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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK097266 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Behavioral Therapy (Standard BT) | Active Comparator | 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. |
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| Sequential Behavioral Therapy (Sequential BT) | Experimental | Sequential BT: This group will receive diet and exercise interventions delivered sequentially within an 18 month behavioral weight loss program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequential BT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Body weight will be assessed. | Baseline, 3, 6, 9, 12, 15, and 18 months. |
| Change in Body Composition | Body composition will be assessed. | Baseline, 6, 12, and 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Objectively Measured Change in Physical Activity | Physical activity will be measured with activity monitors. | Baseline, 6, 12, and 18 months. |
| Change in Maximal Aerobic Capacity | Maximal aerobic capacity will be measured. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Mood | Mood will be assessed with a questionnaire. |
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Catenacci, MD | University of Colorado Anschutz Health and Wellness Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado, Anschutz Health and Wellness Center | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40399945 | Derived | Creasy SA, Ostendorf DM, Kaizer L, Rosenberg R, Breit MJ, Bessesen DH, Melanson EL, Catenacci VA. Effect of physical activity on changes in weight and aerobic capacity during an 18-month behavioral weight loss intervention. Int J Behav Nutr Phys Act. 2025 May 21;22(1):57. doi: 10.1186/s12966-025-01754-3. | |
| 35577898 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Standard BT | Behavioral | 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. |
|
| Baseline, 6, 12, and 18 months. |
| Change in Diet Composition | 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 | 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 | Dietary weight loss program attendance and adherence will be assessed throughout the 18 month program. | 18 months |
| Change in Exercise Program Attendance and Adherence | Exercise program attendance and adherence will be assessed throughout the 18 month program. | 18 months |
| Baseline, 6, 12, and 18 months. |
| Change in Exercise Self-Efficacy | Exercise self-efficacy will be assessed with a questionnaire. | Baseline, 6, 12, and 18 months. |
| Change in Diet Self-Efficacy | Diet self-efficacy will be assessed with a questionnaire. | Baseline, 6, 12, and 18 months. |
| 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. |
| 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. |
| Change in Motivation to Engage in Exercise | Motivation to engage in exercise will be assessed with a questionnaire. | Baseline, 6, 12, and 18 months. |
| Change in Physical Activity Enjoyment | Physical activity enjoyment will be assessed with a questionnaire. | Baseline, 6, 12, and 18 months. |
| Change in Dietary Self-Control | Dietary self-control will be assessed with a questionnaire. | Baseline, 6, 12, and 18 months. |
| Change in Perceived Effort for Weight Control | Perceived effort for weight control will be measured with a questionnaire. | Baseline, 6, 12, and 18 months. |
| 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 |
| 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 |
| 34863198 | Derived | 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. |
| 31565869 | Derived | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |