NCT02047721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2019

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

5.4 years

First QC Date

January 15, 2014

Last Update Submit

October 20, 2020

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • fMRI Response to Visual Food Cues

    The neuronal response will be assessed by functional magnetic resonance imaging (fMRI) in response to visual food cues Blood oxygen dependent signal (BOLD) response in exposure to visual food cues will be measured during a fMRI scan and the difference between responses in those who lose weight vs. those who do not lose weight will be compared.

    12 weeks

Study Arms (2)

Physical Intervention

EXPERIMENTAL

A supervised exercise program

Behavioral: Exercise

Nutritional Intervention

EXPERIMENTAL

A supervised diet program

Behavioral: Diet

Interventions

ExerciseBEHAVIORAL

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.

Physical Intervention
DietBEHAVIORAL

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

Nutritional Intervention

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Kristina Legget, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 28, 2014

Study Start

February 1, 2014

Primary Completion

June 19, 2019

Study Completion

June 19, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)