Avoid and Resist Strategies for Weight Management

Obesity Clinical Trial

Official title:

Evaluating Environmental Control (AVOID) and Inhibitory Control (RESIST) Strategies to Improve Weight Management Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05143931
• Other study ID #: STUDY00001652
• Secondary ID: 1R01DK130851-01
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: February 9, 2027

Study information

• Verified date: June 2024
• Source: Cedars-Sinai Medical Center
• Contact: Nenette Caceres, PhD
• Phone: 3104232062
• Email: nenette.caceres[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 9, 2027
• Est. primary completion date: June 6, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• 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
• 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.
• 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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (6)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northeastern University, The University of Tennessee, Knoxville, University of California, Riverside, WW International Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Home availability of healthy and unhealthy foods and beverages	Participants will self-report the availability of fruits and vegetables, servings of whole grains, red/processed meat, alcoholic beverages and food/beverages with added sugars in participants' homes. Responses will be scored as availability of healthy foods and beverages (e.g., fruits and vegetables), and availability of less healthy foods and beverages (e.g., processed meat, food/beverages with added sugars).	Baseline, 6-month, 12-month
Other	Flanker task	Participants have 1000ms to identify which direction a central arrow is pointing. Participants complete 64 congruent and incongruent randomly mixed trials. In congruent trials flanking stimuli points in the same direction as the central stimulus while in incongruent trials flanking stimuli points in the opposite direction.	Baseline, 6-month, 12-month
Other	Continuous Performance Task Go/No-Go	Participants respond to a target shape (e.g. a white five-pointed star) and withhold a response from non-target shapes. In 20% of presented trials an inhibitory response will be required.	Baseline, 6-month, 12-month
Other	Set-Shifting	Participants categorize colored shapes by color or shape in three blocks. In the first two blocks, participants categorize shapes for 20 trials. In the third block, the categorization rules are randomly interleaved, and participants switch between rules. Participants have 1500ms to identify the stimulus and complete 96 trials with a 25% chance of rule-switching.	Baseline, 6-month, 12-month
Other	Demographics	Participants will complete a questionnaire surveying: date of birth, sex, socioeconomic status (education level, household income, marital status, employment status), household composition (multigenerational, single, married, cohabitating, children) and race/ethnicity.	Baseline only
Other	Executive Functioning	The Behavior Rating Inventory of Executive Function®- Adult Version (BRIEF-A) is a standardized measure of executive functions or self-regulation in everyday environment. The BRIEF-A assesses nine non-overlapping theoretically and empirically derived clinical scales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. BRIEF-A is available in English and Spanish and can be computer-administered. Baseline score on the BRIEF will be tested as moderator of the relationships between study arms and outcomes.	Baseline, 6-month, 12-month
Other	WW Process Data	Interactions such as tracked food, weight and activity in WW app will be passively recorded to operationalize engagement. A higher score indicates greater engagement.	monthly between baseline and 12-month
Other	Grocery Delivery Process data	Frequency of grocery delivery and dining out/take out will be recorded through participants' self-report of grocery delivery. Higher frequencies of grocery delivery indicates greater engagement.	monthly between baseline and 12-month
Other	PolyRules! Process data	Frequency/duration of gamified cognitive training will be passively recorded by the PolyRules! app. Greater frequency and duration indicate greater engagement.	monthly between baseline and 12-month
Other	Physical activity	The International Physical Activity Questionnaire (IPAQ) will be used to assess activity in 5 domains: job-related; transportation; housework, house maintenance, and caring for family; recreation, sport, and leisure-time physical activity; and time spent sitting. Data conferred by the WW program will also be leveraged, as participants track their activity (type, duration and intensity) via the WW mobile app or online website. Investigators will examine how engagement in exercise and daily activities moderate the relationships between study arms and outcomes.	Baseline, 6-month, 12-month
Other	Eating attitudes	The Dutch Eating Behavior Questionnaire (DEBQ) will be used to assess participants' approach to food and eating along three dimensions: emotional, external and restricted eating. There is a high degree of stability for each of these three eating behavior scales. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.	Baseline, 6-month, 12-month
Other	Food Security Questionnaire	The Food Security Questionnaire will be used to evaluate the availability of nutritious and safe foods for participants and their households at all times. The questionnaire will assess the household's ability to meet their food needs and will determine their placement on a food security continuum based on their responses to a series of questions. Researchers will analyze how food security impacts the relationships between different study arms and the outcomes.	Baseline only
Primary	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	Diet quality assessed by 24h-dietary recall	Gold standard interviewer-administered, multi-pass 24h-recalls (2 weekdays, 1 weekend day) will be used to measure diet quality. The Nutrition Data System for Research software (Nutrition Coordinating Center, University of Minnesota) is used to analyze the data. Investigators will use the 24h-recalls to assess changes in participants and household members' overall diet quality, based on adherence to the dietary guidelines for fruits and vegetables, servings of whole grains, red/processed meat, alcoholic beverages and food/beverages with added sugars.	Baseline, 6-month, 12-month