Avoid and Resist Strategies for Weight Management

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Overweight; Obesity

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

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05143931

STUDY00001652

1R01DK130851-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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 25-45 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Main participants):

• 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 4 patient groups

WW Only

Active Comparator group

Description:

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

Treatment:

Behavioral: WW

WW + Home modification and grocery delivery (AVOID)

Experimental group

Description:

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

Treatment:

Behavioral: WW

Behavioral: Home food environment and grocery delivery (AVOID)

WW + Inhibitory control training (RESIST)

Experimental group

Description:

WW + daily gamified inhibitory control training

Treatment:

Behavioral: WW

Behavioral: Inhibitory control training (RESIST)

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

Experimental group

Description:

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

Treatment:

Behavioral: WW

Behavioral: Home food environment and grocery delivery (AVOID)

Behavioral: Inhibitory control training (RESIST)