Avoid and Resist Strategies for Weight Management

Recruiting in Palo Alto (17 mi)

Overseen by Sarah-Jeanne Salvy, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Cedars-Sinai Medical Center

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests two methods to help people with overweight or obesity lose weight and eat healthier. One method changes the home food environment to make healthier choices easier (AVOID), and the other improves self-control over food choices through training (RESIST).

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.

What data supports the effectiveness of the treatment involving home food environment and grocery delivery, online grocery shopping and delivery, and cognitive control training for weight management?

Research suggests that cognitive training, including inhibitory control training, can positively influence eating behavior and potentially aid in weight loss. However, more long-term studies are needed to confirm these effects in people with obesity. ^{1 2 3 4 5}

Is the Avoid and Resist Strategies for Weight Management treatment safe for humans?

The studies suggest that the strategies, including home grocery delivery and response inhibition training, are generally safe and well-tolerated by participants, with no significant safety concerns reported. ^{6 7 8 9 10}

How does the Avoid and Resist Strategies for Weight Management treatment differ from other weight management treatments?

This treatment is unique because it focuses on cognitive strategies like episodic future thinking (EFT) and response inhibition training to help individuals make healthier food choices and reduce calorie intake, rather than relying on traditional methods like diet or exercise alone. These cognitive approaches aim to change how people think about food and their future, which can lead to more sustainable weight management. ^{5 7 10 11 12}

Research Team

Sarah-Jeanne Salvy, PhD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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.

You must be able to read, write, and speak English well enough to participate in the study.

Trial Timeline

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

Treatment Details

Interventions

• Home food environment and grocery delivery (Behavioral Intervention)
• Inhibitory control training (Behavioral Intervention)
• WW (Behavioral Intervention)

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.

Participant Groups

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+

David E. Cohen

Cedars-Sinai Medical Center

Chief Medical Officer

MD and PhD in Physiology and Biophysics from Harvard University

Peter L. Slavin

Cedars-Sinai Medical Center

Chief Executive Officer

MD from Harvard Medical School, MBA from Harvard Business School

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

Jared Auclair

Northeastern University

Chief Executive Officer

PhD in Biomedical Science from the University of Massachusetts Medical School

Anantdeep Kaur

Northeastern University

Chief Medical Officer since 2023

Master’s and Doctorate in Biotechnology from the University of Technology Sydney

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+

Randy Boyd

The University of Tennessee, Knoxville

Chief Executive Officer since 2019

Bachelor's degree from the University of Tennessee, Knoxville

Dr. Ogram

The University of Tennessee, Knoxville

Chief Medical Officer since 2018

PhD in Microbiology with a concentration in Molecular Virology from the University of Tennessee, Knoxville

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

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

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

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

Chief Medical Officer since 2007

MD, M.A.C.P.

University of California, Riverside

Collaborator

Trials

33

Recruited

14,400+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The My Body Knows When Program Increased Intuitive Eating Characteristics in a Military Population. [2020]

2. Germany 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Does virtual reality enhance the effects of inhibitory control training for loss-of-control eating? A pilot factorial experiment. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Cognitive training on eating behaviour and weight loss: A meta-analysis and systematic review. [2020]

6. England 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Episodic future thinking and grocery shopping online. [2023]

8. England 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Stopping to food can reduce intake. Effects of stimulus-specificity and individual differences in dietary restraint. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Training response inhibition to food is associated with weight loss and reduced energy intake. [2022]

11. England pubmed.ncbi.nlm.nih.gov

App-based food Go/No-Go training: User engagement and dietary intake in an opportunistic observational study. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Smartphone-based cognitive bias modification training improves healthy food choice in obesity: A pilot study. [2019]