Clinical trial NCT05143931: Avoid and Resist Strategies for Weight Management
Official title: Evaluating Environmental Control (AVOID) and Inhibitory Control (RESIST) Strategies to Improve Weight Management Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Overweight
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, Riverside
name: WW International Inc
name: The University of Tennessee, Knoxville
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Northeastern University
First posted: 2021-12-03
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-site, prospective, four-parallel-arm, randomized controlled trial
Primary purpose: TREATMENT

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).

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 25-45 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.

Eligibility 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

Primary outcomes:
measure: Change in BMI from baseline to 12 months.
timeFrame: Baseline, 6-month, 12-month
Secondary outcomes:
measure: Diet quality assessed by 24h-dietary recall
timeFrame: Baseline, 6-month, 12-month
Other outcomes:
measure: Home availability of healthy and unhealthy foods and beverages
timeFrame: Baseline, 6-month, 12-month
measure: Flanker task
timeFrame: Baseline, 6-month, 12-month
measure: Continuous Performance Task Go/No-Go
timeFrame: Baseline, 6-month, 12-month
measure: Set-Shifting
timeFrame: Baseline, 6-month, 12-month
measure: Demographics
timeFrame: Baseline only
measure: Executive Functioning
timeFrame: Baseline, 6-month, 12-month
measure: WW Process Data
timeFrame: monthly between baseline and 12-month
measure: Grocery Delivery Process data
timeFrame: monthly between baseline and 12-month
measure: PolyRules! Process data
timeFrame: monthly between baseline and 12-month
measure: Physical activity
timeFrame: Baseline, 6-month, 12-month
measure: Eating attitudes
timeFrame: Baseline, 6-month, 12-month
measure: Food Security Questionnaire
timeFrame: Baseline only
measure: Changes in Health and Lifestyle.
timeFrame: 6-month, 12-month
measure: Participant Experience Interview
timeFrame: withdrawal or 6-month and 12-month
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Sarah-Jeanne Salvy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.