Optimal Timing of Exercise Initiation Within a Lifestyle Weight Loss Program

Obesity Clinical Trial

Official title:

Optimal Timing of Exercise Initiation Within a Lifestyle Weight Loss Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985568
• Other study ID #: 13-1550
• Secondary ID: R01DK097266
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: September 2018

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Colorado, Anschutz Health and Wellness Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Number of Exercise Related Injuries and Adverse Events	Exercise related injuries and adverse events will be assessed throughout the 18 month program.	18 months
Other	Change in Mood	Mood will be assessed with a questionnaire.	Baseline, 6, 12, and 18 months.
Other	Change in Exercise Self-Efficacy	Exercise self-efficacy will be assessed with a questionnaire.	Baseline, 6, 12, and 18 months.
Other	Change in Diet Self-Efficacy	Diet self-efficacy will be assessed with a questionnaire.	Baseline, 6, 12, and 18 months.
Other	Change in Beliefs About Exercise Benefits and Barriers	Beliefs about exercise benefits and barriers will be assessed with a questionnaire.	Baseline, 6, 12, and 18 months.
Other	Change in Motivation to Engage in a Weight Loss Treatment Program	Motivation for engaging in a weight-loss treatment program will be assessed with a questionnaire.	Baseline, 6, 12, and 18 months.
Other	Change in Motivation to Engage in Exercise	Motivation to engage in exercise will be assessed with a questionnaire.	Baseline, 6, 12, and 18 months.
Other	Change in Physical Activity Enjoyment	Physical activity enjoyment will be assessed with a questionnaire.	Baseline, 6, 12, and 18 months.
Other	Change in Dietary Self-Control	Dietary self-control will be assessed with a questionnaire.	Baseline, 6, 12, and 18 months.
Other	Change in Perceived Effort for Weight Control	Perceived effort for weight control will be measured with a questionnaire.	Baseline, 6, 12, and 18 months.
Other	Change in Post intervention follow-up	Weight, objectively measured physical activity, and outcome measures #6 and #10-18 will be assessed 6 months after completion of intervention.	24 months
Other	Change in Genetic and Epigenetic markers	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
Primary	Change in Body Weight	Body weight will be assessed.	Baseline, 3, 6, 9, 12, 15, and 18 months.
Primary	Change in Body Composition	Body composition will be assessed.	Baseline, 6, 12, and 18 months.
Secondary	Objectively Measured Change in Physical Activity	Physical activity will be measured with activity monitors.	Baseline, 6, 12, and 18 months.
Secondary	Change in Maximal Aerobic Capacity	Maximal aerobic capacity will be measured.	Baseline, 6, 12, and 18 months.
Secondary	Change in Diet Composition	Dietary energy intake (calories/day) and fat intake (grams/day) will be measured.	Baseline, 6, 12, and 18 months.
Secondary	Change in Engagement in Weight Control Eating Behaviors	Engagement in weight control eating behaviors will be measured with a questionnaire.	Baseline, 6, 12, and 18 months.
Secondary	Change in Dietary Weight Loss Program Attendance and Adherence	Dietary weight loss program attendance and adherence will be assessed throughout the 18 month program.	18 months
Secondary	Change in Exercise Program Attendance and Adherence	Exercise program attendance and adherence will be assessed throughout the 18 month program.	18 months