NCT05715242

Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (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.

Conditions

• Obesity
• Overweight
• Weight Loss
• Health Behavior

Interventions

Type	Name	Description
BEHAVIORAL	Core Behavioral Weight Loss Intervention	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).
BEHAVIORAL	Easier Step Goal	Participants will receive an easier daily step goal.
BEHAVIORAL	Harder Step Goal	Participants will receive a more challenging daily step goal.
BEHAVIORAL	Easier Calorie Goal	Participants will receive an easier daily calorie goal.
BEHAVIORAL	Harder Calorie Goal	Participants will receive a more challenging daily calorie goal.
BEHAVIORAL	Easier Eating Window Goal	Participants will receive an easier daily eating window goal.
BEHAVIORAL	Harder Eating Window Goal	Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.
BEHAVIORAL	Easier Red Zone Food Goal	Participants will receive an easier daily Red Zone Food goal.
BEHAVIORAL	Harder Red Zone Food Goal	Participants will receive a more challenging daily Red Zone Food goal.

Timeline

• Start date: 2023-12-05
• Primary completion: 2024-04-09
• Completion: 2024-04-14
• First posted: 2023-02-06
• Last updated: 2025-05-16
• Results posted: 2025-05-16

Locations

1 site across 1 country: United States