NCT05715242Completed
Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention
Goal Setting in a Standalone, Digital Weight Loss Intervention: a Pilot Factorial Trial
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 32 (actual)
- First submitted
- 27 Jan 2023
- Start date
- 5 Dec 2023
- Primary completion date
- 9 Apr 2024
- Lead sponsor
- Stanford University
- Diseases
- Obesity
- NCT number
- NCT05715242
What you commit to
- Study type: Interventional
- Participants enrolled: 32
- From 5 Dec 2023 to the primary completion date, 9 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- concurrent enrollment in another weight management intervention
- current use of a weight loss medication
- prior or planned bariatric surgery
Other illness
- hospitalization for a mental health condition in the past 12 months
- 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)
Other
- loss of ≥10 lbs. in the past 6 months
- current or planned pregnancy in the trial period
- currently breastfeeding
- lives with someone else participating in the study
- inability to engage in moderate forms of physical activity akin to brisk walking (assessed by the Physical Activity Readiness Questionnaire)
- investigator discretion for safety reasons
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University, School of Medicine Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
Related publications
- Optimizing Goal Difficulty in a Digital Weight Loss Intervention: The Ignite Pilot Randomized Trial.Obes Sci Pract · 2026 · PMID 42473633
This page is information, not medical advice. Discuss any trial with your doctor.