Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention

• ClinicalTrials.gov Identifier: NCT05715242
• Recruitment Status: Not yet recruiting
• First Posted: February 6, 2023
• Last Update Posted: February 8, 2023
• Sponsor: Stanford University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Michele Patel, Stanford University

Study Description

Brief 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 (weight loss goal, calorie goal, step goal, and eating window 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 3 months, 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 1 month, 3 months, and 6 months.

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Overweight; Weight Loss; Health Behavior	Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Easier Weight Loss Goal; Behavioral: Harder Weight Loss Goal; 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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: Goal Setting in a Standalone, Digital Weight Loss Intervention: a Pilot Factorial Trial
• Estimated Study Start Date: March 2023
• Estimated Primary Completion Date: August 2023
• Estimated Study Completion Date: November 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Condition 1; Weight Loss Goal (easier) + Step Goal (easier) + Calorie Goal (easier) + Eating Window Goal (easier)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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 Weight Loss Goal; Participants will receive an easier 3-month weight loss goal.; Behavioral: Easier Step Goal; Participants will receive an easier daily step goal.; Behavioral: Easier Calorie Goal; Participants will receive an easier daily calorie goal.; Behavioral: Easier Eating Window Goal; Participants will receive an easier daily eating window goal.
Experimental: Condition 2; Weight Loss Goal (easier) + Step Goal (easier) + Calorie Goal (easier) + Eating Window Goal (harder)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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 Weight Loss Goal; Participants will receive an easier 3-month weight loss goal.; Behavioral: Easier Step Goal; Participants will receive an easier daily step goal.; Behavioral: Easier Calorie Goal; Participants will receive an easier daily calorie goal.; Behavioral: Harder Eating Window Goal; Participants will receive a more challenging daily eating window goal.
Experimental: Condition 3; Weight Loss Goal (easier) + Step Goal (easier) + Calorie Goal (harder) + Eating Window Goal (easier)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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 Weight Loss Goal; Participants will receive an easier 3-month weight loss goal.; Behavioral: Easier Step Goal; Participants will receive an easier daily step 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.
Experimental: Condition 4; Weight Loss Goal (easier) + Step Goal (easier) + Calorie Goal (harder) + Eating Window Goal (harder)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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 Weight Loss Goal; Participants will receive an easier 3-month weight loss goal.; Behavioral: Easier Step Goal; Participants will receive an easier daily step goal.; Behavioral: Harder Calorie Goal; Participants will receive a more challenging daily calorie goal.; Behavioral: Harder Eating Window Goal; Participants will receive a more challenging daily eating window goal.
Experimental: Condition 5; Weight Loss Goal (easier) + Step Goal (harder) + Calorie Goal (easier) + Eating Window Goal (easier)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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 Weight Loss Goal; Participants will receive an easier 3-month weight loss 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: Easier Eating Window Goal; Participants will receive an easier daily eating window goal.
Experimental: Condition 6; Weight Loss Goal (easier) + Step Goal (harder) + Calorie Goal (easier) + Eating Window Goal (harder)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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 Weight Loss Goal; Participants will receive an easier 3-month weight loss 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 Eating Window Goal; Participants will receive a more challenging daily eating window goal.
Experimental: Condition 7; Weight Loss Goal (easier) + Step Goal (harder) + Calorie Goal (harder) + Eating Window Goal (easier)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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 Weight Loss Goal; Participants will receive an easier 3-month weight loss goal.; Behavioral: Harder Step Goal; Participants will receive a more challenging daily step 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.
Experimental: Condition 8; Weight Loss Goal (easier) + Step Goal (harder) + Calorie Goal (harder) + Eating Window Goal (harder)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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 Weight Loss Goal; Participants will receive an easier 3-month weight loss goal.; Behavioral: Harder Step Goal; Participants will receive a more challenging daily step goal.; Behavioral: Harder Calorie Goal; Participants will receive a more challenging daily calorie goal.; Behavioral: Harder Eating Window Goal; Participants will receive a more challenging daily eating window goal.
Experimental: Condition 9; Weight Loss Goal (harder) + Step Goal (easier) + Calorie Goal (easier) + Eating Window Goal (easier)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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: Harder Weight Loss Goal; Participants will receive a more challenging 3-month weight loss goal.; Behavioral: Easier Step Goal; Participants will receive an easier daily step goal.; Behavioral: Easier Calorie Goal; Participants will receive an easier daily calorie goal.; Behavioral: Easier Eating Window Goal; Participants will receive an easier daily eating window goal.
Experimental: Condition 10; Weight Loss Goal (harder) + Step Goal (easier) + Calorie Goal (easier) + Eating Window Goal (harder)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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: Harder Weight Loss Goal; Participants will receive a more challenging 3-month weight loss goal.; Behavioral: Easier Step Goal; Participants will receive an easier daily step goal.; Behavioral: Easier Calorie Goal; Participants will receive an easier daily calorie goal.; Behavioral: Harder Eating Window Goal; Participants will receive a more challenging daily eating window goal.
Experimental: Condition 11; Weight Loss Goal (harder) + Step Goal (easier) + Calorie Goal (harder) + Eating Window Goal (easier)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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: Harder Weight Loss Goal; Participants will receive a more challenging 3-month weight loss goal.; Behavioral: Easier Step Goal; Participants will receive an easier daily step 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.
Experimental: Condition 12; Weight Loss Goal (harder) + Step Goal (easier) + Calorie Goal (harder) + Eating Window Goal (harder)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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: Harder Weight Loss Goal; Participants will receive a more challenging 3-month weight loss goal.; Behavioral: Easier Step Goal; Participants will receive an easier daily step goal.; Behavioral: Harder Calorie Goal; Participants will receive a more challenging daily calorie goal.; Behavioral: Harder Eating Window Goal; Participants will receive a more challenging daily eating window goal.
Experimental: Condition 13; Weight Loss Goal (harder) + Step Goal (harder) + Calorie Goal (easier) + Eating Window Goal (easier)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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: Harder Weight Loss Goal; Participants will receive a more challenging 3-month weight loss 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: Easier Eating Window Goal; Participants will receive an easier daily eating window goal.
Experimental: Condition 14; Weight Loss Goal (harder) + Step Goal (harder) + Calorie Goal (easier) + Eating Window Goal (harder)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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: Harder Weight Loss Goal; Participants will receive a more challenging 3-month weight loss 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 Eating Window Goal; Participants will receive a more challenging daily eating window goal.
Experimental: Condition 15; Weight Loss Goal (harder) + Step Goal (harder) + Calorie Goal (harder) + Eating Window Goal (easier)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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: Harder Weight Loss Goal; Participants will receive a more challenging 3-month weight loss goal.; Behavioral: Harder Step Goal; Participants will receive a more challenging daily step 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.
Experimental: Condition 16; Weight Loss Goal (harder) + Step Goal (harder) + Calorie Goal (harder) + Eating Window Goal (harder)	Behavioral: Core Behavioral Weight Loss Intervention; All participants will receive a 3-month 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: Harder Weight Loss Goal; Participants will receive a more challenging 3-month weight loss goal.; Behavioral: Harder Step Goal; Participants will receive a more challenging daily step goal.; Behavioral: Harder Calorie Goal; Participants will receive a more challenging daily calorie goal.; Behavioral: Harder Eating Window Goal; Participants will receive a more challenging daily eating window goal.

Outcome Measures

Primary Outcome Measures :

1. (Feasibility) engagement in self-monitoring body weight [ Time Frame: baseline to 3 months ]
   average percentage of days in the 3-month intervention of self-monitoring weight (assessed objectively via smart scale); a benchmark of self-monitoring 75% of days would indicate feasibility
2. (Feasibility) engagement in self-monitoring steps [ Time Frame: baseline to 3 months ]
   average percentage of days in the 3-month intervention of self-monitoring steps (assessed objectively via Fitbit activity tracker); a benchmark of self-monitoring 75% of days would indicate feasibility
3. (Feasibility) engagement in self-monitoring dietary intake [ Time Frame: baseline to 3 months ]
   average percentage of days in the 3-month intervention of self-monitoring dietary intake (assessed via Fitbit mobile app); a benchmark of self-monitoring 75% of days would indicate feasibility
4. (Acceptability) Would you recommend the weight loss program to a friend who is trying to lose weight? [ Time Frame: 3 months ]
   1-item measure; a benchmark of 80% of participants answering "yes" would indicate acceptability

Secondary Outcome Measures :

1. (Feasibility) retention rate [ Time Frame: 3 months ]
   the proportion of participants who submitted a weight entry at 3 months; a benchmark of 80% would indicate feasibility
2. (Feasibility) survey completion rate [ Time Frame: baseline; 3 months; 6 months ]
   the proportion of participants who completed the web survey; a benchmark of 80% would indicate feasibility
3. (Feasibility) goal attainment of weight goal [ Time Frame: baseline to 3 months ]
   average percentage of weeks in the 3-month intervention of meeting the weekly weight loss goal (assessed via smart scale); a benchmark of 75% of weeks would indicate feasibility
4. (Feasibility) goal attainment of step goal [ Time Frame: baseline to 3 months ]
   average percentage of days in the 3-month intervention of meeting the daily step goal (assessed via Fitbit activity tracker); a benchmark of 75% of days would indicate feasibility
5. (Feasibility) goal attainment of calorie goal [ Time Frame: baseline to 3 months ]
   average percentage of days in the 3-month intervention of meeting the daily calorie goal (assessed via Fitbit mobile app); a benchmark of 75% of days would indicate feasibility
6. (Feasibility) goal attainment of eating window goal [ Time Frame: baseline to 3 months ]
   average percentage of days in the 3-month intervention of meeting the daily eating window goal (assessed via survey); a benchmark of 75% of days would indicate feasibility
7. weight [ Time Frame: baseline to 3 months ]
   change in weight from baseline to 3 months (end of intervention); assessed objectively via smart scale
8. weight [ Time Frame: baseline to 6 months ]
   change in weight from baseline to 6 months (followup); assessed objectively via smart scale

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Michele L Patel, PhD; 650-549-7047; michele.patel@stanford.edu

Locations

United States, California

Stanford University School of Medicine

Palo Alto, California, United States, 94304

Principal Investigator: Michele L Patel, PhD

Sponsors and Collaborators

Stanford University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

• Responsible Party: Michele Patel, Instructor of Medicine, Stanford University
• ClinicalTrials.gov Identifier: NCT05715242
• Other Study ID Numbers: 68892; P30DK116074 ( U.S. NIH Grant/Contract )
• First Posted: February 6, 2023
• Last Update Posted: February 8, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michele Patel, Stanford University:

weight loss; Multiphase Optimization Strategy; behavioral intervention; factorial trial; goal setting; time-restricted eating

Additional relevant MeSH terms:

Body Weight; Overweight; Weight Loss; Body Weight Changes