PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches
NCT ID: NCT05929469
Last Updated: 2024-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2023-10-02
2024-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Human-Enhanced Kick-Off + App + Check-In
This 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.
App
Participants will receive an mHealth program.
Human-Enhanced Kick-Off
As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.
Check-In
Participants will receive a check-in with a study interventionist.
Fully Automated Kick-Off + App + Counseling
This 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.
App
Participants will receive an mHealth program.
Fully Automated Kick-Off
As an orientation to the study, participants will receive a fully automated kick-off session.
Counseling
Participants will receive counseling from a study interventionist.
Human-Enhanced Kick-Off + App
This 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.
App
Participants will receive an mHealth program.
Human-Enhanced Kick-Off
As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.
Fully Automated Kick-Off + App + Check-In
This 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.
App
Participants will receive an mHealth program.
Fully Automated Kick-Off
As an orientation to the study, participants will receive a fully automated kick-off session.
Check-In
Participants will receive a check-in with a study interventionist.
Fully Automated Kick-Off + App
This 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.
App
Participants will receive an mHealth program.
Fully Automated Kick-Off
As an orientation to the study, participants will receive a fully automated kick-off session.
Human-Enhanced Kick-Off + App + Counseling
This 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.
App
Participants will receive an mHealth program.
Human-Enhanced Kick-Off
As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.
Counseling
Participants will receive counseling from a study interventionist.
Interventions
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App
Participants will receive an mHealth program.
Fully Automated Kick-Off
As an orientation to the study, participants will receive a fully automated kick-off session.
Human-Enhanced Kick-Off
As an orientation to the study, participants will receive a kick-off session that includes time with a study interventionist.
Check-In
Participants will receive a check-in with a study interventionist.
Counseling
Participants will receive counseling from a study interventionist.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Academy of Nutrition and Dietetics
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Caitlin Martinez, MS, RD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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References
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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.
Other Identifiers
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23-0396
Identifier Type: -
Identifier Source: org_study_id
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