CHOICE to AVOID or RESIST: Evaluating Participants' Choice of Self-regulatory Strategy on Weight Management Outcomes: A Pilot Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Completion Rate of Follow-up Visits
Study Overview
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. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
WW + Home modification and grocery delivery (AVOID)
WW + modification of home food environment + online grocery shopping and delivery
Arm assignment is selected by participant.
Intervention: AVOID (Behavioral)
WW + Inhibitory control training (RESIST)
WW + daily gamified inhibitory control training
Arm assignment is selected by participant.
Intervention: RESIST (Behavioral)
Outcomes
Primary Outcomes
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
- Height(Baseline)
- Demographics(Baseline)
- Weight(Baseline, 3 Month, 6 Month)
- Completion Rate of Weight Self-monitoring(From baseline to end of treatment at 6 months)
- Completion Rate of days with recorded dietary self-monitoring(From intervention start to the end of treatment at 6 months)
- Drivers of preference, retention, and adherence(Baseline, 6 Month)
Investigators
Sarah Salvy
Professor of Medicine
Cedars-Sinai Medical Center