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NCT05143931 | Recruiting | Obesity


Avoid and Resist Strategies for Weight Management
Sponsor:

Cedars-Sinai Medical Center

Information provided by (Responsible Party):

Sarah Salvy

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).

Condition or disease

Obesity

Overweight

Intervention/treatment

Home food environment and grocery delivery (AVOID)

Inhibitory control training (RESIST)

WW

Phase

Not Applicable

Detailed Description:

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 25-40 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.

Study Type : Interventional
Estimated Enrollment : 500 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluating Environmental Control (AVOID) and Inhibitory Control (RESIST) Strategies to Improve Weight Management Outcomes
Actual Study Start Date : June 6, 2022
Estimated Primary Completion Date : December 1, 2026
Estimated Study Completion Date : February 9, 2027
Arm Intervention/treatment

Active Comparator: WW Only

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

Behavioral: WW

Behavioral: Home food environment and grocery delivery (AVOID)

Experimental: WW + Home modification and grocery delivery (AVOID)

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

Behavioral: WW

Behavioral: Inhibitory control training (RESIST)

Experimental: WW + Inhibitory control training (RESIST)

WW + daily gamified inhibitory control training

Behavioral: WW

Behavioral: Home food environment and grocery delivery (AVOID)

Experimental: 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

Behavioral: Inhibitory control training (RESIST)

Behavioral: WW

Ages Eligible for Study: 14 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria (Main participants)
  • Age 18 years or older
  • BMI between 25-40 kg/m2
  • Read, write, and speak English with acceptable visual acuity
  • Inclusion Criteria (Household participants)
    • 14-years-old
    • Parent consent for children <18-years-old
    • Willingness to complete assessments / measurements
    Exclusion Criteria (Main participants)
    • 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
    Exclusion Criteria (Household participants)
    • ≤ 14-years-old
    • Individuals who are unable or unwilling to complete the study assessments / measurements

Avoid and Resist Strategies for Weight Management

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Avoid and Resist Strategies for Weight Management

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Locations


Recruiting

United States, California

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90069

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