Reset: Enhancing Weight Loss in a Digital Intervention

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07032571
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Core Behavioral Weight Loss Intervention — BEHAVIORAL
    All 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 — BEHAVIORAL
    Participants 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 — BEHAVIORAL
    Participants 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 — BEHAVIORAL
    Participants 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 — BEHAVIORAL
    Participants randomized to receive this component are given a goal to increase their fiber intake and are instructed to self-monitor it daily.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
208 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Condition 1
    Core Only
  • Experimental: Condition 2
    Core + Increase Fiber
  • Experimental: Condition 3
    Core + Increase Protein
  • Experimental: Condition 4
    Core + Increase Protein + Increase Fiber
  • Experimental: Condition 5
    Core + Limit Eating Window
  • Experimental: Condition 6
    Core + Limit Eating Window + Increase Fiber
  • Experimental: Condition 7
    Core + Limit Eating Window + Increase Protein
  • Experimental: Condition 8
    Core + Limit Eating Window + Increase Protein + Increase Fiber
  • Experimental: Condition 9
    Core + Limit Red Zone Foods
  • Experimental: Condition 10
    Core + Limit Red Zone Foods + Increase Fiber
  • Experimental: Condition 11
    Core + Limit Red Zone Foods + Increase Protein
  • Experimental: Condition 12
    Core + Limit Red Zone Foods + Increase Protein + Increase Fiber
  • Experimental: Condition 13
    Core + Limit Red Zone Foods + Limit Eating Window
  • Experimental: Condition 14
    Core + Limit Red Zone Foods + Limit Eating Window + Increase Fiber
  • Experimental: Condition 15
    Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein
  • Experimental: Condition 16
    Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein + Increase Fiber

Primary Outcome Measure

Weight Change from Baseline to 3 Months [ Time Frame: Baseline and 3 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicinePalo AltoCalifornia94304-

Find similar trials in Palo Alto, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Stanford University School of Medicine· Palo Alto, CA

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