TRE With Physical Activity for Weight Management

NCT04978376 | Completed Results

• 1 other identifier: 2021-0575
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 24 million older adults have prediabetes. Obesity, age related decreases in lean mass and increases in fat mass, and sedentary lifestyle have been associated with functional and cognitive decline in older adults. Innovative lifestyle strategies to treat obesity and pre-diabetes are critically needed. The proposed research will demonstrate that time restricted eating combined with resistance training is an effective non-pharmacological therapy to help obese prediabetic individuals reduce body fat, maintain lean mass, prevent progression of prediabetes to diabetes, and improve cognition.

Conditions

Pre Diabetes; Overweight and Obesity

Keywords

Intermittent Fasting

Outcome Measures

Primary Outcomes (1)

• Body Weight Changes Between Week 1 to Week 10

  Body weight assessed to the nearest 0.25 kg every week without shoes and in light clothing using a balance beam scale (HealthOMeter, Boca Raton, FL).

  Change from week 1 to week 10

Secondary Outcomes (3)

• Body Composition Changes From Week 1 to Week 10

  Change from week 1 to week 10

• Change in Insulin From Week 1 to Week 10

  Change from week 1 to week 10

• Glucose

  Change from week 1 to week 10

Study Arms (4)

Time restricted eating

EXPERIMENTAL

ad-libitum eating between 12:00-20:00

Behavioral: Time restricted eating

TRE with endurance training

EXPERIMENTAL

ad-libitum eating between 12:00-20:00 with 3-5 days of supervised endurance exercise per week

Behavioral: Time restricted eating

TRE with resistance training

EXPERIMENTAL

ad-libitum eating between 12:00-20:00 with 3-5 days of supervised resistance training per week

Behavioral: Time restricted eating

Control

NO INTERVENTION

no change in diet or physical activity

Interventions

Time restricted eating BEHAVIORAL

We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.

Also known as: resistance training, endurance exercise

TRE with endurance training; TRE with resistance training; Time restricted eating

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50 to 70 years old
• BMI between 25 and 50 kg/m2
• Pre-diabetic or insulin resistant (fasting glucose: 100-125 mg/dl, HBA1c 5.7%-6.4%, or HOMA-IR \>2.5)
• Sedentary or lightly active 24
• Are post menopausal (absence of menstrual cycle for 1 year)

You may not qualify if:

• Diabetic (fasting glucose: \>126 mg/dl or HBA1c \>6.5%)
• Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)
• Have uncontrolled hypertension, any other cardiovascular disease, or history of aneurysm
• History of alcohol dependance (score \>20 from Alcohol and Health Questionnaire)25
• Are not weight stable for 3 months prior to the beginning of study (weight gain or loss \> 4 kg)
• Are not able to keep a food diary or activity log for 7 consecutive days during screening
• Are taking drugs that influence study outcomes (weight loss, glucose-lowering medications)
• Are premenopausal, perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
• Mobility disability (unable to exercise for 40-60 minutes 3-5 days/week)
• Diagnosed comorbidities including systemic diseases (Parkinson's cirrhosis, renal disease or systemic rheumatic conditions), cancer, or cognitive impairment
• Are night shift workers
• Are smokers

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Overweight; Obesity; Intermittent Fasting

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Kelsey Gabel
• Organization: University of Illinois Chicago

kdipma2@uic.edu

312-413-8911

Study Officials

• Kelsey Gabel, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor and Postdoc

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: July 27, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 18, 2024
• Results First Posted: November 18, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)