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Active, not recruitingNCT05143931Updated Oct 6, 2026

Avoid and Resist Strategies for Weight Management

An interventional study of Home food environment and grocery delivery (AVOID) and Inhibitory control training (RESIST) in Obesity and Overweight, sponsored by Cedars-Sinai Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment

Updated Oct 6, 2026Now Active, not recruitingPrimary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
503
Allocation
Randomized
Ages
14 Years and older
Sex
All
01

Study summary

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).

Read the detailed description

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/m2) 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/or 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/or RESIST.

02

Conditions studied

  • Obesity
  • Overweight
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 503 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria (Main participants):

  • Age 18 years or older
  • BMI between 25-45 kg/m2
  • 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

Inclusion Criteria (Household participants):

  • 14-years-old
  • Parent consent for children \<18-years-old
  • Willingness to complete assessments / measurements

Exclusion Criteria (Main participants):

  • 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/alcohol abuse)
  • Individuals with severe cognitive delays or visual/hearing impairment
  • Individuals who are unable or unwilling to complete the study assessments / measurements

Exclusion Criteria (Household participants):

  • ≤ 14-years-old
  • Individuals who are unable or unwilling to complete the study assessments / measurements
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
503 participants (estimated)

Study arms

  • Active comparator
    WW Only

    WW is commercially-available weight management program focusing on diet, physical activity and mindset skills.

    Behavioral: WW

  • Experimental
    WW + Home modification and grocery delivery (AVOID)

    WW + modification of home food environment + online grocery shopping and delivery

    Behavioral: Home food environment and grocery delivery (AVOID) · Behavioral: WW

  • Experimental
    WW + Inhibitory control training (RESIST)

    WW + daily gamified inhibitory control training

    Behavioral: Inhibitory control training (RESIST) · Behavioral: WW

  • Experimental
    WW + Home food modification and grocery delivery (AVOID) + Inhibitory control training (RESIST)

    WW + modification of home food environment + online grocery shopping and delivery + daily gamified inhibitory control training

    Behavioral: Home food environment and grocery delivery (AVOID) · Behavioral: Inhibitory control training (RESIST) · Behavioral: WW

Interventions

  • BehavioralHome food environment and grocery delivery (AVOID)

    Participants (Arms 2 \& 4) will receive 6 months of coaching (Zoom and/or email/text) to modify their home food environment and alter cues to promote healthy food choices

  • BehavioralInhibitory control training (RESIST)

    Participants assigned to RESIST (Arms 3 \& 4) will receive 6 months of coaching (Zoom and/or email/text) and gamified inhibitory control training.

  • BehavioralWW

    Participants assigned to all arms will receive 6 months of coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 6-month, 12-month

Secondary outcomes

  1. 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/processed meat, alcoholic beverages and food/beverages with added sugars.

    Time frame: Baseline, 6-month, 12-month

Other outcomes

  1. Home availability of healthy and unhealthy foods and beverages

    Participants will self-report the availability of fruits and vegetables, servings of whole grains, red/processed meat, alcoholic beverages and food/beverages with added sugars in participants' homes. Responses will be scored as availability of healthy foods and beverages (e.g., fruits and vegetables), and availability of less healthy foods and beverages (e.g., processed meat, food/beverages with added sugars).

    Time frame: Baseline, 6-month, 12-month

  2. Flanker task

    Participants have 1000ms to identify which direction a central arrow is pointing. Participants complete 64 congruent and incongruent randomly mixed trials. In congruent trials flanking stimuli points in the same direction as the central stimulus while in incongruent trials flanking stimuli points in the opposite direction.

    Time frame: Baseline, 6-month, 12-month

  3. Continuous Performance Task Go/No-Go

    Participants respond to a target shape (e.g. a white five-pointed star) and withhold a response from non-target shapes. In 20% of presented trials an inhibitory response will be required.

    Time frame: Baseline, 6-month, 12-month

  4. Set-Shifting

    Participants categorize colored shapes by color or shape in three blocks. In the first two blocks, participants categorize shapes for 20 trials. In the third block, the categorization rules are randomly interleaved, and participants switch between rules. Participants have 1500ms to identify the stimulus and complete 96 trials with a 25% chance of rule-switching.

    Time frame: Baseline, 6-month, 12-month

  5. Demographics

    Participants will complete a questionnaire surveying: date of birth, sex, socioeconomic status (education level, household income, marital status, employment status), household composition (multigenerational, single, married, cohabitating, children) and race/ethnicity.

    Time frame: Baseline only

  6. Executive Functioning

    The Behavior Rating Inventory of Executive Function®- Adult Version (BRIEF-A) is a standardized measure of executive functions or self-regulation in everyday environment. The BRIEF-A assesses nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. BRIEF-A is available in English and Spanish and can be computer-administered. Baseline score on the BRIEF will be tested as moderator of the relationships between study arms and outcomes.

    Time frame: Baseline, 6-month, 12-month

  7. WW Process Data

    Interactions such as tracked food, weight and activity in WW app will be passively recorded to operationalize engagement. A higher score indicates greater engagement.

    Time frame: monthly between baseline and 12-month

  8. Grocery Delivery Process data

    Frequency of grocery delivery and dining out/take out will be recorded through participants' self-report of grocery delivery. Higher frequencies of grocery delivery indicates greater engagement.

    Time frame: monthly between baseline and 12-month

  9. PolyRules! Process data

    Frequency/duration of gamified cognitive training will be passively recorded by the PolyRules! app. Greater frequency and duration indicate greater engagement.

    Time frame: monthly between baseline and 12-month

  10. Physical activity

    The International Physical Activity Questionnaire (IPAQ) will be used to assess activity in 5 domains: job-related; transportation; housework, house maintenance, and caring for family; recreation, sport, and leisure-time physical activity; and time spent sitting. Data conferred by the WW program will also be leveraged, as participants track their activity (type, duration and intensity) via the WW mobile app or online website. Investigators will examine how engagement in exercise and daily activities moderate the relationships between study arms and outcomes.

    Time frame: Baseline, 6-month, 12-month

  11. Eating attitudes

    The Dutch Eating Behavior Questionnaire (DEBQ) will be used to assess participants' approach to food and eating along three dimensions: emotional, external and restricted eating. There is a high degree of stability for each of these three eating behavior scales. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.

    Time frame: Baseline, 6-month, 12-month

  12. Food Security Questionnaire

    The Food Security Questionnaire will be used to evaluate the availability of nutritious and safe foods for participants and their households at all times. The questionnaire will assess the household's ability to meet their food needs and will determine their placement on a food security continuum based on their responses to a series of questions. Researchers will analyze how food security impacts the relationships between different study arms and the outcomes.

    Time frame: Baseline only

  13. Changes in Health and Lifestyle.

    Changes in health, medication, diet, and exercise among participants will be assessed via routine questionnaires administered at specific study time points (e.g., 6 and 12 months). The study team will monitor reported changes on an ongoing basis. Any data indicating potential new exclusion criteria (e.g., a diagnosis of cancer or other serious conditions) will be reviewed on a case-by-case basis. If the data meet the criteria for New Reportable Information (NRI), such as adverse events or single-subject exemptions, the appropriate reporting procedures will be followed according to IRB guidelines.

    Time frame: 6-month, 12-month

  14. Participant Experience Interview

    Main participants will be asked to complete a brief semi-structured participant experience interview at 6 months and at the conclusion of their intervention (either at withdrawal or 12-months). The interview will be conducted online via Zoom or MS Teams and last between 10-15 minutes. The questions asked will vary depending on the intervention arm.

    Time frame: withdrawal or 6-month and 12-month

07

Study locations

1 site
  • Cedars-Sinai Medical Center
    Los Angeles, California 90069, United States
08

References and documents

Publications

  • 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/j.cct.2025.108031. Epub 2025 Jul 28. PubMed 40738220 ↗
  • 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/j.cct.2022.106844. Epub 2022 Jul 5. PubMed 35798248 ↗

Study documents

  • Informed consent form · Feb 17, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 6, 2026
Primary completion
Dec 1, 2026→Feb 2027
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Recruiting→Active, not recruiting
    Primary completion Dec 1, 2026→Feb 2027
    + 4 other changes: verification date, contact details, site details and documents

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05143931
Lead sponsor
Cedars-Sinai Medical Center
Collaborators
University of California, Riverside, WW International Inc, The University of Tennessee, Knoxville, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northeastern University
Responsible party
Sarah Salvy (Professor, Department of Medicine, Cedars-Sinai Medical Center) — Principal investigator
First posted
Dec 3, 2021
Start date
Jun 6, 2022
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Oct 6, 2026

Study contacts

Sarah-Jeanne Salvy, PhD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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