Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention

Study Overview
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Brief Summary
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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
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Goal Setting in a Standalone, Digital Weight Loss Intervention: a Pilot Factorial Trial

Conditions
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Obesity, Overweight, Weight Loss, Health Behavior

Intervention / Treatment
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* Behavioral: Core Behavioral Weight Loss Intervention
* Behavioral: Easier Step Goal
* Behavioral: Harder Step Goal
* Behavioral: Easier Calorie Goal
* Behavioral: Harder Calorie Goal
* Behavioral: Easier Eating Window Goal
* Behavioral: Harder Eating Window Goal
* Behavioral: Easier Red Zone Food Goal
* Behavioral: Harder Red Zone Food Goal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: This study uses a full factorial experimental design to test the impact of four intervention components, each with two levels (i.e., a 2x2x2x2).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition 1<br>Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Easier Step Goal<br>* Participants will receive an easier daily step goal.<br>Behavioral: Easier Calorie Goal<br>* Participants will receive an easier daily calorie goal.<br>Behavioral: Easier Eating Window Goal<br>* Participants will receive an easier daily eating window goal.<br>Behavioral: Easier Red Zone Food Goal<br>* Participants will receive an easier daily Red Zone Food goal.<br>|
| Experimental: Condition 2<br>Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Easier Step Goal<br>* Participants will receive an easier daily step goal.<br>Behavioral: Easier Calorie Goal<br>* Participants will receive an easier daily calorie goal.<br>Behavioral: Easier Eating Window Goal<br>* Participants will receive an easier daily eating window goal.<br>Behavioral: Harder Red Zone Food Goal<br>* Participants will receive a more challenging daily Red Zone Food goal.<br>|
| Experimental: Condition 3<br>Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Easier Step Goal<br>* Participants will receive an easier daily step goal.<br>Behavioral: Easier Calorie Goal<br>* Participants will receive an easier daily calorie goal.<br>Behavioral: Harder Eating Window Goal<br>* Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.<br>Behavioral: Easier Red Zone Food Goal<br>* Participants will receive an easier daily Red Zone Food goal.<br>|
| Experimental: Condition 4<br>Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Easier Step Goal<br>* Participants will receive an easier daily step goal.<br>Behavioral: Easier Calorie Goal<br>* Participants will receive an easier daily calorie goal.<br>Behavioral: Harder Eating Window Goal<br>* Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.<br>Behavioral: Harder Red Zone Food Goal<br>* Participants will receive a more challenging daily Red Zone Food goal.<br>|
| Experimental: Condition 5<br>Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Harder Step Goal<br>* Participants will receive a more challenging daily step goal.<br>Behavioral: Easier Calorie Goal<br>* Participants will receive an easier daily calorie goal.<br>Behavioral: Easier Eating Window Goal<br>* Participants will receive an easier daily eating window goal.<br>Behavioral: Easier Red Zone Food Goal<br>* Participants will receive an easier daily Red Zone Food goal.<br>|
| Experimental: Condition 6<br>Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Harder Step Goal<br>* Participants will receive a more challenging daily step goal.<br>Behavioral: Easier Calorie Goal<br>* Participants will receive an easier daily calorie goal.<br>Behavioral: Easier Eating Window Goal<br>* Participants will receive an easier daily eating window goal.<br>Behavioral: Harder Red Zone Food Goal<br>* Participants will receive a more challenging daily Red Zone Food goal.<br>|
| Experimental: Condition 7<br>Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Harder Step Goal<br>* Participants will receive a more challenging daily step goal.<br>Behavioral: Easier Calorie Goal<br>* Participants will receive an easier daily calorie goal.<br>Behavioral: Harder Eating Window Goal<br>* Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.<br>Behavioral: Easier Red Zone Food Goal<br>* Participants will receive an easier daily Red Zone Food goal.<br>|
| Experimental: Condition 8<br>Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Harder Step Goal<br>* Participants will receive a more challenging daily step goal.<br>Behavioral: Easier Calorie Goal<br>* Participants will receive an easier daily calorie goal.<br>Behavioral: Harder Eating Window Goal<br>* Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.<br>Behavioral: Harder Red Zone Food Goal<br>* Participants will receive a more challenging daily Red Zone Food goal.<br>|
| Experimental: Condition 9<br>Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Easier Step Goal<br>* Participants will receive an easier daily step goal.<br>Behavioral: Harder Calorie Goal<br>* Participants will receive a more challenging daily calorie goal.<br>Behavioral: Easier Eating Window Goal<br>* Participants will receive an easier daily eating window goal.<br>Behavioral: Easier Red Zone Food Goal<br>* Participants will receive an easier daily Red Zone Food goal.<br>|
| Experimental: Condition 10<br>Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Easier Step Goal<br>* Participants will receive an easier daily step goal.<br>Behavioral: Harder Calorie Goal<br>* Participants will receive a more challenging daily calorie goal.<br>Behavioral: Easier Eating Window Goal<br>* Participants will receive an easier daily eating window goal.<br>Behavioral: Harder Red Zone Food Goal<br>* Participants will receive a more challenging daily Red Zone Food goal.<br>|
| Experimental: Condition 11<br>Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Easier Step Goal<br>* Participants will receive an easier daily step goal.<br>Behavioral: Harder Calorie Goal<br>* Participants will receive a more challenging daily calorie goal.<br>Behavioral: Harder Eating Window Goal<br>* Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.<br>Behavioral: Easier Red Zone Food Goal<br>* Participants will receive an easier daily Red Zone Food goal.<br>|
| Experimental: Condition 12<br>Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Easier Step Goal<br>* Participants will receive an easier daily step goal.<br>Behavioral: Harder Calorie Goal<br>* Participants will receive a more challenging daily calorie goal.<br>Behavioral: Harder Eating Window Goal<br>* Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.<br>Behavioral: Harder Red Zone Food Goal<br>* Participants will receive a more challenging daily Red Zone Food goal.<br>|
| Experimental: Condition 13<br>Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Harder Step Goal<br>* Participants will receive a more challenging daily step goal.<br>Behavioral: Harder Calorie Goal<br>* Participants will receive a more challenging daily calorie goal.<br>Behavioral: Easier Eating Window Goal<br>* Participants will receive an easier daily eating window goal.<br>Behavioral: Easier Red Zone Food Goal<br>* Participants will receive an easier daily Red Zone Food goal.<br>|
| Experimental: Condition 14<br>Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Harder Step Goal<br>* Participants will receive a more challenging daily step goal.<br>Behavioral: Harder Calorie Goal<br>* Participants will receive a more challenging daily calorie goal.<br>Behavioral: Easier Eating Window Goal<br>* Participants will receive an easier daily eating window goal.<br>Behavioral: Harder Red Zone Food Goal<br>* Participants will receive a more challenging daily Red Zone Food goal.<br>|
| Experimental: Condition 15<br>Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Harder Step Goal<br>* Participants will receive a more challenging daily step goal.<br>Behavioral: Harder Calorie Goal<br>* Participants will receive a more challenging daily calorie goal.<br>Behavioral: Harder Eating Window Goal<br>* Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.<br>Behavioral: Easier Red Zone Food Goal<br>* Participants will receive an easier daily Red Zone Food goal.<br>|
| Experimental: Condition 16<br>Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder) | Behavioral: Core Behavioral Weight Loss Intervention<br>* 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).<br>Behavioral: Harder Step Goal<br>* Participants will receive a more challenging daily step goal.<br>Behavioral: Harder Calorie Goal<br>* Participants will receive a more challenging daily calorie goal.<br>Behavioral: Harder Eating Window Goal<br>* Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.<br>Behavioral: Harder Red Zone Food Goal<br>* Participants will receive a more challenging daily Red Zone Food goal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (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 | 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 | 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 | 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 | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Feasibility) retention rate | the proportion of participants who submitted a weight entry at 10 weeks; a benchmark of 80% would indicate feasibility | 10 weeks | 
| (Feasibility) survey completion rate | the proportion of participants who completed the web survey; a benchmark of 80% would indicate feasibility | 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 | 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 | 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 | baseline to 10 weeks | 
| (Feasibility) goal attainment of Red Zone Food goal | average percentage of weeks in the 10-week intervention of meeting the weekly Red Zone Food goal (assessed via survey); a benchmark of 75% of weeks would indicate feasibility | baseline to 10 weeks | 
| weight | change in weight from baseline to 10-week (end of intervention); assessed objectively via smart scale | baseline to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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factorial trial, weight loss, Multiphase Optimization Strategy, behavioral intervention, goal setting, time-restricted eating