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).
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
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.
Cedars-Sinai Medical Center
Beverly Hills, California, United States
RECRUITINGCompletion Rate of Follow-up Visits
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.
Time frame: 3 Month, 6 Month
Height
Participant baseline height is self-reported in inches.
Time frame: 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).
Time frame: 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.
Time frame: 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, 3-month and 6-month.
Time frame: Baseline, 3 Month, 6 Month
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Completion Rate of Weight Self-monitoring
Completion rate of weight self-monitoring is defined as the frequency of weekly body weight entries recorded. The outcome is calculated as the percentage of entries with a recorded weight out of the total number of weeks in the 6-month intervention period.
Time frame: From baseline to end of treatment at 6 months
Completion Rate of days with recorded dietary self-monitoring
Completion rate of the days with recorded dietary self-monitoring is calculated as the proportion of prescribed days of dietary-self monitoring successfully completed by the participant. The protocol prescribes dietary self-monitoring daily over 6 months, equivalent to about 182 days. Adherence for each participant is calculated as the number of completed days of self-monitoring logs divided by the total number of prescribed days.
Time frame: From intervention start to the end of treatment at 6 months