PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches

Summary

The purpose of this initial pilot and feasibility study is to test different digital, behavioral weight loss approaches, with or without human support, using a sequential, multiple assignment, randomized trial (SMART) design. All participants in this pilot trial will receive a 3-month mobile health (mHealth) program. The dose of human support will vary by first- and second-line randomizations. The feasibility, acceptability, and preliminary outcomes for each of the treatment sequences will be assessed.

Conditions

• Overweight
• Obesity
• Overweight and Obesity

Interventions

BEHAVIORAL

App

Participants will receive an mHealth program.

BEHAVIORAL

Fully Automated Kick-Off

As an orientation to the study, participants will receive a fully automated kick-off session.

BEHAVIORAL

Human-Enhanced Kick-Off

As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.

BEHAVIORAL

Check-In

Participants will receive a check-in with a study interventionist.

BEHAVIORAL

Counseling

Participants will receive counseling from a study interventionist.

Sponsors & Collaborators

• Academy of Nutrition and Dietetics

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Caitlin Martinez, MS, RD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-02

Primary Completion

2024-04-25

Completion

2024-04-25

Countries

• United States

Study Locations