The Effects of Exercise on Appetite Regulation in Overweight/Obese Individuals

NCT ID: NCT02047721

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2019-06-19

Brief Summary

In this study the Investigators are examining the effects of a 12-week exercise program (intervention) on measures of appetite and food intake regulation in overweight to mildly obese healthy adults. The Investigators hypothesize that individuals who lose a significant amount of weight in response to the intervention will show a reduction in the brain response to food cues as measured by functional magnetic resonance imaging (fMRI) when compared to those who do not lose weight. These changes in neuronal activity will be associated to physiologic and behavioral measures.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Physical Intervention

A supervised exercise program

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

The intervention gradually increases EE from 150-200 kcal/day 5 days per week to a target of 400 kcal/d 5 days per week and will last a total of 12 weeks.

Nutritional Intervention

A supervised diet program

Group Type: EXPERIMENTAL

Diet

Intervention Type: BEHAVIORAL

A supervised diet program which has been successfully implemented by our group with a goal being to reduce energy intake by \~2000 kcal/week.

Interventions

Exercise

The intervention gradually increases EE from 150-200 kcal/day 5 days per week to a target of 400 kcal/d 5 days per week and will last a total of 12 weeks.

Intervention Type: BEHAVIORAL

Diet

A supervised diet program which has been successfully implemented by our group with a goal being to reduce energy intake by \~2000 kcal/week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• all ethnic groups and both genders;
• age: 21-45 yrs;
• BMI: 27-35;
• weight stable within +/- 5 percent in the last 6 months;
• sedentary (less than 1 hour of planned physical activity by self-report).

Exclusion Criteria

• history of cardiovascular disease (CVD), diabetes mellitus, uncontrolled hypertension, untreated thyroid disease, renal disease, hepatic disease, or any other medical condition affecting weight or energy metabolism;
• unable to effectively exercise due to cardiac, pulmonary, neurologic or orthopedic reasons;
• unable to pass screening graded exercise treadmill test;
• currently smoking;
• medications affecting weight, Energy Intake (EI) or Energy Expenditure (EE) in the last 6 months;
• weight loss or weight gain of >5 percent in past 6 months;
• currently pregnant, lactating or less than 6 months post-partum;
• bariatric surgery;
• major psychiatric disorder, presence of alcohol or substance abuse, current depression by history and/or a score >21 on the he Center for Epidemiologic Studies Depression Scale (CES-D), history of eating disorders and/or a score of >20 on the EATS-26;
• contraindication to MRI

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristina Legget, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Univeristy of Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-3252

Identifier Type: -

Identifier Source: org_study_id