Avoid and Resist Strategies for Weight Management

NCT ID: NCT05143931

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

503 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2027-02-09

Brief Summary

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The proposed randomized controlled trial tests two self-regulatory approaches to improve intentional weight loss and diet quality in individuals with overweight or obesity: (1) an environmental control strategy (AVOID) and (2) an impulse control training strategy (RESIST).

Detailed Description

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Evidence-based weight management programs are effective when individuals are able to consistently adhere to recommendations. However, a large proportion of treatment-seeking individuals do not experience clinically significant weight loss. Innovative strategies are needed to optimize behavior change in weight management interventions. The proposed randomized controlled trial tests two self-regulatory approaches to improve intentional weight loss and diet quality in individuals with overweight or obesity: (1) an environmental control strategy (AVOID) and (2) an impulse control training strategy (RESIST). Specifically, 500 women and men (BMI between 25-45 kg/m2) will be recruited from the Cedars-Sinai Medical Center network of hospitals and clinics. All participants will be enrolled in a 12-month weight-management program (WW, formerly Weight Watchers©) focusing on diet, physical activity and mindset skills, and randomized to one of four study arms: (1) WW only, (2) WW + modification of home food environment and online grocery delivery (AVOID), (3) WW + gamified inhibitory control training (RESIST), (4) WW + AVOID + RESIST. Baseline, 6- and 12-month assessments will be completed by experienced, English and Spanish speaking study staff. Aim 1 (Outcomes). (a) Tests how AVOID and RESIST affect weight loss and waist circumference (primary) and diet quality (secondary). H1a: AVOID and/or RESIST (arms 2, 3, 4) will result in greater weight loss at 6-month and 12-month timepoints compared to WW alone. (b) Tests potential ripple effects of AVOID and RESIST on available household members' diet quality (primary) and weight (secondary). H1b: The investigators predict that AVOID (arms 2 and 4) will produce greater dietary changes in household members than WW alone and RESIST (arms 1 and 3). Aim 2 (Mechanisms). Tests the mechanistic pathways of AVOID and RESIST by (a) comparing longitudinal changes in inhibitory control and home food environment across study arms; and (b) whether inhibitory control and the home food environment mediate the relationships between study arms and anthropometric and dietary outcomes. H2: AVOID will produce changes in the home food environment and RESIST will operate on inhibitory control. Aim 3 (Moderators). Examines how (a) individual characteristics (age, sex, ethnicity, socioeconomic status, household composition, physical activity, baseline BMI and executive functioning), and (b) process data (frequency of grocery delivery, dining out and take out, impulse control training and WW app use) moderate the relationship between study arms and anthropometric and dietary outcomes. These considerations are important to help explain heterogeneity in intervention outcomes and to understand who benefits from AVOID and/or RESIST.

Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single-site, prospective, four-parallel-arm, randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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WW Only

WW is commercially-available weight management program focusing on diet, physical activity and mindset skills.

Group Type ACTIVE_COMPARATOR

WW

Intervention Type BEHAVIORAL

Participants assigned to all arms will receive 6 months of coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills.

WW + Home modification and grocery delivery (AVOID)

WW + modification of home food environment + online grocery shopping and delivery

Group Type EXPERIMENTAL

Home food environment and grocery delivery (AVOID)

Intervention Type BEHAVIORAL

Participants (Arms 2 \& 4) will receive 6 months of coaching (Zoom and/or email/text) to modify their home food environment and alter cues to promote healthy food choices

WW

Intervention Type BEHAVIORAL

Participants assigned to all arms will receive 6 months of coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills.

WW + Inhibitory control training (RESIST)

WW + daily gamified inhibitory control training

Group Type EXPERIMENTAL

Inhibitory control training (RESIST)

Intervention Type BEHAVIORAL

Participants assigned to RESIST (Arms 3 \& 4) will receive 6 months of coaching (Zoom and/or email/text) and gamified inhibitory control training.

WW

Intervention Type BEHAVIORAL

Participants assigned to all arms will receive 6 months of coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills.

WW + Home food modification and grocery delivery (AVOID) + Inhibitory control training (RESIST)

WW + modification of home food environment + online grocery shopping and delivery + daily gamified inhibitory control training

Group Type EXPERIMENTAL

Home food environment and grocery delivery (AVOID)

Intervention Type BEHAVIORAL

Participants (Arms 2 \& 4) will receive 6 months of coaching (Zoom and/or email/text) to modify their home food environment and alter cues to promote healthy food choices

Inhibitory control training (RESIST)

Intervention Type BEHAVIORAL

Participants assigned to RESIST (Arms 3 \& 4) will receive 6 months of coaching (Zoom and/or email/text) and gamified inhibitory control training.

WW

Intervention Type BEHAVIORAL

Participants assigned to all arms will receive 6 months of coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills.

Interventions

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Home food environment and grocery delivery (AVOID)

Participants (Arms 2 \& 4) will receive 6 months of coaching (Zoom and/or email/text) to modify their home food environment and alter cues to promote healthy food choices

Intervention Type BEHAVIORAL

Inhibitory control training (RESIST)

Participants assigned to RESIST (Arms 3 \& 4) will receive 6 months of coaching (Zoom and/or email/text) and gamified inhibitory control training.

Intervention Type BEHAVIORAL

WW

Participants assigned to all arms will receive 6 months of coaching (Zoom and/or email/text) and commercially-available weight management program focusing on diet, physical activity and mindset skills.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older
* BMI between 25-45 kg/m2
* Read, write, and speak English with acceptable visual acuity
* Has a household member (≥ 14 years) willing to complete three brief assessments over 12 months\* \*Only applies to individuals who indicate they are cohabitating with at least one eligible household member


* 14-years-old
* Parent consent for children \<18-years-old
* Willingness to complete assessments / measurements

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 with severe cognitive delays or visual/hearing impairment
* Individuals who are unable or unwilling to complete the study assessments / measurements


* ≤ 14-years-old
* Individuals who are unable or unwilling to complete the study assessments / measurements
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Riverside

OTHER

Sponsor Role collaborator

WW International Inc

INDUSTRY

Sponsor Role collaborator

The University of Tennessee, Knoxville

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Northeastern University

OTHER

Sponsor Role collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sarah Salvy

Professor, Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah-Jeanne Salvy, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Sobolev M, Ruiz J, Diniz MA, Raynor H, Foster GD, Seitz AR, Salvy SJ. Preference for behavior change strategies in randomized controlled trials: Evidence from weight management. Contemp Clin Trials. 2025 Sep;156:108031. doi: 10.1016/j.cct.2025.108031. Epub 2025 Jul 28.

Reference Type DERIVED
PMID: 40738220 (View on PubMed)

Caceres NA, Yu Q, Capaldi J, Diniz MA, Raynor H, Foster GD, Seitz AR, Salvy SJ. Evaluating environmental and inhibitory control strategies to improve outcomes in a widely available weight loss program. Contemp Clin Trials. 2022 Aug;119:106844. doi: 10.1016/j.cct.2022.106844. Epub 2022 Jul 5.

Reference Type DERIVED
PMID: 35798248 (View on PubMed)

Other Identifiers

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1R01DK130851-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001652

Identifier Type: -

Identifier Source: org_study_id