Optimal Timing of Exercise Initiation Within a Lifestyle Weight Loss Program

September 27, 2023 updated by: University of Colorado, Denver
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Anschutz Health and Wellness Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Behavioral Therapy (Standard BT)
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
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.
Experimental: Sequential Behavioral Therapy (Sequential BT)
Sequential BT: This group will receive diet and exercise interventions delivered sequentially within an 18 month behavioral weight loss program.
Behavioral: Sequential BT
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: Baseline, 3, 6, 9, 12, 15, and 18 months.
Body weight will be assessed.
Baseline, 3, 6, 9, 12, 15, and 18 months.
Change in Body Composition
Time Frame: Baseline, 6, 12, and 18 months.
Body composition will be assessed.
Baseline, 6, 12, and 18 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objectively Measured Change in Physical Activity
Time Frame: Baseline, 6, 12, and 18 months.
Physical activity will be measured with activity monitors.
Baseline, 6, 12, and 18 months.
Change in Maximal Aerobic Capacity
Time Frame: Baseline, 6, 12, and 18 months.
Maximal aerobic capacity will be measured.
Baseline, 6, 12, and 18 months.
Change in Diet Composition
Time Frame: Baseline, 6, 12, and 18 months.
Dietary energy intake (calories/day) and fat intake (grams/day) will be measured.
Baseline, 6, 12, and 18 months.
Change in Engagement in Weight Control Eating Behaviors
Time Frame: Baseline, 6, 12, and 18 months.
Engagement in weight control eating behaviors will be measured with a questionnaire.
Baseline, 6, 12, and 18 months.
Change in Dietary Weight Loss Program Attendance and Adherence
Time Frame: 18 months
Dietary weight loss program attendance and adherence will be assessed throughout the 18 month program.
18 months
Change in Exercise Program Attendance and Adherence
Time Frame: 18 months
Exercise program attendance and adherence will be assessed throughout the 18 month program.
18 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Number of Exercise Related Injuries and Adverse Events
Time Frame: 18 months
Exercise related injuries and adverse events will be assessed throughout the 18 month program.
18 months
Change in Mood
Time Frame: Baseline, 6, 12, and 18 months.
Mood will be assessed with a questionnaire.
Baseline, 6, 12, and 18 months.
Change in Exercise Self-Efficacy
Time Frame: Baseline, 6, 12, and 18 months.
Exercise self-efficacy will be assessed with a questionnaire.
Baseline, 6, 12, and 18 months.
Change in Diet Self-Efficacy
Time Frame: Baseline, 6, 12, and 18 months.
Diet self-efficacy will be assessed with a questionnaire.
Baseline, 6, 12, and 18 months.
Change in Beliefs About Exercise Benefits and Barriers
Time Frame: Baseline, 6, 12, and 18 months.
Beliefs about exercise benefits and barriers will be assessed with a questionnaire.
Baseline, 6, 12, and 18 months.
Change in Motivation to Engage in a Weight Loss Treatment Program
Time Frame: Baseline, 6, 12, and 18 months.
Motivation for engaging in a weight-loss treatment program will be assessed with a questionnaire.
Baseline, 6, 12, and 18 months.
Change in Motivation to Engage in Exercise
Time Frame: Baseline, 6, 12, and 18 months.
Motivation to engage in exercise will be assessed with a questionnaire.
Baseline, 6, 12, and 18 months.
Change in Physical Activity Enjoyment
Time Frame: Baseline, 6, 12, and 18 months.
Physical activity enjoyment will be assessed with a questionnaire.
Baseline, 6, 12, and 18 months.
Change in Dietary Self-Control
Time Frame: Baseline, 6, 12, and 18 months.
Dietary self-control will be assessed with a questionnaire.
Baseline, 6, 12, and 18 months.
Change in Perceived Effort for Weight Control
Time Frame: Baseline, 6, 12, and 18 months.
Perceived effort for weight control will be measured with a questionnaire.
Baseline, 6, 12, and 18 months.
Change in Post intervention follow-up
Time Frame: 24 months
Weight, objectively measured physical activity, and outcome measures #6 and #10-18 will be assessed 6 months after completion of intervention.
24 months
Change in Genetic and Epigenetic markers
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Victoria Catenacci, MD, University of Colorado Anschutz Health and Wellness Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13-1550
  • R01DK097266 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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