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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
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 moreSecondary study objectives
(Feasibility) goal attainment of Red Zone Food goal
(Feasibility) goal attainment of calorie goal
(Feasibility) goal attainment of eating window goal
+4 moreAwards & 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
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.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,462 Previous Clinical Trials
17,494,908 Total Patients Enrolled
70 Trials studying Obesity
270,162 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,432 Previous Clinical Trials
4,323,225 Total Patients Enrolled
467 Trials studying Obesity
589,467 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had or am planning to have weight loss surgery.I am 18 years old or older.I want to lose weight by changing my behaviors.I have lost 10 or more pounds in the last 6 months.I am willing to install the Fitbit app on my phone.I have a condition or take medication that makes losing weight difficult or not recommended.I cannot do moderate exercise like brisk walking.I am 18 years old or older.I have a personal email account.I am currently taking medication to lose weight.I am willing to install the Fitbit app on my phone.You own a smartphone.You possess a personal email address.You have a body mass index (BMI) between 25 and 45 kg/m^2.You are a resident of the United States.I am interested in losing weight through lifestyle changes.
Research Study Groups:
This trial has the following groups:- Group 1: Condition 7
- Group 2: Condition 1
- Group 3: Condition 2
- Group 4: Condition 3
- Group 5: Condition 4
- Group 6: Condition 5
- Group 7: Condition 6
- Group 8: Condition 8
- Group 9: Condition 9
- Group 10: Condition 10
- Group 11: Condition 11
- Group 12: Condition 12
- Group 13: Condition 13
- Group 14: Condition 14
- Group 15: Condition 15
- Group 16: Condition 16
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT05715242 — N/A
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