Study of the Effectiveness of Breakfast Recommendations On Reducing Body Weight

February 16, 2014 updated by: David Allison, Phd

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

309

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Great Copenhagen
      • Copenhagen, Great Copenhagen, Denmark, 1017
        • Univeristy of Copenhagen
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama at Birmingham
    • Colorado
      • Denver, Colorado, United States
        • Univeristy of Colorado Denver Anschutz Medical Campus
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University, Boston Medical Center
    • New York
      • New York, New York, United States, 10027
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: General Nutrition Recommendations
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.
Behavioral: General Nutrition Recommendations
Experimental: Breakfast Recommendation
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.
Behavioral: Breakfast Recommendation
Experimental: No Breakfast Recommendation
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.
Behavioral: No Breakfast Recommendation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight Change
Time Frame: Difference between baseline, and after 16 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index
Time Frame: Difference between baseline and after 16 weeks
BMI will be calculated as kg/m2.
Difference between baseline and after 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Allison, Phd

Collaborators

Boston University
University of Colorado, Denver
Columbia University
University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 3, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

February 1, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 16, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P30DK05633611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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