NCT02152501

Brief Summary

The purpose of this study is to research the effects of exercise on calories eaten and expended. The investigator expects to find out whether subjects change their eating and activity behaviors when starting an exercise program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
1.8 years until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

May 22, 2014

Last Update Submit

April 8, 2025

Conditions

OverweightObese

Keywords

obeseoverweightexerciseenergy expenditure differencesrelative reinforcing values (RRV)foodphysical activitybiologicalneurobehavioralbehavioral

Outcome Measures

Primary Outcomes (1)

  • Negative Energy Balance as assessed by changes in adipose tissue

    Whether participants were able to maintain a negative energy balance will be assessed by pre-post changes in stored adipose tissue, as assessed by a dual-energy x-ray absorptiometry scan (DEXA).

    End Training (weeks 10-12)

Secondary Outcomes (9)

  • Change in relative reinforcing value (RRV) of food

    Pre-intervention (week 0) and End Training (weeks 10-12)

  • Average daily calories consumed as assessed by dietary recall

    Pre-intervention (week 0) and End Training (weeks 10-12)

  • Pre-post intervention changes in Ghrelin plasma levels

    Pre-intervention (week 0) and End Training (weeks 10-12)

  • Pre-post intervention changes in glucagon-like peptide 1 (GLP-1) plasma levels

    Pre-intervention (week 0) and End Training (weeks 10-12)

  • Pre-post intervention changes in Ghrelin concentrations

    Pre-intervention (week 0) and End Training (weeks 10-12)

  • +4 more secondary outcomes

Study Arms (2)

Exercise Energy Expenditure 300 kcal/day

EXPERIMENTAL

Subjects will be randomly assigned to this group and will exercise energy expenditure of 300 kcal/day.

Other: Exercise Energy Expenditure 300 kcal/day

Exercise Energy Expenditure 600 kcal/day

EXPERIMENTAL

Subjects will be randomly assigned to this group and will exercise energy expenditure of 600 kcal/day.

Other: Exercise Energy Expenditure 600 kcal/day

Interventions

Exercise Energy Expenditure 300 kcal/dayOTHER
Exercise Energy Expenditure 300 kcal/day
Exercise Energy Expenditure 600 kcal/dayOTHER
Exercise Energy Expenditure 600 kcal/day

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 40 years old
  • BMI of 25.0 - 35 kg/m2
  • willing to consent to study conditions
  • not taking medications that affects energy expenditure or eating
  • not using tobacco or nicotine products
  • no food allergies or limitations to eating certain food that would prohibit them from eating the study foods
  • not be dieting to lose weight
  • no major health problems
  • cannot have known cardiovascular, pulmonary or metabolic disease
  • cannot be regularly exercising in an aerobic manner more than twice per week
  • must have a liking of at least 5 out of 10 for 75% of the study foods

You may not qualify if:

  • \< 18 or \> 40 years old
  • BMI \< 25 or \>35 kg/m2
  • currently pregnant or trying to become pregnant, or lactating
  • currently using tobacco or nicotine
  • taking medication that affects energy expenditure or eating
  • food allergies to foods used in the study
  • regularly exercising in an aerobic manner more than twice per week
  • major health problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Grand Forks Human Nutrition Reserach Center

Grand Forks, North Dakota, 58203, United States

Location

MeSH Terms

Conditions

OverweightObesityMotor ActivityBehavior

Condition Hierarchy (Ancestors)

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

Study Officials

  • James Roemmich, PhD

    USDA GFHNRC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2014

First Posted

June 2, 2014

Study Start

April 1, 2016

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)