CHOICE to AVOID or RESIST

ConditionOverweight and Obesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorCedars-Sinai Medical Center

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 years or older

BMI between 25-45 kg/m2

Read, write, and speak English with acceptable visual acuity

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

AVOID
Behavioral
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.
RESIST
Behavioral
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: WW + Home modification and grocery delivery (AVOID)Other 1 intervention

Group B: WW + Inhibitory control training (RESIST)Other 1 intervention

Trial outcomes

Primary outcomes

Completion 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

Secondary outcomes

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

Other outcomes

Physical activity

We will leverage data conferred by the WW program to physical activity (type, duration and intensity) via the WW mobile app or online website.

Time frame

From enrollment to the end of treatment at 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

University of California, Riverside

Collaborator

Northeastern University

Collaborator

WW International Inc

Collaborator

The University of Tennessee, Knoxville

Collaborator

Source ClinicalTrials.gov

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