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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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).
Participants will receive an easier daily step goal.
Participants will receive a more challenging daily step goal.
Participants will receive an easier daily calorie goal.
Participants will receive a more challenging daily calorie goal.
Participants will receive an easier daily eating window goal.
Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.
Participants will receive an easier daily Red Zone Food goal.
Participants will receive a more challenging daily Red Zone Food goal.
Stanford University School of Medicine
Palo Alto, California, United States
(Feasibility) Engagement in Self-monitoring Body Weight
average percentage of days in the 10-week intervention of self-monitoring weight (assessed objectively via smart scale); a benchmark of self-monitoring 75% of days would indicate feasibility
Time frame: baseline to 10 weeks
(Feasibility) Engagement in Self-monitoring Steps
average percentage of days in the 10-week intervention of self-monitoring steps (assessed objectively via Fitbit activity tracker); a benchmark of self-monitoring 75% of days would indicate feasibility
Time frame: baseline to 10 weeks
(Feasibility) Engagement in Self-monitoring Dietary Intake
average percentage of days in the 10-week intervention of self-monitoring dietary intake (assessed via Fitbit mobile app); a benchmark of self-monitoring 75% of days would indicate feasibility
Time frame: baseline to 10 weeks
(Acceptability) Would You Recommend the Weight Loss Program to a Friend Who is Trying to Lose Weight?
1-item measure; a benchmark of 80% of participants answering "yes" would indicate acceptability
Time frame: 10 weeks
(Feasibility) Retention Rate
the proportion of participants who submitted a weight entry at 10 weeks; a benchmark of 80% would indicate feasibility
Time frame: 10 weeks
(Feasibility) Survey Completion Rate
the proportion of participants who completed the web survey; a benchmark of 80% would indicate feasibility
Time frame: baseline; 10 weeks
(Feasibility) Goal Attainment of Calorie Goal
average percentage of days in the 10-week intervention of meeting the daily calorie goal (assessed via Fitbit mobile app); a benchmark of 75% of days would indicate feasibility
Time frame: baseline to 10 weeks
(Feasibility) Goal Attainment of Step Goal
average percentage of days in the 10-week intervention of meeting the daily step goal (assessed via Fitbit activity tracker); a benchmark of 75% of days would indicate feasibility
Time frame: baseline to 10 weeks
(Feasibility) Goal Attainment of Eating Window Goal
average percentage of days in the 10-week intervention of meeting the daily eating window goal (assessed via survey); a benchmark of 75% of days would indicate feasibility
Time frame: baseline to 10 weeks
(Feasibility) Goal Attainment of Red Zone Food Goal
average percentage of days (out of days instructed to track Red Zone Foods) in the 10-week intervention of meeting the daily Red Zone Food goal (assessed via survey); a benchmark of 75% of weeks would indicate feasibility
Time frame: baseline to 10 weeks
Weight
percentage change in weight from baseline to 10 weeks (end of intervention); assessed objectively via smart scale
Time frame: baseline to 10 weeks
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