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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 baseline, after 12 week weight loss intervention and 1 year after the end of second study condition
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 ~baseline, after 12 week weight loss intervention and 1 year after the end of second study condition
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 12 week weight loss intervention and 1 year after the end of second study condition 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
1,749 Previous Clinical Trials
2,163,985 Total Patients Enrolled
102 Trials studying Obesity
214,139 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
~12 spots leftby May 2025
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