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Diet and Exercise Responses in Obesity (ARrOW Trial)

N/A
Recruiting
Led By Daniel Bessesen, MD
Research Sponsored by University of Colorado, Denver
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 30 minutes at baseline and 1 year following second diet condition; reduced group will have an additional measurement at week 12 following weight loss period.
Awards & highlights

ARrOW Trial Summary

This trial will help to understand why some obese people struggle to keep weight off after dieting, by studying their appetite, energy expenditure, and fat metabolism.

Who is the study for?
This trial is for adults with obesity (BMI of 30-38) who are either content with their weight or want to lose weight, do minimal exercise, and have a stable sleep schedule. They must live near CU-AMC, own a smartphone, and women must use contraception if needed. People can't join if they've had weight loss surgery, abnormal diets, certain diseases including HIV/hepatitis B/C or psychiatric conditions, work night shifts or take medications affecting weight.Check my eligibility
What is being tested?
The study looks at how obese individuals respond biologically after losing weight through diet alone or diet plus exercise. It examines appetite control, energy usage during rest and activity levels following brief periods of overeating to understand factors that may prevent or contribute to regaining lost weight.See study design
What are the potential side effects?
Since the interventions include lifestyle changes like overfeeding and exercise training rather than medication, side effects might include discomfort from excess eating or muscle soreness from new physical activities.

ARrOW Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes at baseline and 1 year following second diet condition; reduced group will have an additional measurement at week 12 following weight loss period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes at baseline and 1 year following second diet condition; reduced group will have an additional measurement at week 12 following weight loss period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fat oxidation as a correlate of weight regain as measured by room calorimetry
Secondary outcome measures
24h hormone and metabolite profiles as a correlate of weight regain as measured by assay of plasma samples
Body Composition via DXA
Body weight per scale
+13 more
Other outcome measures
Change in fitness as measured by indirect calorimetry

ARrOW Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Reduced obese + diet + exerciseExperimental Treatment3 Interventions
Persons with obesity randomized to a weight loss program consisting of caloric restriction, behavioral support, and supervised endurance exercise training. Following weight loss persons in this group will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes.
Group II: ControlActive Control1 Intervention
Persons with obesity who do not undergo weight loss will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes.
Group III: Reduced obese + diet groupActive Control2 Interventions
Persons with obesity randomized to a weight loss program consisting of caloric restriction and behavioral support. Following weight loss persons in this group will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,508 Total Patients Enrolled
100 Trials studying Obesity
213,634 Patients Enrolled for Obesity
University of Colorado, BoulderOTHER
119 Previous Clinical Trials
29,119 Total Patients Enrolled
3 Trials studying Obesity
610 Patients Enrolled for Obesity
Daniel Bessesen, MDPrincipal InvestigatorUniversity of Colorado Anschutz Health and Wellness Center
3 Previous Clinical Trials
38 Total Patients Enrolled

Media Library

Weight Loss Clinical Trial Eligibility Overview. Trial Name: NCT03857048 — N/A
Obesity Research Study Groups: Reduced obese + diet + exercise, Control, Reduced obese + diet group
Obesity Clinical Trial 2023: Weight Loss Highlights & Side Effects. Trial Name: NCT03857048 — N/A
Weight Loss 2023 Treatment Timeline for Medical Study. Trial Name: NCT03857048 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT03857048 — N/A

Frequently Asked Questions

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

Is the enrollment period open for participants at this time?

"According to clinicaltrials.gov, the recruitment process for this trial has been ongoing since February 15th 2019 and was recently updated on March 17th 2022 - thus confirming that enrolment is still open."

Answered by AI

What is the cap for enrolment in this clinical trial?

"Yes, the specified trial is currently calling for volunteers. Initially listed on February 15th 2019 and recently updated on March 17th 2022, this research requires 75 individuals to take part in their single-site venture."

Answered by AI

What eligibility requirements must I fulfill to take part in this experimentation?

"This clinical trial is seeking 75 adults aged between 30 and 50 with obesity. In order to qualify, participants should possess a BMI of 30-38 kg/m2 and not have changed their weight significantly in the past six months. Additionally, they must report regular sleep patterns over the month leading up to screening, own a smartphone (Android or Apple iOS), be neither pregnant nor lactating within 6 months of enrolment, and reside no more than 45 minutes from CU-AMC (with exceptions)."

Answered by AI

Does this study recruit participants older than 45 years of age?

"The inclusion criteria for this experiment states that the age of participants must be between 30 to 50 years old."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
What site did they apply to?
University of Colorado Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've lost 50 lbs on Optavia but got tired of the limited menu and hard to maintain with my work schedule.
PatientReceived 1 prior treatment
Ive tried personal training, prescription weight loss drugs, diet change but nothing really works. I may lose 5-8lbs but then stop and gain it back despite continuing to try.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How often are the visits?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Adaptive Responses to Overfeeding and Weight
2019. "Adaptive Responses to Overfeeding and Weight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03857048.
~12 spots leftby Apr 2025
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