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Optimal Timing of Exercise Initiation Within a Lifestyle Weight Loss Program

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sequential BT
Standard BT
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, weight-loss, Physical activity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Colorado, Anschutz Health and Wellness Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Behavioral Therapy (Standard BT)

Sequential Behavioral Therapy (Sequential BT)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in Body Weight
Body weight will be assessed.
Change in Body Composition
Body composition will be assessed.

Secondary Outcome Measures

Objectively Measured Change in Physical Activity
Physical activity will be measured with activity monitors.
Change in Maximal Aerobic Capacity
Maximal aerobic capacity will be measured.
Change in Diet Composition
Dietary energy intake (calories/day) and fat intake (grams/day) will be measured.
Change in Engagement in Weight Control Eating Behaviors
Engagement in weight control eating behaviors will be measured with a questionnaire.
Change in Dietary Weight Loss Program Attendance and Adherence
Dietary weight loss program attendance and adherence will be assessed throughout the 18 month program.
Change in Exercise Program Attendance and Adherence
Exercise program attendance and adherence will be assessed throughout the 18 month program.

Full Information

First Posted
October 24, 2013
Last Updated
September 27, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01985568
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, weight-loss, Physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Behavioral Therapy (Standard BT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sequential Behavioral Therapy (Sequential BT)
Arm Type
Experimental
Arm Description
Sequential BT: This group will receive diet and exercise interventions delivered sequentially within an 18 month behavioral weight loss program.
Intervention Type
Behavioral
Intervention Name(s)
Sequential BT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard BT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
Body weight will be assessed.
Time Frame
Baseline, 3, 6, 9, 12, 15, and 18 months.
Title
Change in Body Composition
Description
Body composition will be assessed.
Time Frame
Baseline, 6, 12, and 18 months.
Secondary Outcome Measure Information:
Title
Objectively Measured Change in Physical Activity
Description
Physical activity will be measured with activity monitors.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Maximal Aerobic Capacity
Description
Maximal aerobic capacity will be measured.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Diet Composition
Description
Dietary energy intake (calories/day) and fat intake (grams/day) will be measured.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Engagement in Weight Control Eating Behaviors
Description
Engagement in weight control eating behaviors will be measured with a questionnaire.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Dietary Weight Loss Program Attendance and Adherence
Description
Dietary weight loss program attendance and adherence will be assessed throughout the 18 month program.
Time Frame
18 months
Title
Change in Exercise Program Attendance and Adherence
Description
Exercise program attendance and adherence will be assessed throughout the 18 month program.
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Change in Number of Exercise Related Injuries and Adverse Events
Description
Exercise related injuries and adverse events will be assessed throughout the 18 month program.
Time Frame
18 months
Title
Change in Mood
Description
Mood will be assessed with a questionnaire.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Exercise Self-Efficacy
Description
Exercise self-efficacy will be assessed with a questionnaire.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Diet Self-Efficacy
Description
Diet self-efficacy will be assessed with a questionnaire.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Beliefs About Exercise Benefits and Barriers
Description
Beliefs about exercise benefits and barriers will be assessed with a questionnaire.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Motivation to Engage in a Weight Loss Treatment Program
Description
Motivation for engaging in a weight-loss treatment program will be assessed with a questionnaire.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Motivation to Engage in Exercise
Description
Motivation to engage in exercise will be assessed with a questionnaire.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Physical Activity Enjoyment
Description
Physical activity enjoyment will be assessed with a questionnaire.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Dietary Self-Control
Description
Dietary self-control will be assessed with a questionnaire.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Perceived Effort for Weight Control
Description
Perceived effort for weight control will be measured with a questionnaire.
Time Frame
Baseline, 6, 12, and 18 months.
Title
Change in Post intervention follow-up
Description
Weight, objectively measured physical activity, and outcome measures #6 and #10-18 will be assessed 6 months after completion of intervention.
Time Frame
24 months
Title
Change in Genetic and Epigenetic markers
Description
Baseline genetic and epigenetic biomarkers will be analyzed to determine if they are associated with baseline measures and/or changes in post-intervention measure outcomes.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Catenacci, MD
Organizational Affiliation
University of Colorado Anschutz Health and Wellness Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado, Anschutz Health and Wellness Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35577898
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.
Results Reference
derived
PubMed Identifier
34863198
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.
Results Reference
derived
PubMed Identifier
31565869
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.
Results Reference
derived

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Optimal Timing of Exercise Initiation Within a Lifestyle Weight Loss Program

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