Exercise and Weight Control

NCT03413826 | Completed

• 1 other identifier: 17-0758-F2L
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this project is to determine the biological, neurobehavioral, and behavioral compensatory responses to exercise training-induced energy deficits in overweight to obese men and women. Participants will engage in exercise at either 2 days or 6 days per week for 12 weeks and have body composition assessed via DXA before and after the exercise intervention. Accumulated energy balance (weight loss converted to kcal) will be compared to exercise energy expenditure to determine each individual's level of compensation, termed compensation index. Predictors of compensation index that will be assessed will include hunger/satiety hormone concentrations at rest and in response to a meal, reward driven feeding, changes in metabolic rate, and energy intake throughout the intervention. Exercise reinforcement and physical activity will also be assessed as a separate aim to determine if exercise reinforcement can be increased and if this can promote greater habitual physical activity after the intervention has ceased.

Conditions

Obesity; Exercise Reinforcement

Keywords

weight loss; exercise; reinforcement; compensation

Outcome Measures

Primary Outcomes (1)

• Accumulated Energy Balance

  Change in energy balance assessed via DXA (weight loss)

  determined at 12 weeks by comparing to baseline data

Secondary Outcomes (7)

• Compensation index

  determined at 12 weeks by comparing to baseline data

• Hormonal responses to meal and fasting levles

  baseline to 12 weeks

• Changes in dietary intake

  baseline to 12 weeks

• Food reinforcment

  baseline to 12 weeks

• Exercise reinforcement

  baseline to 12 weeks, 12 weeks to 16 weeks, baseline to 16 weeks.

Study Arms (3)

6 Days per week

EXPERIMENTAL

This group will exercise 6 days per week and expend 3,000 kcal per week for 12 weeks

Behavioral: Exercise

2 Days per week

EXPERIMENTAL

This group will exercise 2 days per week and expend 3,000 kcal per week for 12 weeks

Behavioral: Exercise

control

NO INTERVENTION

This group will remain sedentary for 12 weeks

Interventions

Exercise BEHAVIORAL

The intervention groups will perform aerobic exercise for 12 weeks, expending 3,000 kcal of energy per week.

2 Days per week; 6 Days per week

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be overweight to obese (BMI 25-35 kg/m2) Not pregnant or lactating or planning to become pregnant in the next 6 months
• No limitations to safely participating in physical activity

You may not qualify if:

• Currently dieting to lose weight and no weight loss or gain \>2kg over the past 3 months,
• Taking any medications that affect energy expenditure or eating,
• Regularly exercising (planned and structured aerobic or resistance activity).
• Participants must have no major health problems, cannot have known cardiovascular (cardiac, peripheral vascular, cerebrovascular), pulmonary (COPD, interstitial lung disease, cystic fibrosis) or metabolic (diabetes, thyroid disorders, renal or liver disease) disease.
• Tobacco use
• Have a medical condition that prevents safe exercise.

Sponsors & Collaborators

• University of Kentucky: lead

Study Sites (1)

Funkhouser Building

Lexington, Kentucky, 40506, United States

Location

Related Publications (1)

• Flack KD, Hays HM, Moreland J. Incentive sensitization for exercise reinforcement to increase exercise behaviors. J Health Psychol. 2021 Nov;26(13):2487-2504. doi: 10.1177/1359105320914073. Epub 2020 Apr 27.

  PMID: 32338538 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kyle D Flack, PhD, RD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Baseline demographic and physical characteristics will be reported as means and standard errors. Baseline group (6 days/week, 2 days per week exercise, sedentary control) differences will be tested with one-way ANOVA. Alterations in accumulated negative energy balance, body composition, RRVfood, RRVexercise, dietary intake, energy expenditure, exercise discomfort, hunger/satiety hormones, and fitness will be tested with two-way repeated measures analysis of variance (RMANOVA) with group treated as a between-subjects variable and time treated as a within subjects variable.

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 29, 2018
• Study Start: January 4, 2018
• Primary Completion: August 18, 2019
• Study Completion: August 18, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

US (1)