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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| University of Colorado, Denver | OTHER |
| Boston University | OTHER |
| Columbia University |
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This is an experiment that will compare the effect of recommending breakfast consumption, or breakfast skipping, on body weight. Our objective is to determine if breakfast consumption recommendations can produce weight loss, and if that weight loss is dependent on typical breakfast eating habits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Nutrition Recommendations | Active Comparator | Participants will be provided with a free USDA nutrition pamphlet describing general good nutrition habits. They will also receive an instruction handout to emphasize some of the points in the dietary guidelines in the handout. The clinician will go through both documents with participants in detail by reading them aloud and answering any questions, and it will be recommended that they incorporate the suggestions as best they can into their daily life. |
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| Breakfast Recommendation | Experimental | Participants randomized to the breakfast group will be instructed to consume breakfast before 10:00 a.m. every day, and will be asked to not eat again until after 11:00 a.m. Participants will be counseled on what a healthy breakfast is using an instruction handout. No specific restrictions will be given on types of foods that can be consumed for the breakfast meal. They will be instructed to keep track of their breakfast consumption (yes/no) using a calendar diary that will be provided to them. Participants will also be provided with a free USDA nutrition pamphlet describing general good nutrition habits. The clinician will go through both documents with participants in detail by reading them aloud and answering any questions, and it will be recommended that they incorporate the recommendations into their daily life as much as they can. |
|
| No Breakfast Recommendation | Experimental | Participants randomized to the no breakfast group will receive a detailed handout with instructions to not consume any calories before 11:00 a.m. every day. Only water or 0 calorie beverages may be consumed from the time of waking until 11:00 a.m. They will be instructed to keep track of their breakfast consumption (yes/no) using a calendar diary that will be provided to them. Participants will also provided with a free USDA nutrition pamphlet describing general good nutrition habits. The clinician will go through both documents with participants in detail by reading them aloud and answering any questions, and it will be recommended that they incorporate the recommendations into their daily life as much as they can. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General Nutrition Recommendations | Behavioral |
| ||
| Breakfast Recommendation |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight Change | Weight will be measured in light indoor clothes without shoes. Weight measurements will be recorded to the nearest 0.1 kg using a digital scale. | Difference between baseline, and after 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index | BMI will be calculated as kg/m2. | Difference between baseline and after 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).
Active or chronic infections, including self-reported HIV positivity and active tuberculosis.
Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease (e.g., coronary artery bypass, percutaneous transluminal coronary angioplasty) in the past 6 months; New York Heart Association Functional Class >2 with respect to congestive heart failure; stroke or transient ischemic attack in the past 6 months.
Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
Active renal disease. Lung disease: chronic obstructive airway disease requiring use of oxygen. Diagnosed diabetes (type 1 or 2) and taking any anti-diabetic medications and/or controlling the disease via dietary manipulations.
Uncompensated or uncontrolled psychiatric disease (such as schizophrenia and bipolar disorder) that, in opinion of the investigators, would impede conduct of the trial or completion of procedures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States | ||
| Univeristy of Colorado Denver Anschutz Medical Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1550038 | Background | Schlundt DG, Hill JO, Sbrocco T, Pope-Cordle J, Sharp T. The role of breakfast in the treatment of obesity: a randomized clinical trial. Am J Clin Nutr. 1992 Mar;55(3):645-51. doi: 10.1093/ajcn/55.3.645. | |
| 24898236 | Derived | Dhurandhar EJ, Dawson J, Alcorn A, Larsen LH, Thomas EA, Cardel M, Bourland AC, Astrup A, St-Onge MP, Hill JO, Apovian CM, Shikany JM, Allison DB. The effectiveness of breakfast recommendations on weight loss: a randomized controlled trial. Am J Clin Nutr. 2014 Aug;100(2):507-13. doi: 10.3945/ajcn.114.089573. Epub 2014 Jun 4. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D005247 | Feeding Behavior |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
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| Behavioral |
|
| No Breakfast Recommendation | Behavioral |
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| Denver |
| Colorado |
| United States |
| Boston University, Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Columbia University | New York | New York | 10027 | United States |
| Univeristy of Copenhagen | Copenhagen | Great Copenhagen | 1017 | Denmark |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D001836 | Body Weight Changes |