Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention

Trial ID or NCT#

NCT05715242

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Goal Setting in a Standalone, Digital Weight Loss Intervention: a Pilot Factorial Trial

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Michele Lanpher Patel

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Contact

Michele L Patel, PhD
650-549-7047