What is the mechanism of action of this treatment?

The most common treatments for obesity, particularly those involving self-monitoring and behavioral modification, work by helping patients become more aware of their eating and activity patterns. Self-monitoring involves tracking food intake, physical activity, and body weight, which can increase accountability and highlight areas for improvement. Behavioral modification includes setting realistic goals, developing action plans, and learning coping strategies to manage high-risk situations for overeating. These mechanisms are crucial for obesity patients as they promote sustainable lifestyle changes, improve adherence to dietary and exercise regimens, and ultimately lead to effective weight loss and better overall health.

What side effects are associated with this type of intervention?

Common treatments for obesity, such as self-monitoring, dietary changes, and behavioral modification, are generally safe but can have some side effects. These may include initial fatigue or muscle soreness from increased physical activity, and gastrointestinal discomfort or nutrient deficiencies from dietary changes. Behavioral modifications can sometimes lead to psychological stress or frustration, especially if weight loss goals are not met. Additionally, for individuals on psychotropic medications, side effects like sedation, anticholinergic effects, and weight gain can interfere with the effectiveness of lifestyle interventions.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including lorcaserin, phentermine-topiramate, and liraglutide. These medications often complement lifestyle interventions such as self-monitoring and behavioral modification, which are key components of the Digital Weight Loss Intervention trial. Lorcaserin, for instance, works by promoting a feeling of fullness, while phentermine-topiramate combines an appetite suppressant with a medication that increases satiety. Liraglutide, originally used for diabetes, also aids in weight loss by slowing gastric emptying and reducing appetite. These pharmacological treatments, when combined with behavioral strategies, can enhance weight loss outcomes.

What other types of research exist?

Promising, novel alternatives to digital weight loss interventions for obesity patients in 2024 include: 1) Pharmacological treatments such as GLP-1 receptor agonists (e.g., semaglutide) which have shown significant efficacy in weight loss. 2) Bariatric surgery options like sleeve gastrectomy and gastric bypass, which are effective for severe obesity. 3) Endoscopic procedures such as intragastric balloons and endoscopic sleeve gastroplasty, which are less invasive than traditional surgery. 4) Personalized medicine approaches that tailor treatment plans based on genetic, metabolic, and behavioral profiles. 5) Integration of artificial intelligence and machine learning to provide personalized dietary and exercise recommendations. 6) Use of virtual reality (VR) and augmented reality (AR) for immersive behavioral therapy and physical activity engagement.

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Digital Weight Loss Goal Setting for Obesity

N/A

Waitlist Available

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find the best goal levels in a digital weight loss program for adults with overweight or obesity. Participants will use digital tools to monitor their weight, food intake, and activity while receiving personalized advice. The study will test different goal intensities to see which ones work best.

Who is the study for?

This trial is for adults living in the US with a BMI of 25.0 to 45.0 who want to lose weight using behavioral strategies and are willing to use digital tools like Fitbit. It's not for those on other weight loss programs, with recent mental health hospitalizations, past or planned bariatric surgery, current/planned pregnancy, breastfeeding, significant recent weight loss, or conditions that limit moderate exercise.

What is being tested?

The Ignite Pilot study tests different goal intensities in a digital weight loss program over 10 weeks without face-to-face meetings. Participants will track their food intake and steps while receiving tailored feedback and action plans. Goals vary in difficulty across four areas: calorie intake, step count, eating window duration, and limiting certain foods.

What are the potential side effects?

Since this is a non-medical intervention focusing on lifestyle changes through diet and physical activity goals set within safe limits for the general population seeking weight loss support; no direct side effects from medications or medical procedures are expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

(Acceptability) Would you recommend the weight loss program to a friend who is trying to lose weight?

(Feasibility) engagement in self-monitoring body weight

(Feasibility) engagement in self-monitoring dietary intake

+1 more

Secondary study objectives

(Feasibility) goal attainment of Red Zone Food goal

(Feasibility) goal attainment of calorie goal

(Feasibility) goal attainment of eating window goal

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

16Treatment groups

Experimental Treatment

Group I: Condition 9Experimental Treatment6 Interventions

Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)

Group II: Condition 8Experimental Treatment6 Interventions

Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)

Group III: Condition 7Experimental Treatment7 Interventions

Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)

Group IV: Condition 6Experimental Treatment6 Interventions

Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)

Group V: Condition 5Experimental Treatment5 Interventions

Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)

Group VI: Condition 4Experimental Treatment6 Interventions

Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)

Group VII: Condition 3Experimental Treatment7 Interventions

Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)

Group VIII: Condition 2Experimental Treatment6 Interventions

Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)

Group IX: Condition 16Experimental Treatment5 Interventions

Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)

Group X: Condition 15Experimental Treatment6 Interventions

Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)

Group XI: Condition 14Experimental Treatment7 Interventions

Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)

Group XII: Condition 13Experimental Treatment6 Interventions

Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)

Group XIII: Condition 12Experimental Treatment5 Interventions

Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)

Group XIV: Condition 11Experimental Treatment6 Interventions

Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)

Group XV: Condition 10Experimental Treatment7 Interventions

Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)

Group XVI: Condition 1Experimental Treatment5 Interventions

Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Harder Red Zone Food Goal

2023

N/A

~40

Easier Red Zone Food Goal

2023

N/A

~40

Core Behavioral Weight Loss Intervention

2023

N/A

~40

Easier Step Goal

2023

N/A

~40

Harder Step Goal

2023

N/A

~40

Easier Calorie Goal

2023

N/A

~40

Harder Calorie Goal

2023

N/A

~40

Easier Eating Window Goal

2023

N/A

~40

Harder Eating Window Goal

2023

N/A

~40

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for obesity, particularly those involving self-monitoring and behavioral modification, work by helping patients become more aware of their eating and activity patterns. Self-monitoring involves tracking food intake, physical activity, and body weight, which can increase accountability and highlight areas for improvement. Behavioral modification includes setting realistic goals, developing action plans, and learning coping strategies to manage high-risk situations for overeating. These mechanisms are crucial for obesity patients as they promote sustainable lifestyle changes, improve adherence to dietary and exercise regimens, and ultimately lead to effective weight loss and better overall health.