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Behavioural Intervention

Digital Weight Loss Programs for Obesity

N/A
Recruiting
Led By Caitlin Martinez, MS, RD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week, 4 weeks, 3 months
Awards & highlights

Study Summary

This trial tests different digital weight loss approaches with or without human support to assess feasibility, acceptability & outcomes. All get 3-mo mHealth program & varying human support.

Who is the study for?
This trial is for adults aged 18-65 with a BMI of 27.5-45, who can read and speak English, own an iPhone with data and text plans, live in North Carolina, and are willing to attend up to five counseling sessions. Excluded are those with significant recent weight loss or surgery, certain medical conditions or treatments that affect exercise or weight control, psychiatric disorders within the last year, substance abuse issues, current pregnancy or immediate plans for it.Check my eligibility
What is being tested?
The study explores digital behavioral approaches to weight loss using a mobile health program over three months. Participants will be randomly assigned different levels of human support during the program to see which combination is most effective at helping people lose weight.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions rather than medication, side effects may include typical experiences associated with diet changes and increased physical activity such as muscle soreness or fatigue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week, 4 weeks, 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week, 4 weeks, 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility- Percentage of participants with missing data at 4 weeks
Feasibility- Rate of early nonresponse
Secondary outcome measures
Acceptability- Attrition
Acceptability- Overall program satisfaction rating
Acceptability- Rate of attendance at human support sessions
+11 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Human-Enhanced Kick-Off + App + CounselingExperimental Treatment3 Interventions
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.
Group II: Human-Enhanced Kick-Off + App + Check-InExperimental Treatment3 Interventions
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.
Group III: Human-Enhanced Kick-Off + AppExperimental Treatment2 Interventions
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.
Group IV: Fully Automated Kick-Off + App + CounselingExperimental Treatment3 Interventions
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.
Group V: Fully Automated Kick-Off + App + Check-InExperimental Treatment3 Interventions
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.
Group VI: Fully Automated Kick-Off + AppExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
App
2018
Completed Phase 4
~370
Counseling
2017
Completed Phase 4
~1970

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,563 Total Patients Enrolled
64 Trials studying Obesity
57,955 Patients Enrolled for Obesity
Academy of Nutrition and DieteticsOTHER
24 Previous Clinical Trials
5,466 Total Patients Enrolled
5 Trials studying Obesity
306 Patients Enrolled for Obesity
Caitlin Martinez, MS, RDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Media Library

PATH to Health (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05929469 — N/A
Obesity Research Study Groups: Human-Enhanced Kick-Off + App, Fully Automated Kick-Off + App + Counseling, Human-Enhanced Kick-Off + App + Check-In, Fully Automated Kick-Off + App, Fully Automated Kick-Off + App + Check-In, Human-Enhanced Kick-Off + App + Counseling
Obesity Clinical Trial 2023: PATH to Health Highlights & Side Effects. Trial Name: NCT05929469 — N/A
PATH to Health (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05929469 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria to participate in this clinical investigation?

"In order to be accepted into this medical trial, applicants must meet the age criteria (18-65) and have a Body Mass Index that classifies them as obese. A total of 99 participants are being admitted."

Answered by AI

What is the end-objective of this medical research?

"This 4-week investigation aims to analyse the amount of missing data collected. Secondary objectives include evaluating fluctuations in bodyweight measured by scales at home, and calculating attendance rates for human support sessions."

Answered by AI

Are there opportunities for recruitment in this clinical trial at the present?

"It appears that the medical trial in question, which was first posted on July 10th 2023 and last updated on June 26th 2023, is no longer recruiting patients. Nonetheless, clinicaltrials.gov advertises over 1250 other studies presently seeking participants."

Answered by AI

Is this clinical trial accessible to adults aged eighteen and older?

"This medical research seeks to include individuals aged 18 and above, yet below the age of 65."

Answered by AI

Who else is applying?

What site did they apply to?
University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches
2023. "PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05929469.
~66 spots leftby Apr 2025
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