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Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention
Recruiting
I'm InterestedTrial ID: NCT05249465
Purpose
This optimization trial will examine three tracking (or "self-monitoring") strategies for
weight loss -- tracking dietary intake, steps, and/or body weight -- all delivered through
digital health tools. The purpose of the study is to evaluate the combination of these
strategies that maximizes 6-month weight loss in the context of a standalone digital health
intervention for adults with overweight or obesity.
The investigators will recruit 176 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 6 months, and all participants will receive a "core" treatment
consisting of goal setting, behavioral lessons, action plans, and tailored feedback - all of
which will be delivered remotely. Depending on which group participants are assigned to in
the study, some individuals will be asked to track their dietary intake, their steps, and/or
their body weight via digital tools. All study tasks will occur remotely, thus, participants
never need to come in-person for any intervention or assessment tasks.
The investigators will use the Multiphase Optimization Strategy (MOST) framework to identify
the most effective combination of self-monitoring strategies. The factorial design will allow
the research team to determine the unique and combined impact of each self-monitoring
component on weight change. The primary outcome is weight change from baseline to 6 months.
The research team will also assess self-monitoring engagement over 6 months and its
association with weight change. To complement the main trial, the research team will also
randomize half of participants to receive an interactive orientation video, in order to
assess its impact on trial retention at 6 months. Overall, the information gathered from this
trial will enable the construction of an optimized digital health intervention for weight
loss that can be delivered remotely, which, if found to be effective, could have high
potential for scalability.
Official Title
Optimizing Self-monitoring in a Digital Health Intervention for Weight Loss
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- adults (ages 18+ years)
- body mass index (BMI) 25.0 to 45.0 kg/m^2
- smartphone ownership
- willingness to install a mobile app on their phone
- access to a personal email account
- English language proficiency
- interest in losing weight through behavioral strategies
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
Intervention(s):
behavioral: Core behavioral weight loss intervention
behavioral: Self-monitoring diet
behavioral: Self-monitoring weight
behavioral: Self-monitoring steps
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michele L Patel, PhD
650-549-7047