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Digital Health Tool for Weight Loss (AGILE Trial)
N/A
Waitlist Available
Led By Deborah F. Tate, PhD
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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,3 months, 6 months
Awards & highlights
AGILE Trial Summary
This trial will test a new digital health tool, Just-in-Time Adaptive Interventions (JITAI), to see if it can help people lose weight more effectively than existing remotely delivered interventions.
Who is the study for?
This trial is for English-speaking adults with a BMI of 25-45 who own a smartphone and are willing to be randomly assigned to different digital weight loss interventions. They should exercise less than 210 minutes per week but can't have lost significant weight recently or have certain medical conditions like heart issues, recent psychiatric hospitalization, or active cancer.Check my eligibility
What is being tested?
The study tests various components of a Just-in-Time Adaptive Intervention (JITAI) for obesity. It aims to find the most effective combination of personalized feedback and adaptive goals using mobile technology to help participants lose weight comparably to in-person programs.See study design
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects may include typical responses to dieting and increased physical activity such as muscle soreness, fatigue, hunger pangs, or psychological stress from behavior change.
AGILE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline,3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline,3 months, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Achievement of 5% weight loss
Autonomy Support score
Competence for Diet and Physical Activity score
+10 moreAGILE Trial Design
32Treatment groups
Experimental Treatment
Group I: Condition 9Experimental Treatment6 Interventions
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + No Choice
Group II: Condition 8Experimental Treatment6 Interventions
Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Adaptive Content + Choice
Group III: Condition 7Experimental Treatment6 Interventions
Core+ Standard Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Group IV: Condition 6Experimental Treatment6 Interventions
Core + Standard Diet Monitoring + Daily Activity Goal + Adaptive Timing + Standard Content + Choice
Group V: Condition 5Experimental Treatment6 Interventions
Core+Standard Diet Monitoring+Daily Activity Goal+Adaptive Timing+Standard Content+No Choice
Group VI: Condition 4Experimental Treatment6 Interventions
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice
Group VII: Condition 32Experimental Treatment6 Interventions
Core + Simplified Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content+Choice
Group VIII: Condition 31Experimental Treatment6 Interventions
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Group IX: Condition 30Experimental Treatment6 Interventions
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ Choice
Group X: Condition 3Experimental Treatment6 Interventions
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + No Choice
Group XI: Condition 29Experimental Treatment6 Interventions
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Standard Content+ No Choice
Group XII: Condition 28Experimental Treatment6 Interventions
Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice
Group XIII: Condition 27Experimental Treatment6 Interventions
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice
Group XIV: Condition 26Experimental Treatment6 Interventions
Core + Simplified Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice
Group XV: Condition 25Experimental Treatment6 Interventions
Core+ Simplified Diet Monitoring+ Weekly Activity Goal+ Fixed Timing+ Standard Content+ No Choice
Group XVI: Condition 24Experimental Treatment6 Interventions
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ Choice
Group XVII: Condition 23Experimental Treatment6 Interventions
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Group XVIII: Condition 22Experimental Treatment6 Interventions
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ Choice
Group XIX: Condition 21Experimental Treatment6 Interventions
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Adaptive Timing+ Standard Content+ No Choice
Group XX: Condition 20Experimental Treatment6 Interventions
Core + Simplified Diet Monitoring + Daily Activity Goal + Fixed Timing + Adaptive Content + Choice
Group XXI: Condition 2Experimental Treatment6 Interventions
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + Choice
Group XXII: Condition 19Experimental Treatment6 Interventions
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Adaptive Content+ No Choice
Group XXIII: Condition 18Experimental Treatment6 Interventions
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ Choice
Group XXIV: Condition 17Experimental Treatment6 Interventions
Core+ Simplified Diet Monitoring+ Daily Activity Goal+ Fixed Timing+ Standard Content+ No Choice
Group XXV: Condition 16Experimental Treatment6 Interventions
Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Adaptive Content + Choice
Group XXVI: Condition 15Experimental Treatment6 Interventions
Core + Standard Diet Monitoring+ Weekly Activity Goal+ Adaptive Timing+ Adaptive Content+ No Choice
Group XXVII: Condition 14Experimental Treatment6 Interventions
Core + Standard Diet Monitoring + Weekly Activity Goal + Adaptive Timing + Standard Content + Choice
Group XXVIII: Condition 13Experimental Treatment6 Interventions
Core+Standard Diet Monitoring+Weekly Activity Goal+Adaptive Timing+Standard Content+No Choice
Group XXIX: Condition 12Experimental Treatment6 Interventions
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + Choice
Group XXX: Condition 11Experimental Treatment6 Interventions
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Adaptive Content + No Choice
Group XXXI: Condition 10Experimental Treatment6 Interventions
Core + Standard Diet Monitoring + Weekly Activity Goal + Fixed Timing + Standard Content + Choice
Group XXXII: Condition 1Experimental Treatment6 Interventions
Core + Standard Diet Monitoring + Daily Activity Goal + Fixed Timing + Standard Content + No Choice
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Core
2017
Completed Early Phase 1
~1180
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,217 Total Patients Enrolled
64 Trials studying Obesity
57,446 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,360 Previous Clinical Trials
4,314,244 Total Patients Enrolled
446 Trials studying Obesity
588,330 Patients Enrolled for Obesity
Deborah F. Tate, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
7 Previous Clinical Trials
1,171 Total Patients Enrolled
4 Trials studying Obesity
1,011 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Type 1 diabetes or am being treated for Type 2 diabetes.I have health issues that affect my walking or weight, including recent cancer treatment or tuberculosis.I have not been hospitalized for depression or any psychiatric disorder in the last year.I am willing to be assigned to any treatment group in the study.Your body mass index (BMI) falls between 25 and 45.You have had a previous diagnosis of a mental illness like schizophrenia or bipolar disorder.I am willing to be assigned to any treatment group in the study.You don't participate in at least 210 minutes per week of exercise that makes you breathe harder and your heart beat faster.Your body mass index (BMI) should be between 25 and 45 kg/m^2.I have lost and kept off 10 or more pounds in the last 6 months.You are not physically active and do not engage in at least 30 minutes of moderate-to-vigorous exercise per day for at least 7 days a week.I am currently on medication to lose weight.
Research Study Groups:
This trial has the following groups:- Group 1: Condition 14
- Group 2: Condition 13
- Group 3: Condition 22
- Group 4: Condition 16
- Group 5: Condition 4
- Group 6: Condition 11
- Group 7: Condition 18
- Group 8: Condition 10
- Group 9: Condition 17
- Group 10: Condition 8
- Group 11: Condition 20
- Group 12: Condition 7
- Group 13: Condition 21
- Group 14: Condition 32
- Group 15: Condition 6
- Group 16: Condition 19
- Group 17: Condition 31
- Group 18: Condition 5
- Group 19: Condition 9
- Group 20: Condition 12
- Group 21: Condition 15
- Group 22: Condition 30
- Group 23: Condition 1
- Group 24: Condition 2
- Group 25: Condition 3
- Group 26: Condition 23
- Group 27: Condition 24
- Group 28: Condition 25
- Group 29: Condition 26
- Group 30: Condition 27
- Group 31: Condition 28
- Group 32: Condition 29
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollment applications being accepted for this research project currently?
"According to the clinicaltrials.gov listing, this medical trial is currently enrolling patients. The post was created on April 28th 2022 and modified as recently as October 26th of that same year."
Answered by AI
What prerequisites must one satisfy to be granted entry into this research project?
"Qualified participants for this clinical trial must be between 18 to 35 years old, and currently suffer from obesity. The study is looking to recruit 608 people in total."
Answered by AI
Does the current research program accept participants aged 30 and over?
"The parameters for participants in this medical trial are limited to those between the ages of 18 and 35. For reference, there are 202 trials enrolling minors and 596 clinical studies seeking seniors as patients."
Answered by AI
How many participants are enrolling in this research endeavor?
"Yes, according to the information published by clinicaltrials.gov this medical trial is still open for recruitment and was originally posted on April 28th 2022 before being recently updated on October 26th 2022. 608 patients are needed at a single research centre."
Answered by AI
Who else is applying?
What state do they live in?
Kansas
North Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of North Carolina at Chapel Hill
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