Optimal Timing of Exercise Initiation Within a Lifestyle Weight Loss Program

NCT01985568 | Completed

• 2 other identifiers: 13-1550R01DK097266
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to evaluate the extent to which an exercise intervention timed after diet-induced weight loss (rather than initiated at the same time) improves exercise adherence and long-term weight loss. An 18 month randomized trial will be used to compare two behavioral weight loss programs; standard behavioral therapy (Standard BT) and sequential behavioral therapy (Sequential BT). The Standard BT group will receive a traditional behavioral weight loss program where diet and exercise changes are initiated at the same time. The Sequential BT group will receive a program that focuses solely on dietary changes in the initial 6 months, and then incorporates exercise in the ensuing 6 months. Both groups will be followed for 18 months to assess long-term weight loss. The hypothesis is that delivery of diet and exercise interventions in sequence will result in improved adherence to exercise and weight loss at 18 months when compared to a traditional program in which identical diet and exercise interventions are initiated at the same time. This study could identify a strategy that could aid in the development of more effective obesity treatment programs and help more people achieve and sustain a weight loss.

Conditions

Obesity

Keywords

Obesity; weight-loss; Physical activity

Outcome Measures

Primary Outcomes (2)

• Change in Body Weight

  Body weight will be assessed.

  Baseline, 3, 6, 9, 12, 15, and 18 months.

• Change in Body Composition

  Body composition will be assessed.

  Baseline, 6, 12, and 18 months.

Secondary Outcomes (6)

• Objectively Measured Change in Physical Activity

  Baseline, 6, 12, and 18 months.

• Change in Maximal Aerobic Capacity

  Baseline, 6, 12, and 18 months.

• Change in Diet Composition

  Baseline, 6, 12, and 18 months.

• Change in Engagement in Weight Control Eating Behaviors

  Baseline, 6, 12, and 18 months.

• Change in Dietary Weight Loss Program Attendance and Adherence

  18 months

Other Outcomes (12)

• Change in Number of Exercise Related Injuries and Adverse Events

  18 months

• Change in Mood

  Baseline, 6, 12, and 18 months.

• Change in Exercise Self-Efficacy

  Baseline, 6, 12, and 18 months.

Study Arms (2)

Standard Behavioral Therapy (Standard BT)

ACTIVE COMPARATOR

Standard BT: This group will follow a traditional model of initiating exercise concurrently with a dietary intervention for weight loss within an 18 month behavioral weight loss program.

Behavioral: Standard BT

Sequential Behavioral Therapy (Sequential BT)

EXPERIMENTAL

Sequential BT: This group will receive diet and exercise interventions delivered sequentially within an 18 month behavioral weight loss program.

Behavioral: Sequential BT

Interventions

Sequential BT BEHAVIORAL

Both study arms (Standard BT and Sequential BT) will receive an identical 6 month group-based weight loss program, followed by an identical 6 month group-based weight maintenance program, followed by an identical 6 months of weight maintenance phone support. Both groups will also receive an identical 6 month exercise intervention. Groups will differ only in the timing of exercise initiation. Sequential BT will be asked not to begin exercise during months 0-6. They will receive a progressive exercise program and exercise behavior support during months 7-12.

Sequential Behavioral Therapy (Sequential BT)

Standard BT BEHAVIORAL

Both study arms (Standard BT and Sequential BT) will receive an identical 6 month group-based weight loss program, followed by an identical 6 month group-based weight maintenance program, followed by an identical 6 months of weight maintenance phone support. Both groups will also receive an identical 6 month exercise intervention. Groups will differ only in the timing of exercise initiation. Standard BT will begin exercise immediately upon starting the 6 month dietary weight loss intervention. They will receive a progressive exercise program and exercise behavior support during months 0-6.

Standard Behavioral Therapy (Standard BT)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-55
• Body Mass Index 27-42 kilograms/meters squared
• Sedentary: defined as regular exercise of less than 100 minutes per week at moderate intensity or greater during the previous 6 months
• No self-report of acute or chronic disease (heart disease, diabetes, gastrointestinal disorders and orthopedic problems in particular)
• No plans to relocate or for extended travel (more than 1 week) within the next 18 months
• No current tobacco use

You may not qualify if:

• Live or work within 20 minutes of the University of Colorado Anschutz Health and Wellness Center to ensure reasonable ability to comply with requirement to attend group weight loss sessions and supervised exercise sessions. Exceptions can be made at the discretion of the Study Principal Investigator (PI) on a case by case basis for highly motivated subjects.
• For Females
• Not currently pregnant or lactating
• Not pregnant within the past 6 months
• Not planning to become pregnant in the next 18 months
• Sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception.
• Presence or history of health problems which would affect appetite, food intake, energy metabolism, or ability to optimally participate in the exercise component including: diabetes, cardiovascular disease, peripheral vascular disease, cerebrovascular disease, uncontrolled hypertension, uncontrolled hyper or hypothyroidism, cancer (within the last 5 years, except skin cancer), human immunodeficiency virus (HIV) infection, significant gastrointestinal, pulmonary, renal, musculoskeletal, neurologic, or hematologic disease
• Symptoms suggestive of cardiovascular disease: chest pain, shortness of breath at rest or with mild exertion, syncope
• Abnormal resting electrocardiogram (ECG): serious arrhythmias, including multifocal Premature Ventricular Contractions (PVCs), frequent PVC's (defined as 10 or more per minute), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, corrected QT interval \> 480 millisecond or other significant conduction defects
• Triglycerides \> 400 milligram/deciliter (md/dL) or Low-Density Lipoprotein (LDL) cholesterol \> 190 mg/dL
• Use of prescription or over-the-counter medications known to affect appetite, weight, heart rate response to exercise, or energy metabolism
• Use of systemic steroids (other than Oral Contraceptive Pills)
• Use of obesity pharmacotherapeutic agents within the last 6 months
• History of surgical procedure for weight loss
• History of major surgery within the past 3 months

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado, Anschutz Health and Wellness Center

Aurora, Colorado, 80045, United States

Location

Related Publications (4)

• Creasy SA, Ostendorf DM, Kaizer L, Rosenberg R, Breit MJ, Bessesen DH, Melanson EL, Catenacci VA. Effect of physical activity on changes in weight and aerobic capacity during an 18-month behavioral weight loss intervention. Int J Behav Nutr Phys Act. 2025 May 21;22(1):57. doi: 10.1186/s12966-025-01754-3.

  PMID: 40399945 DERIVED

• Creasy SA, Ostendorf DM, Blankenship JM, Grau L, Arbet J, Bessesen DH, Melanson EL, Catenacci VA. Effect of sleep on weight loss and adherence to diet and physical activity recommendations during an 18-month behavioral weight loss intervention. Int J Obes (Lond). 2022 Aug;46(8):1510-1517. doi: 10.1038/s41366-022-01141-z. Epub 2022 May 16.

  PMID: 35577898 DERIVED

• Ostendorf DM, Schmiege SJ, Conroy DE, Phelan S, Bryan AD, Catenacci VA. Motivational profiles and change in physical activity during a weight loss intervention: a secondary data analysis. Int J Behav Nutr Phys Act. 2021 Dec 4;18(1):158. doi: 10.1186/s12966-021-01225-5.

  PMID: 34863198 DERIVED

• Catenacci VA, Ostendorf DM, Pan Z, Bing K, Wayland LT, Seyoum E, Stauffer BL, Phelan S, Creasy SA, Caldwell AE, Wyatt HR, Bessesen DH, Melanson EL. The Impact of Timing of Exercise Initiation on Weight Loss: An 18-Month Randomized Clinical Trial. Obesity (Silver Spring). 2019 Nov;27(11):1828-1838. doi: 10.1002/oby.22624. Epub 2019 Sep 29.

  PMID: 31565869 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Motor Activity

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

Study Officials

• Victoria Catenacci, MD

  University of Colorado Anschutz Health and Wellness Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 15, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)