Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention

Not Applicable

Completed

Conditions: Obesity
Weight Loss
Overweight
Health Behavior

Registration Number: NCT05715242

Lead Sponsor: Stanford University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
(Feasibility) Engagement in Self-monitoring Body Weight	baseline to 10 weeks	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
(Feasibility) Engagement in Self-monitoring Steps	baseline to 10 weeks	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
(Feasibility) Engagement in Self-monitoring Dietary Intake	baseline to 10 weeks	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
(Acceptability) Would You Recommend the Weight Loss Program to a Friend Who is Trying to Lose Weight?	10 weeks	1-item measure; a benchmark of 80% of participants answering "yes" would indicate acceptability

Secondary Outcome Measures

Name	Time	Method
(Feasibility) Retention Rate	10 weeks	the proportion of participants who submitted a weight entry at 10 weeks; a benchmark of 80% would indicate feasibility
(Feasibility) Survey Completion Rate	baseline; 10 weeks	the proportion of participants who completed the web survey; a benchmark of 80% would indicate feasibility
(Feasibility) Goal Attainment of Calorie Goal	baseline to 10 weeks	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
(Feasibility) Goal Attainment of Step Goal	baseline to 10 weeks	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
(Feasibility) Goal Attainment of Eating Window Goal	baseline to 10 weeks	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
(Feasibility) Goal Attainment of Red Zone Food Goal	baseline to 10 weeks	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
Weight	baseline to 10 weeks	percentage change in weight from baseline to 10 weeks (end of intervention); assessed objectively via smart scale

Trial Locations

Locations (1): Stanford University School of Medicine
🇺🇸
Palo Alto, California, United States
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States