University of Colorado, Anschutz Health and Wellness Center
Aurora, Colorado, 80045, United States
NCT Number: NCT01985568
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.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, 3, 6, 9, 12, 15, and 18 months.
Body weight will be assessed.
Time frame: Baseline, 6, 12, and 18 months.
Body composition will be assessed.
Time frame: Baseline, 6, 12, and 18 months.
Physical activity will be measured with activity monitors.
Time frame: Baseline, 6, 12, and 18 months.
Maximal aerobic capacity will be measured.
Time frame: Baseline, 6, 12, and 18 months.
Dietary energy intake (calories/day) and fat intake (grams/day) will be measured.
Time frame: Baseline, 6, 12, and 18 months.
Engagement in weight control eating behaviors will be measured with a questionnaire.
Time frame: 18 months
Dietary weight loss program attendance and adherence will be assessed throughout the 18 month program.
Time frame: 18 months
Exercise program attendance and adherence will be assessed throughout the 18 month program.
Time frame: 18 months
Exercise related injuries and adverse events will be assessed throughout the 18 month program.
Time frame: Baseline, 6, 12, and 18 months.
Mood will be assessed with a questionnaire.
Time frame: Baseline, 6, 12, and 18 months.
Exercise self-efficacy will be assessed with a questionnaire.
Time frame: Baseline, 6, 12, and 18 months.
Diet self-efficacy will be assessed with a questionnaire.
Time frame: Baseline, 6, 12, and 18 months.
Beliefs about exercise benefits and barriers will be assessed with a questionnaire.
Time frame: Baseline, 6, 12, and 18 months.
Motivation for engaging in a weight-loss treatment program will be assessed with a questionnaire.
Time frame: Baseline, 6, 12, and 18 months.
Motivation to engage in exercise will be assessed with a questionnaire.
Time frame: Baseline, 6, 12, and 18 months.
Physical activity enjoyment will be assessed with a questionnaire.
Time frame: Baseline, 6, 12, and 18 months.
Dietary self-control will be assessed with a questionnaire.
Time frame: Baseline, 6, 12, and 18 months.
Perceived effort for weight control will be measured with a questionnaire.
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.
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.
University of Colorado, Denver
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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