Trial record 5 of 40 for:    Open Studies | "Weight Reduction Programs"

Optimal Timing of Exercise Initiation Within a Lifestyle Weight Loss Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01985568
First received: October 24, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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. Our 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.


Condition Intervention
Obesity
Behavioral: Sequential BT
Behavioral: Standard BT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimal Timing of Exercise Initiation Within a Lifestyle Weight Loss Program

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Body Weight [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Body weight will be assessed at baseline, 3, 6, 9, 12, 15, and 18 months.

  • Body Composition [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Body composition will be assessed at baseline, 6, 12, and 18 months.


Secondary Outcome Measures:
  • Objectively Measured Physical Activity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Physical activity will be measured with activity monitors at baseline, 6, 12, and 18 months.

  • Maximal Aerobic Capacity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Maximal aerobic capacity will be measures at baseline, 6, 12, and 18 months.

  • Diet Composition [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Dietary energy intake (calories/day) and fat intake (grams/day) will be measured at baseline, 6, 12 and 18 months.

  • Engagement in Weight Control Eating Behaviors [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Engagement in weight control eating behaviors will be measured with a questionnaire at baseline, 6, 12, and 18 months.

  • Dietary Weight Loss Program Attendance and Adherence [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Dietary weight loss program attendance and adherence will be assessed throughout the 18 month program.

  • Exercise Program Attendance and Adherence [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Exercise program attendance and adherence will be assessed throughout the 18 month program.


Other Outcome Measures:
  • Number of Exercise Related Injuries and Adverse Events [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Exercise related injuries and adverse events will be assessed throughout the 18 month program.

  • Mood [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Mood will be assessed with a questionnaire at baseline, 6, 12, and 18 months.

  • Exercise Self-Efficacy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Exercise self-efficacy will be assessed with a questionnaire at baseline, 6, 12, and 18 months.

  • Diet Self-Efficacy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Diet self-efficacy will be assessed with a questionnaire at baseline, 6, 12, and 18 months.

  • Beliefs About Exercise Benefits and Barriers [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Beliefs about exercise benefits and barriers will be assessed with a questionnaire at baseline, 6, 12, and 18 months.

  • Motivation to Engage in a Weight Loss Treatment Program [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Motivation for engaging in a weight-loss treatment program will be assessed with a questionnaire at baseline, 6, 12, and 18 months.

  • Motivation to Engage in Exercise [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Motivation to engage in exercise will be assessed with a questionnaire at baseline, 6, 12, and 18 months.

  • Physical Activity Enjoyment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Physical activity enjoyment will be assessed with a questionnaire at baseline, 6, 12, and 18 months.

  • Dietary Self-Control [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Dietary self-control will be assessed with a questionnaire at baseline, 6, 12, and 18 months.

  • Perceived Effort for Weight Control [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Perceived effort for weight control will be measured with a questionnaire at baseline, 6, 12, and 18 months.


Estimated Enrollment: 150
Study Start Date: November 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 15 miles 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

    • Pre-menopausal status
    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985568

Contacts
Contact: Kristen Bing, RD kristen.bing@ucdenver.edu

Locations
United States, Colorado
University of Colorado, Anschutz Health and Wellness Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Kristen Bing, RD       kristen.bing@ucdenver.edu   
Principal Investigator: Victoria Catenacci, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Victoria Catenacci, MD University of Colorado Anschutz Health and Wellness Center
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01985568     History of Changes
Other Study ID Numbers: 13-1550, R01DK097266
Study First Received: October 24, 2013
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Obesity
weight-loss
Physical activity

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 19, 2014