NCT03985787

Brief Summary

This study plans to learn more about how resistance training impacts appetite and the brain's response to food. The study will be evaluating how the brain responds to food images as well as how behaviors and hormones change with a 12 week resistance training intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2018

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

2.6 years

First QC Date

April 11, 2019

Last Update Submit

September 22, 2021

Conditions

Obesity

Keywords

Resistance ExerciseAppetite Regulation

Outcome Measures

Primary Outcomes (1)

  • Change in Neuronal Responses to Food Cues in Regions of Interest

    Changes in the insula, prefrontal cortex, and hypothalamus response to salient food cues (pre vs post-RT) as measured by fMRI in response to 12-weeks of RT

    Baseline, 12 Weeks

Secondary Outcomes (6)

  • Change in Whole Brain Response

    Baseline, 12 Weeks

  • Change in Default Mode Network

    Baseline, 12 Weeks

  • Changes in Appetite Ratings

    Baseline, 12 Weeks

  • Changes in Appetite-Related Hormones

    Baseline, 12 Weeks

  • Change in In Lab Ad Libitum Energy Intake (kcals)

    Baseline, 12 Weeks

  • +1 more secondary outcomes

Other Outcomes (26)

  • Changes in Free-Living Physical Activity and Sedentary Time

    Baseline, 12 Weeks

  • Changes in Muscular Strength

    Baseline, 12 Weeks

  • Change in Body Mass (kg)

    Baseline, 12 Weeks

  • +23 more other outcomes

Study Arms (1)

All Participants

EXPERIMENTAL

12-weeks of a full body resistance training intervention. Intervention will consist of 4 training sessions per week that are approximately 45-minutes in length. Two days will be upper body training and 2 days lower body

Behavioral: Resistance Training

Interventions

Resistance TrainingBEHAVIORAL

12-weeks of a full body resistance training intervention. Intervention will consist of 4 training sessions per week that are approximately 45-minutes in length. Two days will be upper body training and 2 days lower body

All Participants

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • all ethnic groups
  • both sexes
  • age: 18-55
  • BMI: 27-40 kg/m2
  • weight stable (±5% in last 6 months)
  • sedentary (\<2 hours of planned physical activity/week by self-report, no RT in previous 12-months)

You may not qualify if:

  • history of CVD
  • uncontrolled Hypertension
  • untreated thyroid disease
  • renal disease
  • hepatic disease
  • other condition affecting weight/metabolism
  • unable to exercise
  • smoker
  • medications affecting weight
  • EI or EE in past 6 months
  • weight loss/gain \>5% in past 6 months
  • post-menopausal women (defined as age appropriate women with 6 months or more of amenorrhea)
  • currently pregnant, lactating, \< 6 months post-partum
  • woman who have undergone oophorectomy
  • bariatric surgery
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marc-Andre Cornier, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 11, 2019

First Posted

June 14, 2019

Study Start

October 24, 2018

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)