Clinical trial NCT01985568: Optimal Timing of Exercise Initiation Within a Lifestyle Weight Loss Program
Official title: Optimal Timing of Exercise Initiation Within a Lifestyle Weight Loss Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
weight-loss
Physical activity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-11-15
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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
* Capable and willing to give informed consent, understand exclusion criteria, and accept the randomized group assignment
* 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.

Exclusion Criteria:

* 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
* Current alcohol or substance abuse
* History of clinically diagnosed eating disorders including anorexia nervosa or bulimia
* Current severe depression or history of severe depression within the previous year
* History of other significant psychiatric illness (e.g. psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to dietary or exercise interventions
* Currently participating in or planning to participate in any formal weight loss or physical activity programs or clinical trials
* Weight loss or gain of \> 5% in past 6 months for any reason except post-partum weight loss
* Participation in a weight loss program using the Colorado Weigh curriculum within the past 3 years (exceptions can be made at the discretion of the study PI on a case-by-case basis).

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline, 3, 6, 9, 12, 15, and 18 months.
measure: Change in Body Composition
timeFrame: Baseline, 6, 12, and 18 months.
Secondary outcomes:
measure: Objectively Measured Change in Physical Activity
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Maximal Aerobic Capacity
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Diet Composition
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Engagement in Weight Control Eating Behaviors
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Dietary Weight Loss Program Attendance and Adherence
timeFrame: 18 months
measure: Change in Exercise Program Attendance and Adherence
timeFrame: 18 months
Other outcomes:
measure: Change in Number of Exercise Related Injuries and Adverse Events
timeFrame: 18 months
measure: Change in Mood
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Exercise Self-Efficacy
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Diet Self-Efficacy
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Beliefs About Exercise Benefits and Barriers
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Motivation to Engage in a Weight Loss Treatment Program
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Motivation to Engage in Exercise
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Physical Activity Enjoyment
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Dietary Self-Control
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Perceived Effort for Weight Control
timeFrame: Baseline, 6, 12, and 18 months.
measure: Change in Post intervention follow-up
timeFrame: 24 months
measure: Change in Genetic and Epigenetic markers
timeFrame: Baseline
Locations:
city: Aurora
country: United States
facility: University of Colorado, Anschutz Health and Wellness Center
state: Colorado
Study officials:
affiliation: University of Colorado Anschutz Health and Wellness Center
name: Victoria Catenacci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.