Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention

NCT05715242 | Completed Results

• 2 other identifiers: 68892P30DK116074
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 (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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• (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 Outcomes (7)

• (Feasibility) Retention Rate

  10 weeks

• (Feasibility) Survey Completion Rate

  baseline; 10 weeks

• (Feasibility) Goal Attainment of Calorie Goal

  baseline to 10 weeks

• (Feasibility) Goal Attainment of Step Goal

  baseline to 10 weeks

• (Feasibility) Goal Attainment of Eating Window Goal

  baseline to 10 weeks

Study Arms (16)

Condition 1

EXPERIMENTAL

Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Easier Step Goal; Behavioral: Easier Calorie Goal; Behavioral: Easier Eating Window Goal; Behavioral: Easier Red Zone Food Goal

Condition 2

EXPERIMENTAL

Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)

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

Condition 3

EXPERIMENTAL

Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)

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

Condition 4

EXPERIMENTAL

Calorie Goal (easier) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)

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

Condition 5

EXPERIMENTAL

Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)

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

Condition 6

EXPERIMENTAL

Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)

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

Condition 7

EXPERIMENTAL

Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)

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

Condition 8

EXPERIMENTAL

Calorie Goal (easier) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)

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

Condition 9

EXPERIMENTAL

Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (easier)

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

Condition 10

EXPERIMENTAL

Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (easier) + Red Zone Food Goal (harder)

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

Condition 11

EXPERIMENTAL

Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (easier)

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

Condition 12

EXPERIMENTAL

Calorie Goal (harder) + Step Goal (easier) + Eating Window Goal (harder) + Red Zone Food Goal (harder)

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

Condition 13

EXPERIMENTAL

Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (easier)

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

Condition 14

EXPERIMENTAL

Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (easier) + Red Zone Food Goal (harder)

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

Condition 15

EXPERIMENTAL

Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (easier)

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

Condition 16

EXPERIMENTAL

Calorie Goal (harder) + Step Goal (harder) + Eating Window Goal (harder) + Red Zone Food Goal (harder)

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Harder Step Goal; Behavioral: Harder Calorie Goal; Behavioral: Harder Eating Window Goal; Behavioral: Harder Red Zone Food Goal

Interventions

Core Behavioral Weight Loss Intervention BEHAVIORAL

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).

Condition 1; Condition 10; Condition 11; Condition 12; Condition 13; Condition 14; Condition 15; Condition 16; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8; Condition 9

Easier Step Goal BEHAVIORAL

Participants will receive an easier daily step goal.

Condition 1; Condition 10; Condition 11; Condition 12; Condition 2; Condition 3; Condition 4; Condition 9

Harder Step Goal BEHAVIORAL

Participants will receive a more challenging daily step goal.

Condition 13; Condition 14; Condition 15; Condition 16; Condition 5; Condition 6; Condition 7; Condition 8

Easier Calorie Goal BEHAVIORAL

Participants will receive an easier daily calorie goal.

Condition 1; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8

Harder Calorie Goal BEHAVIORAL

Participants will receive a more challenging daily calorie goal.

Condition 10; Condition 11; Condition 12; Condition 13; Condition 14; Condition 15; Condition 16; Condition 9

Easier Eating Window Goal BEHAVIORAL

Participants will receive an easier daily eating window goal.

Condition 1; Condition 10; Condition 13; Condition 14; Condition 2; Condition 5; Condition 6; Condition 9

Harder Eating Window Goal BEHAVIORAL

Participants will receive a more challenging daily eating window goal, akin to time-restricted eating.

Condition 11; Condition 12; Condition 15; Condition 16; Condition 3; Condition 4; Condition 7; Condition 8

Easier Red Zone Food Goal BEHAVIORAL

Participants will receive an easier daily Red Zone Food goal.

Condition 1; Condition 11; Condition 13; Condition 15; Condition 3; Condition 5; Condition 7; Condition 9

Harder Red Zone Food Goal BEHAVIORAL

Participants will receive a more challenging daily Red Zone Food goal.

Condition 10; Condition 12; Condition 14; Condition 16; Condition 2; Condition 4; Condition 6; Condition 8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Health Behavior; Intermittent Fasting

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior; Fasting; Feeding Behavior

Results Point of Contact

• Title: Michele L. Patel, PhD
• Organization: Stanford University School of Medicine

michele.patel@stanford.edu

650-549-7047

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Model Details: This study uses a full factorial experimental design to test the impact of four intervention components, each with two levels (i.e., a 2x2x2x2).

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: December 5, 2023
• Primary Completion: April 9, 2024
• Study Completion: April 14, 2024
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)