Avoid and Resist Strategies for Weight Management

Overseen By Jessica Capaldi, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Bariatric surgery, Pregnancy, Unstable coronary artery disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two strategies to help individuals with overweight or obesity manage their weight and improve their diet. One approach, AVOID, focuses on changing the home food environment and using grocery delivery. The other, RESIST, trains impulse control through inhibitory control training. Participants will receive the WW program, which supports diet, exercise, and mindset, along with either or both strategies. Ideal participants have a BMI of 25-45, are not enrolled in other weight loss programs, and have a household member willing to participate in brief assessments. As an unphased trial, this study offers a unique opportunity to contribute to innovative weight management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have conditions like unstable coronary artery disease or uncontrolled insulin-dependent diabetes, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that changing the home food environment and using grocery delivery can improve diet. An eight-week study found these methods helped people develop healthier eating habits at home. The study reported no major safety issues, so this approach is considered safe.

Inhibitory control training, which includes exercises to boost self-control with food, has been studied for its effects on weight management. Results suggest it can improve weight and mental well-being. This training poses no major safety concerns, as it mainly involves mental exercises.

Both methods appear promising with minimal side effects, making them safe options for those looking to manage their weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these weight management strategies because they go beyond traditional diet and exercise plans. The "Avoid" strategy enhances the home environment by promoting healthier food choices through online grocery delivery, making it easier for individuals to avoid unhealthy temptations. The "Resist" strategy incorporates daily gamified inhibitory control training, which is a novel approach to strengthen self-control and resist impulses to overeat. By combining these innovative strategies with the established WW program, researchers hope to discover more effective ways to support long-term weight management.

What evidence suggests that this trial's treatments could be effective for weight management?

Research has shown that changing the types of food kept at home and using grocery delivery services can aid in weight loss. An 8-week study found that people who had groceries delivered made healthier food choices at home, supporting better weight management. In this trial, one group will receive WW combined with home food modification and grocery delivery (AVOID).

Other studies have found that adding fun brain training exercises to improve self-control to a weight loss program like WW is feasible and doesn't reduce participation. In this trial, another group will receive WW combined with inhibitory control training (RESIST).

These findings suggest that combining these methods—altering home food choices and enhancing self-control—might effectively aid in weight loss and healthier eating. Participants in this trial may also receive a combination of both strategies alongside WW. ^{6 7 8 9 10}

Who Is on the Research Team?

Sarah-Jeanne Salvy, PhD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adults and children over 14 with obesity, having a BMI between 25-40. Participants must be able to read, write, and speak English with good vision. Children under 18 need parent consent. It's aimed at those willing to complete various assessments.

Inclusion Criteria

My parents have agreed to my participation in the trial.

You are willing to participate in required assessments and measurements.

I am 14 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are enrolled in a 12-month weight-management program and randomized to one of four study arms: WW only, WW + AVOID, WW + RESIST, or WW + AVOID + RESIST.

12 months

Baseline, 6-month, and 12-month assessments

Follow-up

Participants are monitored for changes in health, diet, and exercise, and complete participant experience interviews.

6 months

6-month and 12-month assessments

What Are the Treatments Tested in This Trial?

Interventions

• Home food environment and grocery delivery
• Inhibitory control training
• WW

Trial Overview

The study is testing two weight management strategies: AVOID involves changing the home food environment and grocery delivery; RESIST focuses on training to control impulses. The effectiveness of these against WW (formerly Weight Watchers) will be compared.

How Is the Trial Designed?

Group I: WW + Inhibitory control training (RESIST) Experimental Treatment 2 Interventions

WW + daily gamified inhibitory control training

Group II: WW + Home modification and grocery delivery (AVOID) Experimental Treatment 2 Interventions

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

Group III: WW + Home food modification and grocery delivery (AVOID) + Inhibitory control training (RESIST) Experimental Treatment 3 Interventions

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

Group IV: WW Only Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

WW International Inc

Industry Sponsor

Trials

25

Recruited

5,300+

Weight Watchers International

Industry Sponsor

Trials

23

Recruited

5,100+

The University of Tennessee, Knoxville

Collaborator

Trials

93

Recruited

19,500+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of California, Riverside

Collaborator

Trials

33

Recruited

14,400+

Published Research Related to This Trial

The revised My Body Knows When (MBKW) program showed significant improvements in intuitive eating behaviors among 56 overweight or obese military adults over a 10-week period, including reductions in emotional eating and reliance on external eating cues.

Participants experienced a modest weight loss (average decrease of 0.4 kg/m² in BMI), indicating that the program may help promote healthier eating habits, although further research with a larger sample size is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The My Body Knows When Program Increased Intuitive Eating Characteristics in a Military Population. Cole, RE., Meyer, SA., Newman, TJ., et al.[2020]

Food-specific inhibitory control training is feasible and effective in reducing cravings for high-energy dense foods and improving mood in individuals with disinhibited eating, as shown in a study of 94 adults over a 2-week intervention period.

Participants who underwent the training reported significant reductions in binge eating symptoms, perceived hunger, and depression, indicating that this approach may help manage disordered eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based feasibility randomized controlled study to test food-specific inhibitory control training in people with disinhibited eating during COVID-19 in Italy. Cardi, V., Meregalli, V., Di Rosa, E., et al.[2022]

In a study involving 1234 participants using the FoodT app, those who completed more Go/No-Go training trials showed small but significant reductions in unhealthy food intake and increases in healthy food intake over one month.

The results suggest that engaging with app-based food Go/No-Go training can positively influence dietary habits, although further experimental research is needed to confirm these findings and address potential biases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-based food Go/No-Go training: User engagement and dietary intake in an opportunistic observational study. Aulbach, MB., Knittle, K., van Beurden, SB., et al.[2022]

In a study of 83 predominantly overweight or obese adults, online response inhibition training targeting high-energy density foods led to significant weight loss and reduced daily energy intake compared to a control group.

Participants who underwent the active training not only lost weight but also reported a decreased liking for high-energy foods, indicating that this intervention could be an effective strategy for reducing food consumption and improving public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training response inhibition to food is associated with weight loss and reduced energy intake. Lawrence, NS., O'Sullivan, J., Parslow, D., et al.[2022]

A pilot study involving 60 overweight or obese participants showed that approach-avoidance training (AAT) delivered via smartphone apps effectively reduced the tendency to approach unhealthy foods and increased the choice of healthy foods.

In contrast, episodic future thinking (EFT) did not significantly impact delay discounting or food choices, suggesting that AAT is a more effective cognitive training strategy for improving food choices in obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based cognitive bias modification training improves healthy food choice in obesity: A pilot study. Kakoschke, N., Hawker, C., Castine, B., et al.[2019]

In a 6-month weight loss program involving 90 overweight adults, participants reported a significant reduction in the visibility of high-fat foods in their homes, indicating a positive change in their home food environment.

Despite these changes, the study found no direct link between modifications in the home food environment and actual weight loss, highlighting the complexity of factors influencing obesity treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in home food availability of high- and low-fat foods after a behavioral weight control program are regional not racial. Krukowski, RA., Harvey-Berino, J., West, DS.[2023]

Episodic future thinking (EFT) significantly reduced the number of calories purchased per family member among mothers who were overweight or obese, indicating its potential as an effective intervention for healthier grocery shopping habits.

In two studies involving 57 mothers, those using goal-directed EFT purchased fewer calories compared to control groups, suggesting that EFT can help improve the home food environment and promote better family eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Episodic future thinking and grocery shopping online. Hollis-Hansen, K., Seidman, J., O'Donnell, S., et al.[2023]

A pilot study with 28 overweight participants showed that using a grocery home delivery service alongside standard behavioral weight loss treatment significantly reduced the number of foods in the home, particularly high-fat items.

While both treatment groups lost similar amounts of weight over 8 weeks, there was a trend suggesting that more frequent home deliveries correlated with weight loss, indicating potential benefits of this approach for healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home grocery delivery improves the household food environments of behavioral weight loss participants: results of an 8-week pilot study. Gorin, AA., Raynor, HA., Niemeier, HM., et al.[2021]

In a study involving 94 obese women over 16 weeks, a cognitive self-instructional procedure aimed at improving self-control in eating did not lead to significant differences in weight reduction compared to other treatment methods.

Despite no differences in weight loss, participants experienced significant reductions in anxiety and depression, suggesting that the program had positive psychological effects even if it didn't change weight outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of self-instructional training in the treatment of obesity. Bennett, GA.[2019]

A study involving 35 participants with loss-of-control eating (LOC) found that both virtual reality (VR) and standard computer-based inhibitory control trainings (ICTs) were feasible and well-accepted, with high retention and compliance over six weeks.

While daily training led to significant reductions in LOC episodes, there were no meaningful differences in effectiveness between the ICT types or modalities, suggesting that further research is needed to enhance the efficacy of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does virtual reality enhance the effects of inhibitory control training for loss-of-control eating? A pilot factorial experiment. Manasse, SM., Trainor, C., Payne-Reichert, A., et al.[2023]

Cognitive training interventions, such as inhibition training and episodic future thinking, have been shown to significantly improve eating behaviors and may aid in weight loss, based on a meta-analysis of 66 studies.

While these cognitive strategies show promise, most studies focused on short-term outcomes in normal-weight individuals, highlighting the need for longer-term research in clinical populations, particularly those with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training on eating behaviour and weight loss: A meta-analysis and systematic review. Yang, Y., Shields, GS., Wu, Q., et al.[2020]

Computerized response-inhibition training can help individuals who overeat by reducing their consumption of specific foods, as shown in an experiment where participants ate less of a food after training to inhibit responses to food pictures.

The effectiveness of this training appears to be influenced by individual dietary restraint, with restrained eaters showing a greater reduction in food intake after stop-training compared to other training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stopping to food can reduce intake. Effects of stimulus-specificity and individual differences in dietary restraint. Lawrence, NS., Verbruggen, F., Morrison, S., et al.[2022]

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