Dietary Strategies for Obesity

Overseen By Michele L Patel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Weight loss drugs, Antipsychotics

Disqualifiers: Pregnancy, Bariatric surgery, Cancer, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best mix of diet strategies for weight loss using a digital program. The focus includes reducing high-calorie, low-nutrition foods, managing eating times, and increasing protein and fiber intake. Participants will track their weight daily and engage in weekly lessons from home over 12 weeks. The program centers on a Behavioral Weight Loss Intervention, incorporating strategies such as increasing fiber and protein intake, limiting the eating window, and avoiding certain "red zone" foods. The trial seeks U.S. adults with a body mass index (BMI) between 25.0 and 45.0 who wish to lose weight through lifestyle changes. As an unphased trial, this study offers a unique opportunity to explore innovative weight loss strategies from home.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using weight loss or anti-obesity medications, or if your medication might impact weight loss.

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

Research has shown that programs focused on changing behavior can safely and effectively help manage obesity. The U.S. Preventive Services Task Force recommends these programs for adults with a BMI of 30 or higher, noting their benefits without major safety concerns.

Eating more fiber is generally safe and linked to weight loss and lower health risks. Studies indicate that higher fiber intake can lead to a healthier weight and reduce risks related to obesity.

Diets with more protein can aid in weight loss and are usually safe for healthy individuals. However, the long-term effects of high protein consumption require further research.

Time-restricted eating, such as eating only during an 8-hour period each day, can help reduce calorie intake. While generally safe, some studies suggest it might affect heart health, so personal health considerations are important.

Avoiding "Red Zone Foods," which are high in calories but low in nutrition, is a common weight management strategy. This approach is generally safe as it focuses on improving diet quality without eliminating necessary nutrients.

Overall, these strategies are considered safe for healthy adults, but individual health conditions should be taken into account. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these dietary strategies for obesity because they offer a personalized approach, combining core behavioral interventions with specific dietary adjustments. Unlike standard options that often rely on medication or generic diet plans, these strategies tailor the diet by increasing protein and fiber intake, limiting high-risk foods, and controlling eating windows. This multifaceted approach targets obesity by addressing not just calorie intake, but also nutrient quality and timing, potentially leading to more sustainable weight loss. By customizing these elements, the treatment could offer more effective and long-lasting results than traditional methods.

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

Research has shown that programs like the Core Behavioral Weight Loss Intervention, which participants in this trial will receive, can help people lose weight. Studies have found that participants often lose between 2% and 5% of their starting weight with these methods. In this trial, some participants will focus on increasing fiber intake, which is linked to weight loss by lowering body mass index (BMI) and promoting fullness. Others will increase protein intake, as high-protein diets can help people lose weight and reduce body fat. Another group will practice time-restricted eating, consuming food only during certain hours, which can help reduce calorie intake and support weight loss. Additionally, some participants will focus on cutting back on Red Zone Foods, which are high in calories but low in nutrition, to promote healthier eating and possible weight loss. Research supports that each of these strategies can work well alone or together, and this trial will explore their effectiveness in various combinations. ^{2 3 6 7 8}

Who Is on the Research Team?

Michele L Patel, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

The Reset trial is for adults living in the U.S. with overweight or obesity issues. Participants will engage in a digital weight loss program focusing on healthy eating and physical activity, requiring daily body weight tracking and weekly lessons.

Inclusion Criteria

I am 18 years old or older.

Body mass index (BMI) 25.0 to 45.0 kg/m^2

Cellphone ownership with a texting plan

Exclusion Criteria

Living with someone else participating in the study

I have a condition or take medication that makes weight loss unsafe.

Investigator discretion for safety reasons

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Assessment of body weight and survey measures at the beginning of the trial

1 week

Remote assessment

Treatment

Participants engage in a 12-week digital weight loss intervention with dietary strategies and self-monitoring

12 weeks

Remote activities

Follow-up

Participants are monitored for weight change and physical activity at 1 month and 3 months

3 months

Remote assessment at 1 month and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Core Behavioral Weight Loss Intervention
• Increase Fiber Intake
• Increase Protein
• Limit Eating Window
• Limit Red Zone Foods

Trial Overview This study tests four dietary strategies: limiting high-calorie low-nutrition foods, reducing eating times, increasing protein intake, and boosting fiber consumption. The goal is to determine which combination best promotes weight loss over a 12-week period.

How Is the Trial Designed?

Group I: Condition 9 Experimental Treatment 2 Interventions

Core + Limit Red Zone Foods

Group II: Condition 8 Experimental Treatment 4 Interventions

Core + Limit Eating Window + Increase Protein + Increase Fiber

Group III: Condition 7 Experimental Treatment 3 Interventions

Core + Limit Eating Window + Increase Protein

Group IV: Condition 6 Experimental Treatment 3 Interventions

Core + Limit Eating Window + Increase Fiber

Group V: Condition 5 Experimental Treatment 2 Interventions

Core + Limit Eating Window

Group VI: Condition 4 Experimental Treatment 3 Interventions

Core + Increase Protein + Increase Fiber

Group VII: Condition 3 Experimental Treatment 2 Interventions

Core + Increase Protein

Group VIII: Condition 2 Experimental Treatment 2 Interventions

Core + Increase Fiber

Group IX: Condition 16 Experimental Treatment 5 Interventions

Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein + Increase Fiber

Group X: Condition 15 Experimental Treatment 4 Interventions

Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein

Group XI: Condition 14 Experimental Treatment 4 Interventions

Core + Limit Red Zone Foods + Limit Eating Window + Increase Fiber

Group XII: Condition 13 Experimental Treatment 3 Interventions

Core + Limit Red Zone Foods + Limit Eating Window

Group XIII: Condition 12 Experimental Treatment 4 Interventions

Core + Limit Red Zone Foods + Increase Protein + Increase Fiber

Group XIV: Condition 11 Experimental Treatment 3 Interventions

Core + Limit Red Zone Foods + Increase Protein

Group XV: Condition 10 Experimental Treatment 3 Interventions

Core + Limit Red Zone Foods + Increase Fiber

Group XVI: Condition 1 Experimental Treatment 1 Intervention

Core Only

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Stanford Nutrition and Obesity Research Center

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7042080/

The WORD: Outcomes results of a behavioral weight loss ... The WORD produced weight loss from baseline to 6 months (−2.47 (−3.13, −1.80)). Among those who lost 5% of their baseline weight, there was a ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2702878

Behavioral Weight Loss Interventions to Prevent Obesity ... Participants in weight loss maintenance interventions had less weight gain compared with participants in control groups (pooled mean difference ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.123.009965

Long-Term Outcomes Following Behavioral Weight ... Existing weight loss strategies are aimed to reduce the long-term adverse effects of obesity. These include behavioral weight management ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1108660

Weight-Loss Interventions in Clinical Practice The percentage of participants who lost 5% or more of their initial weight was 18.8% in the control group, 38.2% in the group receiving remote support only, and ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/obr.13839

The impact of behavioral weight management interventions ... The present study describes a systematic review and meta-analysis of the impact of BWMIs on eating behavior traits in children with overweight or obesity.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532375/

Results - Behavioral and Pharmacotherapy Weight Loss ... Overall, approximately two-thirds of the trials (k=19) included adults who were overweight or had obesity, with 11 trials limited to adults with obesity (BMI ≥ ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/15374416.2023.2251164

Evidence Base Update on Behavioral Treatments for ... This review provides an update to a previous Evidence Base Update addressing behavioral treatments for overweight and obesity in children and adolescents.

8. aafp.org aafp.org/pubs/afp/issues/2019/0415/od1.html

Behavioral Weight Loss Interventions to Prevent Obesity ... The USPSTF found adequate evidence that behavior-based weight loss interventions in adults with obesity can lead to clinically significant improvements in ...