Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention
July 10, 2026 updated by: Michele Patel, Stanford University
Goal Setting in a Standalone, Digital Weight Loss Intervention: a Pilot Factorial Trial
The goal of this pilot trial is to learn about the optimal intensity level of goals in a digital weight loss intervention among adults with overweight or obesity. The main questions of the study are to assess the feasibility and acceptability of different goal intensities across four domains (calorie goal, step goal, eating window goal, red zone food goal).
The investigators will recruit 32 total participants to the trial. Recruitment will occur through remote channels. Interested individuals will be directed to an online screening questionnaire; those who are eligible will then be invited to attend an initial remote session with study personnel to ensure interest and eligibility in the study. The weight loss intervention will last 10 weeks, and all participants will receive a "core" treatment consisting of self-monitoring weight, food intake, and steps (all via digital tools provided by the study team), along with behavioral lessons, action plans, and tailored feedback. Depending on which group participants are assigned to in the study, individuals will receive either a more or less challenging goal across the four domains. All study tasks will occur remotely, thus, participants will never come in-person for any tasks. Assessment of body weight and other measures will occur at the beginning of the trial ("baseline"), and at 4 weeks and 10 weeks.
The investigators will use the Multiphase Optimization Strategy (MOST) framework to identify which of the goal intensity levels result in meaningful engagement and weight loss. The current study is the first step towards answering this question; it is designed as a pilot factorial trial, which focuses on feasibility and acceptability. In total, there will be 16 treatment conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Behavioral: Easier Step Goal
- Behavioral: Easier Calorie Goal
- Behavioral: Easier Eating Window Goal
- Behavioral: Harder Calorie Goal
- Behavioral: Harder Step Goal
- Behavioral: Core Behavioral Weight Loss Intervention
- Behavioral: Easier Red Zone Food Goal
- Behavioral: Harder Red Zone Food Goal
- Behavioral: Harder Eating Window Goal
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- adults (ages 18+ years)
- body mass index (BMI) 25.0 to 45.0 kg/m^2
- smartphone ownership
- willingness to install the Fitbit mobile app on their phone
- access to a personal email account
- English language proficiency
- interest in losing weight through behavioral strategies
- living in the United States
Exclusion Criteria:
- concurrent enrollment in another weight management intervention
- loss of ≥10 lbs. in the past 6 months
- current use of a weight loss medication
- prior or planned bariatric surgery
- current or planned pregnancy in the trial period
- currently breastfeeding
- lives with someone else participating in the study
- hospitalization for a mental health condition in the past 12 months
- inability to engage in moderate forms of physical activity akin to brisk walking (assessed by the Physical Activity Readiness Questionnaire)
- if weight loss is contraindicated or might be impacted by a condition or medication (e.g., end stage renal disease, cancer, schizophrenia, dementia, steroids, anti-psychotics)
- if an individual would be better suited for a more intensive or different type of intervention based on a health condition (e.g., individuals with history of an eating disorder or cardiovascular event, uncontrolled hypertension, or uncontrolled diabetes mellitus)
- investigator discretion for safety reasons
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Condition 1
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Participants will receive an easier daily step goal.
Participants will receive an easier daily calorie goal.
Participants will receive an easier daily eating window goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive an easier daily Red Zone Food goal.
|
|
Experimental: Condition 2
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Participants will receive an easier daily step goal.
Participants will receive an easier daily calorie goal.
Participants will receive an easier daily eating window goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive a more challenging daily Red Zone Food goal.
|
|
Experimental: Condition 3
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Participants will receive an easier daily step goal.
Participants will receive an easier daily calorie goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive an easier daily Red Zone Food goal.
Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.
|
|
Experimental: Condition 4
Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Participants will receive an easier daily step goal.
Participants will receive an easier daily calorie goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive a more challenging daily Red Zone Food goal.
Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.
|
|
Experimental: Condition 5
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Participants will receive an easier daily calorie goal.
Participants will receive an easier daily eating window goal.
Participants will receive a more challenging daily step goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive an easier daily Red Zone Food goal.
|
|
Experimental: Condition 6
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Participants will receive an easier daily calorie goal.
Participants will receive an easier daily eating window goal.
Participants will receive a more challenging daily step goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive a more challenging daily Red Zone Food goal.
|
|
Experimental: Condition 7
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Participants will receive an easier daily calorie goal.
Participants will receive a more challenging daily step goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive an easier daily Red Zone Food goal.
Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.
|
|
Experimental: Condition 8
Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Participants will receive an easier daily calorie goal.
Participants will receive a more challenging daily step goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive a more challenging daily Red Zone Food goal.
Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.
|
|
Experimental: Condition 9
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Participants will receive an easier daily step goal.
Participants will receive an easier daily eating window goal.
Participants will receive a more challenging daily calorie goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive an easier daily Red Zone Food goal.
|
|
Experimental: Condition 10
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Participants will receive an easier daily step goal.
Participants will receive an easier daily eating window goal.
Participants will receive a more challenging daily calorie goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive a more challenging daily Red Zone Food goal.
|
|
Experimental: Condition 11
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Participants will receive an easier daily step goal.
Participants will receive a more challenging daily calorie goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive an easier daily Red Zone Food goal.
Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.
|
|
Experimental: Condition 12
Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Participants will receive an easier daily step goal.
Participants will receive a more challenging daily calorie goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive a more challenging daily Red Zone Food goal.
Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.
|
|
Experimental: Condition 13
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)
|
Participants will receive an easier daily eating window goal.
Participants will receive a more challenging daily calorie goal.
Participants will receive a more challenging daily step goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive an easier daily Red Zone Food goal.
|
|
Experimental: Condition 14
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)
|
Participants will receive an easier daily eating window goal.
Participants will receive a more challenging daily calorie goal.
Participants will receive a more challenging daily step goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive a more challenging daily Red Zone Food goal.
|
|
Experimental: Condition 15
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)
|
Participants will receive a more challenging daily calorie goal.
Participants will receive a more challenging daily step goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive an easier daily Red Zone Food goal.
Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.
|
|
Experimental: Condition 16
Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)
|
Participants will receive a more challenging daily calorie goal.
Participants will receive a more challenging daily step goal.
All participants will receive a 10-week core behavioral weight loss treatment consisting of: self-monitoring weight, steps, and food intake; behavioral lessons; action plans; and tailored feedback.
The intervention will be delivered remotely via email and digital tools (such as a smart scale, Fitbit activity tracker, and Fitbit app).
Participants will receive a more challenging daily Red Zone Food goal.
Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
(Feasibility) Engagement in Self-monitoring Body Weight
Time Frame: baseline to 10 weeks
|
average percentage of days in the 10-week intervention of self-monitoring weight (assessed objectively via smart scale); a benchmark of self-monitoring 75% of days would indicate feasibility
|
baseline to 10 weeks
|
|
(Feasibility) Engagement in Self-monitoring Steps
Time Frame: baseline to 10 weeks
|
average percentage of days in the 10-week intervention of self-monitoring steps (assessed objectively via Fitbit activity tracker); a benchmark of self-monitoring 75% of days would indicate feasibility
|
baseline to 10 weeks
|
|
(Feasibility) Engagement in Self-monitoring Dietary Intake
Time Frame: baseline to 10 weeks
|
average percentage of days in the 10-week intervention of self-monitoring dietary intake (assessed via Fitbit mobile app); a benchmark of self-monitoring 75% of days would indicate feasibility
|
baseline to 10 weeks
|
|
(Acceptability) Would You Recommend the Weight Loss Program to a Friend Who is Trying to Lose Weight?
Time Frame: 10 weeks
|
1-item measure; a benchmark of 80% of participants answering "yes" would indicate acceptability
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
(Feasibility) Retention Rate
Time Frame: 10 weeks
|
the proportion of participants who submitted a weight entry at 10 weeks; a benchmark of 80% would indicate feasibility
|
10 weeks
|
|
(Feasibility) Survey Completion Rate
Time Frame: baseline; 10 weeks
|
the proportion of participants who completed the web survey; a benchmark of 80% would indicate feasibility
|
baseline; 10 weeks
|
|
(Feasibility) Goal Attainment of Calorie Goal
Time Frame: baseline to 10 weeks
|
average percentage of days in the 10-week intervention of meeting the daily calorie goal (assessed via Fitbit mobile app); a benchmark of 75% of days would indicate feasibility
|
baseline to 10 weeks
|
|
(Feasibility) Goal Attainment of Step Goal
Time Frame: baseline to 10 weeks
|
average percentage of days in the 10-week intervention of meeting the daily step goal (assessed via Fitbit activity tracker); a benchmark of 75% of days would indicate feasibility
|
baseline to 10 weeks
|
|
(Feasibility) Goal Attainment of Eating Window Goal
Time Frame: baseline to 10 weeks
|
average percentage of days in the 10-week intervention of meeting the daily eating window goal (assessed via survey); a benchmark of 75% of days would indicate feasibility
|
baseline to 10 weeks
|
|
(Feasibility) Goal Attainment of Red Zone Food Goal
Time Frame: baseline to 10 weeks
|
average percentage of days (out of days instructed to track Red Zone Foods) in the 10-week intervention of meeting the daily Red Zone Food goal (assessed via survey); a benchmark of 75% of weeks would indicate feasibility
|
baseline to 10 weeks
|
|
Weight
Time Frame: baseline to 10 weeks
|
percentage change in weight from baseline to 10 weeks (end of intervention); assessed objectively via smart scale
|
baseline to 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2023
Primary Completion (Actual)
April 9, 2024
Study Completion (Actual)
April 14, 2024
Study Registration Dates
First Submitted
January 27, 2023
First Submitted That Met QC Criteria
January 27, 2023
First Posted (Actual)
February 6, 2023
Study Record Updates
Last Update Posted (Actual)
August 5, 2026
Last Update Submitted That Met QC Criteria
July 10, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 68892
- P30DK116074 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.