CHOICE to AVOID or RESIST

NCT ID: NCT06521021

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-12-01

Brief 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).

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. Consistent with ongoing procedures, women, and men with overweight or obesity (BMI between 25-45 kg/m2) will be enrolled in the WW digital program for 12 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

WW + Home modification and grocery delivery (AVOID)

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

Arm assignment is selected by participant.

Group Type: OTHER

AVOID

Intervention Type: 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.

WW + Inhibitory control training (RESIST)

WW + daily gamified inhibitory control training

Arm assignment is selected by participant.

Group Type: OTHER

RESIST

Intervention Type: 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.

Interventions

AVOID

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.

Intervention Type: BEHAVIORAL

RESIST

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Riverside

OTHER

Sponsor Role: collaborator

Northeastern University

OTHER

Sponsor Role: collaborator

WW International Inc

INDUSTRY

Sponsor Role: collaborator

The University of Tennessee, Knoxville

OTHER

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sarah Salvy

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Salvy, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Central Contacts

Julissa Ruiz, BS

Role: CONTACT

julissa.ruiz@cshs.org

(310) 602-4169

Jessica Capaldi, MA

Role: CONTACT

Jessica.Capaldi@cshs.org

310.218.5560

Other Identifiers

STUDY00003315

Identifier Type: -

Identifier Source: org_study_id