Clinical trial NCT05715242: Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention
Official title: Goal Setting in a Standalone, Digital Weight Loss Intervention: a Pilot Factorial Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Weight Loss
Health Behavior
Keywords: weight loss
Multiphase Optimization Strategy
behavioral intervention
factorial trial
goal setting
time-restricted eating
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-02-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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).
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: (Feasibility) Engagement in Self-monitoring Body Weight
timeFrame: baseline to 10 weeks
measure: (Feasibility) Engagement in Self-monitoring Steps
timeFrame: baseline to 10 weeks
measure: (Feasibility) Engagement in Self-monitoring Dietary Intake
timeFrame: baseline to 10 weeks
measure: (Acceptability) Would You Recommend the Weight Loss Program to a Friend Who is Trying to Lose Weight?
timeFrame: 10 weeks
Secondary outcomes:
measure: (Feasibility) Retention Rate
timeFrame: 10 weeks
measure: (Feasibility) Survey Completion Rate
timeFrame: baseline; 10 weeks
measure: (Feasibility) Goal Attainment of Calorie Goal
timeFrame: baseline to 10 weeks
measure: (Feasibility) Goal Attainment of Step Goal
timeFrame: baseline to 10 weeks
measure: (Feasibility) Goal Attainment of Eating Window Goal
timeFrame: baseline to 10 weeks
measure: (Feasibility) Goal Attainment of Red Zone Food Goal
timeFrame: baseline to 10 weeks
measure: Weight
timeFrame: baseline to 10 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References: