Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06521021

CHOICE to AVOID or RESIST

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Beverly Hills, California, 90211, United States

Location status: Recruiting

Location contact

Julissa Ruiz, BS

CONTACT

[email protected]

Sarah-Jeanne Salvy, PhD

CONTACT

[email protected]

Sarah-Jeanne Salvy, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • BMI between 25-45 kg/m2
  • Read, write, and speak English with acceptable visual acuity

Exclusion criteria

  • 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

Treatment and study plan

AVOID

Behavioral

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.

RESIST

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Height

    Time frame: Baseline

    Participant baseline height is self-reported in inches.

  2. Demographics

    Time frame: Baseline

    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).

  3. Drivers of preference, retention, and adherence

    Time frame: Baseline, 6 Month

    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.

  4. Weight

    Time frame: Baseline, 3 Month, 6 Month

    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.

  5. Completion Rate of Weight Self-monitoring

    Time frame: From baseline to end of treatment at 6 months

    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.

  6. Completion Rate of days with recorded dietary self-monitoring

    Time frame: From intervention start to the end of treatment at 6 months

    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.

Other outcomes

  1. Physical activity

    Time frame: From enrollment to the end of treatment at 6 months

    We will leverage data conferred by the WW program to physical activity (type, duration and intensity) via the WW mobile app or online website.

Study contacts

Contact information is provided by the study sponsor or research team.

Julissa Ruiz, BS

CONTACT

[email protected]

(310) 602-4169

Sarah-Jeanne Salvy, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • Northeastern University
  • The University of Tennessee, Knoxville
  • University of California, Riverside
  • WW International Inc

Registry information

Official study title

CHOICE to AVOID or RESIST: Evaluating Participants' Choice of Self-regulatory Strategy on Weight Management Outcomes: A Pilot Study.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2024
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.