Avoid and Resist Strategies for Weight Management

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Overweight

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-site, prospective, four-parallel-arm, randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WW Only<br>WW is commercially-available weight management program focusing on diet, physical activity and mindset skills. | Behavioral: WW<br>* 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.<br>|
| Experimental: WW + Home modification and grocery delivery (AVOID)<br>WW + modification of home food environment + online grocery shopping and delivery | Behavioral: Home food environment and grocery delivery (AVOID)<br>* 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<br>Behavioral: WW<br>* 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.<br>|
| Experimental: WW + Inhibitory control training (RESIST)<br>WW + daily gamified inhibitory control training | Behavioral: Inhibitory control training (RESIST)<br>* Participants assigned to RESIST (Arms 3 & 4) will receive 6 months of coaching (Zoom and/or email/text) and gamified inhibitory control training.<br>Behavioral: WW<br>* 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.<br>|
| Experimental: WW + Home food modification and grocery delivery (AVOID) + Inhibitory control training (RESIST)<br>WW + modification of home food environment + online grocery shopping and delivery + daily gamified inhibitory control training | Behavioral: Home food environment and grocery delivery (AVOID)<br>* 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<br>Behavioral: Inhibitory control training (RESIST)<br>* Participants assigned to RESIST (Arms 3 & 4) will receive 6 months of coaching (Zoom and/or email/text) and gamified inhibitory control training.<br>Behavioral: WW<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |