulse control training strategy (RESIST). Specifically, 500 women and men (BMI between 25-45 kg\u002Fm2) will be recruited from the Cedars-Sinai Medical Center network of hospitals and clinics. All participants will be enrolled in a 12-month weight-management program (WW, formerly Weight Watchers©) focusing on diet, physical activity and mindset skills, and randomized to one of four study arms: (1) WW only, (2) WW + modification of home food environment and online grocery delivery (AVOID), (3) WW + gamified inhibitory control training (RESIST), (4) WW + AVOID + RESIST. Baseline, 6- and 12-month assessments will be completed by experienced, English and Spanish speaking study staff. Aim 1 (Outcomes). (a) Tests how AVOID and RESIST affect weight loss and waist circumference (primary) and diet quality (secondary). H1a: AVOID and\u002For RESIST (arms 2, 3, 4) will result in greater weight loss at 6-month and 12-month timepoints compared to WW alone. (b) Tests potential ripple effects of AVOID and RESIST on available household members' diet quality (primary) and weight (secondary). H1b: The investigators predict that AVOID (arms 2 and 4) will produce greater dietary changes in household members than WW alone and RESIST (arms 1 and 3). Aim 2 (Mechanisms). Tests the mechanistic pathways of AVOID and RESIST by (a) comparing longitudinal changes in inhibitory control and home food environment across study arms; and (b) whether inhibitory control and the home food environment mediate the relationships between study arms and anthropometric and dietary outcomes. H2: AVOID will produce changes in the home food environment and RESIST will operate on inhibitory control. Aim 3 (Moderators). Examines how (a) individual characteristics (age, sex, ethnicity, socioeconomic status, household composition, physical activity, baseline BMI and executive functioning), and (b) process data (frequency of grocery delivery, dining out and take out, impulse control training and WW app use) moderate the relationship between study arms and anthropometric and dietary outcomes. These considerations are important to help explain heterogeneity in intervention outcomes and to understand who benefits from AVOID and\u002For RESIST.",[19,20],"Obesity","Overweight",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},503,"ESTIMATED",[30,37,42],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Home food environment and grocery delivery (AVOID)","Participants (Arms 2 \\& 4) will receive 6 months of coaching (Zoom and\u002For email\u002Ftext) to modify their home food environment and alter cues to promote healthy food choices",[35,36],"WW + Home food modification and grocery delivery (AVOID) + Inhibitory control training (RESIST)","WW + Home modification and grocery delivery (AVOID)",{"type":31,"name":38,"description":39,"armGroupLabels":40},"Inhibitory control training (RESIST)","Participants assigned to RESIST (Arms 3 \\& 4) will receive 6 months of coaching (Zoom and\u002For email\u002Ftext) and gamified inhibitory control training.",[35,41],"WW + Inhibitory control training (RESIST)",{"type":31,"name":43,"description":44,"armGroupLabels":45},"WW","Participants assigned to all arms will receive 6 months of coaching (Zoom and\u002For email\u002Ftext) and commercially-available weight management program focusing on diet, physical activity and mindset skills.",[35,36,41,46],"WW Only",[48],{"measure":49,"description":50,"timeFrame":51},"Change in BMI from baseline to 12 months.","BMI will be calculated by aggregating participants' self-reported height in meters and weight in kilograms at baseline, 6- and 12-months.","Baseline, 6-month, 12-month",[53],{"measure":54,"description":55,"timeFrame":51},"Diet quality assessed by 24h-dietary recall","Gold standard interviewer-administered, multi-pass 24h-recalls (2 weekdays, 1 weekend day) will be used to measure diet quality. The Nutrition Data System for Research software (Nutrition Coordinating Center, University of Minnesota) is used to analyze the data. Investigators will use the 24h-recalls to assess changes in participants and household members' overall diet quality, based on adherence to the dietary guidelines for fruits and vegetables, servings of whole grains, red\u002Fprocessed meat, alcoholic beverages and food\u002Fbeverages with added sugars.","ALL","14 Years",null,{"inclusion":60,"exclusion":68,"raw_text":75},[61,62,63,64,65,66,67],"Age 18 years or older","BMI between 25-45 kg\u002Fm2","Read, write, and speak English with acceptable visual acuity","Has a household member (≥ 14 years) willing to complete three brief assessments over 12 months\\* \\*Only applies to individuals who indicate they are cohabitating with at least one eligible household member","14-years-old","Parent consent for children \\\u003C18-years-old","Willingness to complete assessments \u002F measurements",[69,70,71,72,73,74,73],"Currently enrolled in weight loss interventions or undergoing bariatric surgery","Pregnant women","Individuals for whom weight loss may be contraindicated (e.g., unstable coronary artery disease, end-stage disease, active cancer treatment, uncontrolled insulin-dependent diabetes, portal hypertension, drug\u002Falcohol abuse)","Individuals with severe cognitive delays or visual\u002Fhearing impairment","Individuals who are unable or unwilling to complete the study assessments \u002F measurements","≤ 14-years-old","Inclusion Criteria (Main participants):\n\n* Age 18 years or older\n* BMI between 25-45 kg\u002Fm2\n* Read, write, and speak English with acceptable visual acuity\n* Has a household member (≥ 14 years) willing to complete three brief assessments over 12 months\\* \\*Only applies to individuals who indicate they are cohabitating with at least one eligible household member\n\nInclusion Criteria (Household participants):\n\n* 14-years-old\n* Parent consent for children \\\u003C18-years-old\n* Willingness to complete assessments \u002F measurements\n\nExclusion Criteria (Main participants):\n\n* Currently enrolled in weight loss interventions or undergoing bariatric surgery\n* Pregnant women\n* Individuals for whom weight loss may be contraindicated (e.g., unstable coronary artery disease, end-stage disease, active cancer treatment, uncontrolled insulin-dependent diabetes, portal hypertension, drug\u002Falcohol abuse)\n* Individuals with severe cognitive delays or visual\u002Fhearing impairment\n* Individuals who are unable or unwilling to complete the study assessments \u002F measurements\n\nExclusion Criteria (Household participants):\n\n* ≤ 14-years-old\n* Individuals who are unable or unwilling to complete the study assessments \u002F measurements",[77,78,79],"CHILD","ADULT","OLDER_ADULT",[81],{"facility":13,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":95},"Los Angeles","California","90069","United States",[87,92],{"name":88,"role":89,"phone":90,"email":91},"Julissa Ruiz","CONTACT","(310) 602-4169","julissa.ruiz@cshs.org",{"name":93,"role":94},"Sarah J Salvy, PhD","PRINCIPAL_INVESTIGATOR",{"lat":96,"lon":97},34.05223,-118.24368,[99,101],{"name":100,"role":89,"phone":90,"email":91},"Julissa Ruiz, BS",{"name":102,"role":89,"phone":103,"email":104},"Jessica Capaldi, MS","310.218.5560","Jessica.Capaldi@cshs.org",[106],{"name":107,"affiliation":13,"role":94},"Sarah-Jeanne Salvy, PhD",[109,113],{"pmid":110,"type":111,"citation":112},"40738220","DERIVED","Sobolev M, Ruiz J, Diniz MA, Raynor H, Foster GD, Seitz AR, Salvy SJ. Preference for behavior change strategies in randomized controlled trials: Evidence from weight management. Contemp Clin Trials. 2025 Sep;156:108031. doi: 10.1016\u002Fj.cct.2025.108031. Epub 2025 Jul 28.",{"pmid":114,"type":111,"citation":115},"35798248","Caceres NA, Yu Q, Capaldi J, Diniz MA, Raynor H, Foster GD, Seitz AR, Salvy SJ. Evaluating environmental and inhibitory control strategies to improve outcomes in a widely available weight loss program. Contemp Clin Trials. 2022 Aug;119:106844. doi: 10.1016\u002Fj.cct.2022.106844. Epub 2022 Jul 5.",[],{"nct_id":4,"conditions":118,"biomarkers":119},[19,20],[],{"nct_id":4,"found":15,"summary":121,"prompt_version":131},{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is an interventional study with approximately 503 participants. All participants will receive the WW program and will be randomly assigned to one of four groups, which may include AVOID, RESIST, or both.","completed","Weight Management Study: AVOID and RESIST Strategies","This study is looking at new ways to help people with overweight or obesity manage their weight. It tests two approaches: AVOID, which helps you change your home food environment and get healthy groceries delivered, and RESIST, which uses coaching and games to help you control impulses around food. All participants will also join a commercial weight management program (WW). Researchers want to see how these strategies affect your body mass index (BMI) over 12 months. You might be able to join if you are 18 or older, have a BMI between 25-45 kg\u002Fm2, and can read and speak English. The study aims to enroll about 500 people, but its current recruitment status is unclear.","Your BMI will be measured at 6 months and 12 months after starting the study.",115,"You would receive 6 months of coaching via Zoom, email, or text. You will also have assessments at the start, 6 months, and 12 months. If you live with another eligible household member, they would complete three brief assessments over 12 months.","Not stated in the trial record.",[43],"v2"]