Study of the Effectiveness of Breakfast Recommendations On Reducing Body Weight
Status: | Completed |
---|---|
Conditions: | Food Studies, Obesity Weight Loss |
Therapuetic Areas: | Endocrinology, Pharmacology / Toxicology |
Healthy: | No |
Age Range: | 20 - 65 |
Updated: | 10/3/2013 |
Start Date: | January 2013 |
End Date: | August 2013 |
Contact: | Emily J Dhurandhar, PhD |
Email: | edhurand@uab.edu |
Phone: | 205-975-9194 |
Randomized Controlled Trial of Breakfast Recommendations on Weight: A Multi-Site Effectiveness Trial
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.
Inclusion Criteria:
- Ages 20-65
- Men and women
- BMI ≥25, and ≤45 kg/m2
- Interested in weight loss
- Start day by 9:00 a.m. at least 5 days a week
Exclusion Criteria:
- Participation in any weight-reduction program, weight-loss diet, or other special
diet within the previous 3 months.
- Weight loss or gain of >5% of body weight in the past 6 months for any reason except
post-partum weight loss.
- Currently taking medication that suppresses or stimulates appetite.
- Currently regularly taking medication that requires eating with food in the morning
as indicated on the prescription, or any non-steroidal anti-inflammatory drugs such
as baby aspirin or Tylenol.
- History of prior surgical procedure for weight control or liposuction.
- Current smoker or quit smoking less than 6 months prior.
- Any major disease, including:
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.
- A score on the Brief Symptom Inventory (BSI) (Derogatis & Melisaratos, 1983) that
exceeds the 90th percentile.
- History of or current eating disorders, or an Eating Attitudes Test (EAT-26) score
>20.
- Conditions or behaviors likely to effect the conduct of the trial: unable or
unwilling to give informed consent; unable to communicate with the pertinent clinic
staff; another household member is a participant or staff member in the trial;
unwilling to accept treatment assignment by randomization; current or anticipated
participation in another intervention research project that would interfere with the
intervention offered in the trial; likely to move away from participating clinics
before trial completed; unable to walk 0.25 mile in 10 minutes.
- Currently taking antidepressant, steroid, or thyroid medication, unless dosage has
been stable for at least 6 months.
- A recent or ongoing problem with drug abuse or addiction.
- Excessive alcohol intake, either acute or chronic defined as any one of the
following: 1) average consumption of 3 or more alcohol containing beverages daily; 2)
consumption of 7 or more alcoholic beverages within a 24-hr period in the past 12
months; or 3) other evidence available to clinic staff.
- Willing to be randomized to any of the three experimental conditions.
- Pregnancy and childbearing: currently pregnant or less than 3 months post partum;
currently nursing or within 6 weeks of having completed nursing; pregnancy
anticipated during study; unwilling to report possible or confirmed pregnancies
promptly during the course of the trial; unwilling to take adequate contraceptive
measures if potentially fertile.
- Any other conditions which, in opinion of the investigators, would adversely affect
the conduct of the trial.
We found this trial at
5
sites
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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