CHOICE to AVOID or RESIST

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: AVOID; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julissa Ruiz, BS; Phone Number: (310) 602-4169; Email: julissa.ruiz@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: WW + Home modification and grocery delivery (AVOID); WW + modification of home food environment + online grocery shopping and delivery Arm assignment is selected by participant.	Behavioral: 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.
Other: WW + Inhibitory control training (RESIST); WW + daily gamified inhibitory control training Arm assignment is selected by participant.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow-up Completion	We will continuously track the rate of 6-month follow-up completion as followed: actual follow-ups completed / expected follow-ups to be completed.	Baseline, 6 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Participant baseline height is self-reported in inches.	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).	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.	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 and 6mo.	Baseline, 6 Month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intake and physical activity	We will leverage data conferred by the WW program to capture dietary intake and physical activity (type, duration and intensity) via the WW mobile app or online website.	Baseline, 6 Month

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: The University of Tennessee, Knoxville; Northeastern University; University of California, Riverside; WW International Inc
• Investigators: Principal Investigator: Sarah Salvy, PhD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: STUDY00003315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No