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NCT05715242
Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention
Conditions: Obesity, Overweight, Weight Loss, Health Behavior
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 32
Sponsor: Stanford University
Location: United States
Summary
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 (weight loss goal, calorie goal, step goal, and eating window 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 3 months, 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 1 month, 3 months, and 6 months.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.
Eligibility Criteria
Inclusion Criteria:adults (ages 18+ years)body mass index (BMI) 25.0 to 45.0 kg/m^2smartphone ownershipwillingness to install the Fitbit mobile app on their phoneaccess to a personal email accountEnglish language proficiencyinterest in losing weight through behavioral strategiesliving in the United StatesExclusion Criteria:concurrent enrollment in another weight management interventionloss of ≥10 lbs. in the past 6 monthscurrent use of a weight loss medicationprior or planned bariatric surgerycurrent or planned pregnancy in the trial periodcurrently breastfeedinglives with someone else participating in the studyhospitalization for a mental health condition in the past 12 monthsinability 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
Source: ClinicalTrials.gov (NCT05715242). StuddyBuddy aggregates publicly available trial information.