Study of the Effectiveness of Breakfast Recommendations On Reducing Body Weight

Obesity Clinical Trial

Official title:

Randomized Controlled Trial of Breakfast Recommendations on Weight: A Multi-Site Effectiveness Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781780
• Other study ID #: P30DK05633611
• Status: Completed
• Phase: N/A
• First received: January 3, 2013
• Last updated: February 16, 2014
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Food Habits
• Obesity

Intervention

Behavioral:
• General Nutrition Recommendations

• Breakfast Recommendation

• No Breakfast Recommendation

Locations

Country	Name	City	State
Denmark	Univeristy of Copenhagen	Copenhagen	Great Copenhagen
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston University, Boston Medical Center	Boston	Massachusetts
United States	Univeristy of Colorado Denver Anschutz Medical Campus	Denver	Colorado
United States	Columbia University	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
David Allison, Phd	Boston University, Columbia University, University of Colorado, Denver, University of Copenhagen

Countries where clinical trial is conducted

United States,  Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Body Mass Index	BMI will be calculated as kg/m2.	Difference between baseline and after 16 weeks	No