Study of the Effectiveness of Breakfast Recommendations On Reducing Body Weight
Randomized Controlled Trial of Breakfast Recommendations on Weight: A Multi-Site Effectiveness Trial
1 other identifier
interventional
309
2 countries
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jan 2013
Shorter than P25 for not_applicable obesity
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 3, 2013
CompletedFirst Posted
Study publicly available on registry
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFebruary 19, 2014
February 1, 2014
1 year
January 3, 2013
February 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Change in Body Mass Index
Difference between baseline and after 16 weeks
Study Arms (3)
General Nutrition Recommendations
ACTIVE COMPARATORParticipants 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.
Breakfast Recommendation
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Allison, Phdlead
- University of Copenhagencollaborator
- University of Colorado, Denvercollaborator
- Boston Universitycollaborator
- Columbia Universitycollaborator
Study Sites (5)
University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
Univeristy of Colorado Denver Anschutz Medical Campus
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
Related Publications (2)
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.
PMID: 1550038BACKGROUNDDhurandhar 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.
PMID: 24898236DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 3, 2013
First Posted
February 1, 2013
Study Start
January 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
February 19, 2014
Record last verified: 2014-02