NCT05143931

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
503

participants targeted

Target at P75+ for not_applicable obesity

Timeline
9mo left

Started Jun 2022

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jun 2022Feb 2027

First Submitted

Initial submission to the registry

November 10, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

November 10, 2021

Last Update Submit

February 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in BMI from baseline to 12 months.

    BMI will be calculated by aggregating participants' self-reported height in meters and weight in kilograms at baseline, 6- and 12-months.

    Baseline, 6-month, 12-month

Secondary Outcomes (1)

  • Diet quality assessed by 24h-dietary recall

    Baseline, 6-month, 12-month

Other Outcomes (14)

  • Home availability of healthy and unhealthy foods and beverages

    Baseline, 6-month, 12-month

  • Flanker task

    Baseline, 6-month, 12-month

  • Continuous Performance Task Go/No-Go

    Baseline, 6-month, 12-month

  • +11 more other outcomes

Study Arms (4)

WW Only

ACTIVE COMPARATOR

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

Behavioral: WW

WW + Home modification and grocery delivery (AVOID)

EXPERIMENTAL

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

Behavioral: Home food environment and grocery delivery (AVOID)Behavioral: WW

WW + Inhibitory control training (RESIST)

EXPERIMENTAL

WW + daily gamified inhibitory control training

Behavioral: Inhibitory control training (RESIST)Behavioral: WW

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

EXPERIMENTAL

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

Behavioral: Home food environment and grocery delivery (AVOID)Behavioral: Inhibitory control training (RESIST)Behavioral: WW

Interventions

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

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

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

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

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90069, United States

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah-Jeanne Salvy, PhD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Capaldi, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: single-site, prospective, four-parallel-arm, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Medicine

Study Record Dates

First Submitted

November 10, 2021

First Posted

December 3, 2021

Study Start

June 6, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 9, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations