CHOICE to AVOID or RESIST

Cedars-Sinai Medical Center

Status: Not yet enrolling

Conditions: Overweight and Obesity

Treatments: Behavioral: RESIST; Behavioral: AVOID

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06521021

STUDY00003315

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

WW + Home modification and grocery delivery (AVOID)

Other group

Description:

WW + modification of home food environment + online grocery shopping and delivery Arm assignment is selected by participant.

Treatment:

Behavioral: AVOID

WW + Inhibitory control training (RESIST)

Other group

Description:

WW + daily gamified inhibitory control training Arm assignment is selected by participant.

Treatment:

Behavioral: RESIST