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Not Yet RecruitingNCT07032571

Reset: Enhancing Weight Loss in a Digital Intervention

Enhancing Weight Loss in a Digital Intervention Among Adults With Overweight or Obesity

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
208 (estimated)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCore Behavioral Weight Loss InterventionAll 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.
BEHAVIORALLimit Red Zone FoodsParticipants 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.
BEHAVIORALLimit Eating WindowParticipants 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.
BEHAVIORALIncrease ProteinParticipants randomized to receive this component are given a goal to increase their protein intake and are instructed to self-monitor it daily.
BEHAVIORALIncrease Fiber IntakeParticipants randomized to receive this component are given a goal to increase their fiber intake and are instructed to self-monitor it daily.

Timeline

Start date
2026-04-01
Primary completion
2026-08-01
Completion
2026-08-01
First posted
2025-06-24
Last updated
2026-03-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07032571. Inclusion in this directory is not an endorsement.