Overweight and ObesityNCT06521021
CHOICE to AVOID or RESIST
A study testing AVOID and RESIST in people with Overweight and Obesity, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This trials will formally test whether participants' active choice of self-regulatory strategies (AVOID or RESIST) leads to greater adherence to weight management strategies by comparing the CHOICE arms to the randomized arms of the parent intervention, AVOID/RESIST (IRB STUDY00001652: AVOID-RESIST). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- AVOID and RESIST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- BMI between 25-45 kg/m2
- Read, write, and speak English with acceptable visual acuity
Who cannot join
- 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 who have pacemakers or other electronic medical device implantations
- Individuals with severe cognitive delays or visual/hearing impairment
- Individuals who are unable or unwilling to complete the study assessments / measurements
- Individuals currently subscribed to a meal delivery service who are unwilling to pause their subscription for the duration of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah-Jeanne Salvy, PhD contact
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Beverly Hills, California, 90211
Julissa Ruiz, BS, julissa.ruiz@cshs.org
Sarah-Jeanne Salvy, PhD, sarah.salvy@cshs.org
About this study
Official title: CHOICE to AVOID or RESIST: Evaluating Participants' Choice of Self-regulatory Strategy on Weight Management Outcomes: A Pilot Study.
This trials will formally test whether participants' active choice of self-regulatory strategies (AVOID or RESIST) leads to greater adherence to weight management strategies by comparing the CHOICE arms to the randomized arms of the parent intervention, AVOID/RESIST (IRB STUDY00001652: AVOID-RESIST).
Read the detailed description
Since we initiated recruitment for the AVOID/RESIST trial (IRB STUDY00001652: AVOID-RESIST), we have noted that some participants have a strong initial inclination for one of the self-regulatory strategies. Some individuals have clearly expressed which strategy they believed would work for them, while others have voiced dislike or skepticism for an assigned intervention component. While attrition in the last 18 months (12.5%) is comparable to trials of similar size and scope, over 56% (n=18) of withdrawals were explicitly (n=3) or tangentially (n=15) related to intervention assignment.
This pilot study (CHOICE) seeks to leverage our ongoing R01 to test whether participants' active choice of behavior change pathways and strategies leads to better adherence, retention, and engagement. Women, and men with overweight or obesity (BMI between 25-45 kg/m2) will be enrolled in the WW digital program for 6 months. R01 participants will continue to be randomized to one of the 4 study arms: (1) WW alone, (2) WW + AVOID, (3) WW + RESIST, (4) WW + AVOID + RESIST. CHOICE participants will be asked to choose which self-regulatory strategy (AVOID or RESIST) they want to receive to promote behavior change consistent with WW recommendations.
- Conditions
- Overweight and Obesity
- Being tested
- AVOID, RESIST
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVOIDBehavioural
Behavioral: Home food environment and grocery delivery (AVOID) Participants will receive coaching (Zoom and/or email/text) to modify their home food environment and alter cues to promote healthy food choices
Behavioral: WW Participants assigned to all arms will receive of coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills.
RESISTBehavioural
Behavioral: Inhibitory control training (RESIST) Participants assigned to RESIST will receive coaching (Zoom and/or email/text) and gamified inhibitory control training.
Behavioral: WW Participants assigned to all arms will receive coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills.
| Study group | Role | What they receive |
|---|---|---|
| WW + Home modification and grocery delivery (AVOID) | Other | WW + modification of home food environment + online grocery shopping and delivery
Arm assignment is selected by participant. Receives: Behavioral: AVOID |
| WW + Inhibitory control training (RESIST) | Other | WW + daily gamified inhibitory control training
Arm assignment is selected by participant. Receives: Behavioral: RESIST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate of Follow-up Visits
We will continuously track the rate of 3-month and 6-month follow-up completion as followed: actual follow-ups completed / expected follow-ups to be completed.
Measured: 3 Month, 6 Month
Secondary outcomes (6)
Height
Participant baseline height is self-reported in inches.
Measured: Baseline
Demographics
Demographic questionnaire will be used to capture date of birth, sex and gender identity, race, ethnicity, socioeconomic status (education, household income, marital status, employment status) and household composition (e.g., multigenerational, children).
Measured: Baseline
Drivers of preference, retention, and adherence
Our quantitative analytic approach will make it possible to compare CHOICE and RANDOM study follow-up completion, adherence, and weight loss among Non-Hispanic White and among those who identify to an ethnic and/or racial minoritized group. Quantitative analyses, however, do not make it possible to contextualize drivers that may influence relative preference, retention, and adherence. Using semi-structured interviews (Appendix A), we will explore the depth of personal beliefs and experiences, cultural contexts, social dynamics, social support systems, and household factors that may influence affect participants' preferences and sustained engagement. This knowledge will inform personalized behavior change strategies that are sensitive to the diverse needs of participants' social context.
Measured: Baseline, 6 Month
Weight
Weight is measured using the Bluetooth enabled scales based on standard practices (e.g., empty pockets). Weight loss will be operationalized as the difference between weight at baseline, 3-month and 6-month.
Measured: Baseline, 3 Month, 6 Month
Completion Rate of Weight Self-monitoring
Completion rate of weight self-monitoring is defined as the frequency of weekly body weight entries recorded. The outcome is calculated as the percentage of entries with a recorded weight out of the total number of weeks in the 6-month intervention period.
Measured: From baseline to end of treatment at 6 months
Completion Rate of days with recorded dietary self-monitoring
Completion rate of the days with recorded dietary self-monitoring is calculated as the proportion of prescribed days of dietary-self monitoring successfully completed by the participant. The protocol prescribes dietary self-monitoring daily over 6 months, equivalent to about 182 days. Adherence for each participant is calculated as the number of completed days of self-monitoring logs divided by the total number of prescribed days.
Measured: From intervention start to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Jun 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Riverside, Northeastern University, WW International Inc, The University of Tennessee, Knoxville
- Responsible party
- Principal investigator, Sarah Salvy, Cedars-Sinai Medical Center
- Investigators
- Sarah Salvy, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521021
- Sponsor's protocol ID
- STUDY00003315
- Status last verified
- Feb 2026
- First submitted
- 9 Jul 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHOICE to AVOID or RESIST: Evaluating Participants' Choice of Self-regulatory Strategy on Weight Management Outcomes: A Pilot Study.
- ClinicalTrials.gov ID
- NCT06521021
- Acronym / sponsor ID
- STUDY00003315
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Riverside, Northeastern University, WW International Inc, The University of Tennessee, Knoxville
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trials will formally test whether participants' active choice of self-regulatory strategies (AVOID or RESIST) leads to greater adherence to weight management strategies by comparing the CHOICE arms to the randomized arms of the parent intervention, AVOID/RESIST (IRB STUDY00001652: AVOID-RESIST).
Detailed description
Since we initiated recruitment for the AVOID/RESIST trial (IRB STUDY00001652: AVOID-RESIST), we have noted that some participants have a strong initial inclination for one of the self-regulatory strategies. Some individuals have clearly expressed which strategy they believed would work for them, while others have voiced dislike or skepticism for an assigned intervention component. While attrition in the last 18 months (12.5%) is comparable to trials of similar size and scope, over 56% (n=18) of withdrawals were explicitly (n=3) or tangentially (n=15) related to intervention assignment.
This pilot study (CHOICE) seeks to leverage our ongoing R01 to test whether participants' active choice of behavior change pathways and strategies leads to better adherence, retention, and engagement. Women, and men with overweight or obesity (BMI between 25-45 kg/m2) will be enrolled in the WW digital program for 6 months. R01 participants will continue to be randomized to one of the 4 study arms: (1) WW alone, (2) WW + AVOID, (3) WW + RESIST, (4) WW + AVOID + RESIST. CHOICE participants will be asked to choose which self-regulatory strategy (AVOID or RESIST) they want to receive to promote behavior change consistent with WW recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WW + Home modification and grocery delivery (AVOID) | Other | Behavioral: AVOIDWW + modification of home food environment + online grocery shopping and delivery Arm assignment is selected by participant. |
| WW + Inhibitory control training (RESIST) | Other | Behavioral: RESISTWW + daily gamified inhibitory control training Arm assignment is selected by participant. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- BMI between 25-45 kg/m2
- Read, write, and speak English with acceptable visual acuity
Key exclusion criteria (7 listed)
- 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 who have pacemakers or other electronic medical device implantations
- Individuals with severe cognitive delays or visual/hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVOIDBehavioral: Home food environment and grocery delivery (AVOID) Participants will receive coaching (Zoom and/or email/text) to modify their home food environment and alter cues to promote healthy food choices Behavioral: WW Participants assigned to all arms will receive of coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills. | Behavioural | WW + Home modification and grocery delivery (AVOID) |
| RESISTBehavioral: Inhibitory control training (RESIST) Participants assigned to RESIST will receive coaching (Zoom and/or email/text) and gamified inhibitory control training. Behavioral: WW Participants assigned to all arms will receive coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills. | Behavioural | WW + Inhibitory control training (RESIST) |
Primary outcome
Completion Rate of Follow-up Visits
Time frame: 3 Month, 6 Month
We will continuously track the rate of 3-month and 6-month follow-up completion as followed: actual follow-ups completed / expected follow-ups to be completed.
6 secondary outcomes
Height
Time frame: Baseline
Demographics
Time frame: Baseline
Drivers of preference, retention, and adherence
Time frame: Baseline, 6 Month
Weight
Time frame: Baseline, 3 Month, 6 Month
Completion Rate of Weight Self-monitoring
Time frame: From baseline to end of treatment at 6 months
Completion Rate of days with recorded dietary self-monitoring
Time frame: From intervention start to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah-Jeanne Salvy, PhD contact
Sarah Salvy, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVOID and RESIST in people with Overweight and Obesity, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julissa Ruiz, BS ((310) 602-4169, julissa.ruiz@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate of Follow-up Visits (time frame: 3 Month, 6 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.