Reset: Enhancing Weight Loss in a Digital Intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
The goal of the Reset trial is to learn about the optimal combination of dietary behavior strategies in a fully digital weight loss intervention. The intervention is designed for adults with overweight or obesity. The investigators will examine the impact on weight loss of four dietary strategies: 1) limiting Red Zone Foods (i.e., foods that are high in calories and low in nutrition), 2) limiting eating windows, 3) increasing protein intake, and 4) increasing fiber intake. Each of these strategies will include goal setting, daily self-monitoring, and tailored feedback.
The investigators will recruit 208 participants. Broadly, adults with overweight or obesity who live in the U.S. will be eligible. The weight loss intervention will last 12 weeks. All participants will be asked to track their body weight daily and complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1 month and 3 months.
The Multiphase Optimization Strategy (MOST) framework will be used to identify which combination of the dietary behavior strategies results in the greatest weight loss. In total, there will be 16 treatment conditions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adults (ages 18+ years)
body mass index (BMI) 25.0 to 45.0 kg/m²
cellphone ownership with a texting plan
daily access to a personal scale
Disqualifiers
concurrent enrollment in another weight management intervention
loss of ≥5% body weight in the past 6 months
current use of a weight loss or anti-obesity medication
prior or planned bariatric surgery in the next 3 months
Trial design
Design model
Factorial
Treatments tested in this trial
Core Behavioral Weight Loss Intervention
BehavioralAll participants receive a 12-week core behavioral weight loss intervention consisting of the following: daily self-monitoring of weight; weekly behavioral lessons and action plans to promote healthy eating and physical activity; and tailored feedback. The intervention will be delivered remotely via email and/or text message.
Limit Red Zone Foods
BehavioralParticipants randomized to receive this component are given a goal to limit their Red Zone Foods (i.e., foods high in calories and low in nutrition) and are instructed to self-monitor them daily.
Limit Eating Window
BehavioralParticipants randomized to receive this component are given a goal to limit their eating windows (i.e., follow time-restricted eating) and are instructed to self-monitor them daily.
Increase Protein
BehavioralParticipants randomized to receive this component are given a goal to increase their protein intake and are instructed to self-monitor it daily.
Increase Fiber Intake
BehavioralParticipants randomized to receive this component are given a goal to increase their fiber intake and are instructed to self-monitor it daily.
Treatment groups
208 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Group A: Condition 1Experimental treatment 1 intervention
Group B: Condition 2Experimental treatment 2 interventions
Group C: Condition 3Experimental treatment 2 interventions
Group D: Condition 4Experimental treatment 3 interventions
Group E: Condition 5Experimental treatment 2 interventions
Group F: Condition 6Experimental treatment 3 interventions
Group G: Condition 7Experimental treatment 3 interventions
Group H: Condition 8Experimental treatment 4 interventions
Group I: Condition 9Experimental treatment 2 interventions
Group J: Condition 10Experimental treatment 3 interventions
Group K: Condition 11Experimental treatment 3 interventions
Group L: Condition 12Experimental treatment 4 interventions
Group M: Condition 13Experimental treatment 3 interventions
Group N: Condition 14Experimental treatment 4 interventions
Group O: Condition 15Experimental treatment 4 interventions
Group P: Condition 16Experimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Weight Change from Baseline to 3 Months
mean change in kg; assessed via participants' personal scales
Time frame
Baseline and 3 MonthsSecondary outcomes
1
Weight Change from Baseline to 1 Month
mean change in kg; assessed via participants' personal scales
Time frame
Baseline and 1 Month2
Clinically Significant Weight Loss at 3 Months
operationalized as the proportion of participants achieving ≥5% weight loss from baseline
Time frame
3 Months3
Moderate-to-Vigorous Physical Activity (MVPA) Change from Baseline to 3 Months
mean change; assessed via the Godin Leisure-Time Exercise Questionnaire (GLTEQ)'s MVPA Score Index. The GLTEQ is a self-report measure that assesses a typical week's frequency of engaging in different types of exercise (strenuous, moderate, mild/light) for at least 15 minutes. Minimum score is 0. Higher scores indicate more frequent exercise. Scores ≥ 24 indicate "active" while scores \< 24 indicate "insufficiently active."
Time frame
Baseline and 3 Months4
Caloric Intake Change from Baseline to 3 Months
mean change in kilocalories; assessed via the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24): 2 separate 24-hour diet recalls per time point: 1 week day, 1 weekend day
Time frame
Baseline and 3 MonthsOther outcomes
1
Engagement in Self-Monitoring Weight
operationalized as average percentage of days in the 12-week intervention with self-monitoring of weight; assessed via scale (then logged via text message or daily e-checklist); will report median (IQR) if non-normally distributed
Time frame
Weeks 1 to 122
Engagement in Self-Monitoring Eating Behaviors
operationalized as average percentage of days in the 12-week intervention with self-monitoring of eating behaviors; assessed via daily e-checklist; will report median (IQR) if non-normally distributed
Time frame
Weeks 1 to 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
Stanford Nutrition and Obesity Research Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: