PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches
1 other identifier
interventional
99
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedStudy Start
First participant enrolled
October 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2024
CompletedMay 30, 2024
October 1, 2023
7 months
June 13, 2023
May 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility- Rate of early nonresponse
The rate of early response will be calculated as the number of individuals deemed "early responders" divided by the total number of participants randomized.
4 weeks
Feasibility- Percentage of participants with missing data at 4 weeks
The percentage of participants with missing data at 4 weeks will be calculated as the number of participants who do not complete the 4-week weight assessment divided by the total number of participants randomized.
4 weeks
Secondary Outcomes (14)
Weight Change- Percent weight change from baseline to 3 months
Baseline, 3 months
Weight Change- Percent weight change from baseline to 4 weeks
Baseline, 4 weeks
Weight Change- Percent weight change from 4 weeks to 3 months
4 weeks, 3 months
Acceptability- Rate of attendance at human support sessions
Up to 3 months
Acceptability- Attrition
Up to 3 months
- +9 more secondary outcomes
Study Arms (6)
Fully Automated Kick-Off + App
EXPERIMENTALThis arm includes participants who respond to the Fully Automated Kick-Off + App in stage 1. In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program. In stage 2, responders to the Fully Automated Kick-Off + App will continue with the mHealth program, alone, for the remainder of the study.
Human-Enhanced Kick-Off + App
EXPERIMENTALThis arm includes participants who respond to the Human-Enhanced Kick-Off + App in stage 1. In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program. In stage 2, responders to the Human-Enhanced Kick-Off + App will continue with the mHealth program, alone, for the remainder of the study.
Fully Automated Kick-Off + App + Check-In
EXPERIMENTALThis arm includes participants who do not respond to the Fully Automated Kick-Off + App in stage 1. In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program. In stage 2, they will continue with the mHealth program, but will also receive a check-in with a study interventionist.
Fully Automated Kick-Off + App + Counseling
EXPERIMENTALThis arm includes participants who do not respond to the Fully Automated Kick-Off + App in stage 1. In stage 1, participants will receive a Fully Automated Kick-Off and an mHealth program. In stage 2, they will continue with the standard mHealth program, but will also receive counseling from a study interventionist.
Human-Enhanced Kick-Off + App + Check-In
EXPERIMENTALThis arm includes participants who do not respond to the Human-Enhanced Kick-Off + App in stage 1. In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program. In stage 2, they will continue with the mHealth program, but will also receive a check-in with a study interventionist.
Human-Enhanced Kick-Off + App + Counseling
EXPERIMENTALThis arm includes participants who do not respond to the Human-Enhanced Kick-Off + App in stage 1. In stage 1, the participant's kick-off will include a session with a study interventionist. They will also receive an mHealth program. In stage 2, they will continue with the standard mHealth program, but will also receive counseling from a study interventionist.
Interventions
Participants will receive an mHealth program.
As an orientation to the study, participants will receive a fully automated kick-off session.
As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.
Participants will receive a check-in with a study interventionist.
Participants will receive counseling from a study interventionist.
Eligibility Criteria
You may qualify if:
- Current age: 18-65 years
- Lives in North Carolina
- Body mass index (BMI) of 27.5-45 kg/m\^2
- Ability to read, write, and speak English
- Ownership of iPhone with a data and texting plan
- Ability to commit to the required counseling sessions (0-5 sessions, based on randomization)
- Is not living a participant or staff member on this trial
- Willingness to be randomized to any of the treatment sequences
You may not qualify if:
- Weight loss of more than 10 pounds in the last 6 months that was maintained
- A history of weight loss surgery
- Pre-existing medical condition(s) that prevent them from adhering to a supervised exercise routine
- Have Type 1 Diabetes or are currently taking medicine for Type 2 Diabetes
- Have recently been diagnosed or treated for cancer
- Currently pregnant, pregnant within the past 6 months, or plan to become pregnant in the next 6 months
- Report taking prescription or over the counter medication with a known impact on metabolism or weight
- Report a history of an eating disorder
- History of psychotic disorder or bipolar disorder, or have been hospitalized for depression or other psychiatric disorder within the past 12 months
- History of alcohol or substance abuse
- Current participation in another weight loss program that may interfere with participation in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Related Publications (1)
Martinez CE, Nezami BT, Mayer-Davis E, Willis EA, Gorin AA, Tate DF. Results of a pilot sequential multiple assignment randomized trial using counseling to augment a digital weight loss program. Obes Sci Pract. 2024 Nov 7;10(6):e70018. doi: 10.1002/osp4.70018. eCollection 2024 Dec.
PMID: 39512729DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caitlin Martinez, MS, RD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2023
First Posted
July 3, 2023
Study Start
October 2, 2023
Primary Completion
April 25, 2024
Study Completion
April 25, 2024
Last Updated
May 30, 2024
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share