Reset: Enhancing Weight Loss in a Digital Intervention

NCT07032571 | Not Yet Recruiting

• 1 other identifier: 81144
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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

Health Behavior; Obesity; Overweight; Weight Loss; Lifestyle Intervention

Keywords

obesity; overweight; weight loss; weight; health behavior; lifestyle intervention; lifestyle modification; multiphase optimization strategy; intervention; behavior change; weight reduction; lose weight; adults; BMI reduction; body fat reduction; weight control; weight change; weight management; obesity management; obesity treatment; digital health; digital intervention; remote intervention; standalone intervention; obesity prevention; diabetes prevention; mobile health; factorial design; intervention optimization

Outcome Measures

Primary Outcomes (1)

• Weight Change from Baseline to 3 Months

  mean change in kg; assessed via participants' personal scales

  Baseline and 3 Months

Secondary Outcomes (4)

• Weight Change from Baseline to 1 Month

  Baseline and 1 Month

• Clinically Significant Weight Loss at 3 Months

  3 Months

• Moderate-to-Vigorous Physical Activity (MVPA) Change from Baseline to 3 Months

  Baseline and 3 Months

• Caloric Intake Change from Baseline to 3 Months

  Baseline and 3 Months

Other Outcomes (2)

• Engagement in Self-Monitoring Weight

  Weeks 1 to 12

• Engagement in Self-Monitoring Eating Behaviors

  Weeks 1 to 12

Study Arms (16)

Condition 1

EXPERIMENTAL

Core Only

Behavioral: Core Behavioral Weight Loss Intervention

Condition 2

EXPERIMENTAL

Core + Increase Fiber

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Increase Fiber Intake

Condition 3

EXPERIMENTAL

Core + Increase Protein

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Increase Protein

Condition 4

EXPERIMENTAL

Core + Increase Protein + Increase Fiber

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Increase Protein; Behavioral: Increase Fiber Intake

Condition 5

EXPERIMENTAL

Core + Limit Eating Window

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Eating Window

Condition 6

EXPERIMENTAL

Core + Limit Eating Window + Increase Fiber

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Eating Window; Behavioral: Increase Fiber Intake

Condition 7

EXPERIMENTAL

Core + Limit Eating Window + Increase Protein

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Eating Window; Behavioral: Increase Protein

Condition 8

EXPERIMENTAL

Core + Limit Eating Window + Increase Protein + Increase Fiber

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Eating Window; Behavioral: Increase Protein; Behavioral: Increase Fiber Intake

Condition 9

EXPERIMENTAL

Core + Limit Red Zone Foods

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods

Condition 10

EXPERIMENTAL

Core + Limit Red Zone Foods + Increase Fiber

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Increase Fiber Intake

Condition 11

EXPERIMENTAL

Core + Limit Red Zone Foods + Increase Protein

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Increase Protein

Condition 12

EXPERIMENTAL

Core + Limit Red Zone Foods + Increase Protein + Increase Fiber

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Increase Protein; Behavioral: Increase Fiber Intake

Condition 13

EXPERIMENTAL

Core + Limit Red Zone Foods + Limit Eating Window

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Limit Eating Window

Condition 14

EXPERIMENTAL

Core + Limit Red Zone Foods + Limit Eating Window + Increase Fiber

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Limit Eating Window; Behavioral: Increase Fiber Intake

Condition 15

EXPERIMENTAL

Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Limit Eating Window; Behavioral: Increase Protein

Condition 16

EXPERIMENTAL

Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein + Increase Fiber

Behavioral: Core Behavioral Weight Loss Intervention; Behavioral: Limit Red Zone Foods; Behavioral: Limit Eating Window; Behavioral: Increase Protein; Behavioral: Increase Fiber Intake

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.

Condition 1; Condition 10; Condition 11; Condition 12; Condition 13; Condition 14; Condition 15; Condition 16; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8; Condition 9

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.

Condition 10; Condition 11; Condition 12; Condition 13; Condition 14; Condition 15; Condition 16; Condition 9

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.

Condition 13; Condition 14; Condition 15; Condition 16; Condition 5; Condition 6; Condition 7; Condition 8

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.

Condition 11; Condition 12; Condition 15; Condition 16; Condition 3; Condition 4; Condition 7; Condition 8

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.

Condition 10; Condition 12; Condition 14; Condition 16; Condition 2; Condition 4; Condition 6; Condition 8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (ages 18+ years)
• body mass index (BMI) 25.0 to 45.0 kg/m\^2
• cellphone ownership with a texting plan
• daily access to a personal scale
• daily access to a personal email account
• English language proficiency
• interest in losing weight through behavioral strategies
• living in the United States

You may not qualify if:

• 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
• current pregnancy, planned pregnancy in the next 3 months, or recent pregnancy in the past 6 months
• current breastfeeding or lactating
• living 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
• if weight loss is contraindicated or might be impacted by a condition (e.g., end stage renal disease, cancer, schizophrenia, dementia) or medication (e.g., steroids, antipsychotics)
• 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)
• participation in another weight loss study conducted in Dr. Patel's lab in the past 6 months
• investigator discretion for safety reasons

Sponsors & Collaborators

• Stanford University: lead
• Stanford Nutrition and Obesity Research Center: collaborator

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Health Behavior; Body Weight; Body Weight Changes

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Michele L Patel, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele L Patel, PhD

CONTACT

650-549-7047; ResetStudy@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be analyzed in a blinded fashion such that treatment allocation is not revealed.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study uses a full factorial experimental design to test the impact of four intervention components, each with two levels, on vs. off (i.e., a 2x2x2x2, or 2\^4 factorial design).

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 24, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The shared dataset will be made publicly available upon publication of the primary outcomes in a peer-reviewed journal.
• Access Criteria: Publicly available.

Locations

US (1)