Clinical trial NCT06521021: CHOICE to AVOID or RESIST
Official title: CHOICE to AVOID or RESIST: Evaluating Participants' Choice of Self-regulatory Strategy on Weight Management Outcomes: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, Riverside
name: Northeastern University
name: WW International Inc
name: The University of Tennessee, Knoxville
First posted: 2024-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Follow-up Completion
timeFrame: Baseline, 6 Month, 12 Month
Secondary outcomes:
measure: Height
timeFrame: Baseline
measure: Demographics
timeFrame: Baseline
measure: Drivers of preference, retention, and adherence
timeFrame: Baseline, 6 Month, 12 Month
measure: Weight
timeFrame: Baseline, 6 Month, 12 Month
Other outcomes:
measure: Dietary intake and physical activity
timeFrame: Baseline, 6 Month, 12 Month
Locations:
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Sarah Salvy, PhD
role: PRINCIPAL_INVESTIGATOR
References: