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ObesityNCT01781780

Study of the Effectiveness of Breakfast Recommendations On Reducing Body Weight

A study testing General Nutrition Recommendations, Breakfast Recommendation and No Breakfast Recommendation in people with Obesity and Food Habits, run by David Allison, Phd at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Food Habits
What is being tested?
General Nutrition Recommendations, Breakfast Recommendation and No Breakfast Recommendation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
309 participants
Where
5 sitesin 2 countries
Study dates
Jan 2013to Jan 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

  • Boston University, Boston Medical Center

    Boston, Massachusetts, 02118

  • Univeristy of Colorado Denver Anschutz Medical Campus

    Denver, Colorado

  • Columbia University

    New York, New York, 10027

Other trials in United States

Denmark1 site

  • Univeristy of Copenhagen

    Copenhagen, Great Copenhagen, 1017

Other trials in Denmark

About this study

Official title: 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.

Conditions
Obesity, Food Habits
Being tested
General Nutrition Recommendations, Breakfast Recommendation, No Breakfast Recommendation
Keywords
Obesity, Weight Loss, Breakfast
Medical subject headings
Obesity, Feeding Behavior, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • General Nutrition RecommendationsBehavioural

  • Breakfast RecommendationBehavioural

  • No Breakfast RecommendationBehavioural

Study groups in NCT01781780
Study groupRoleWhat they receive
General Nutrition RecommendationsActive 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.
Receives: Behavioral: General Nutrition Recommendations
Breakfast RecommendationExperimentalParticipants 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.
Receives: Behavioral: Breakfast Recommendation
No Breakfast RecommendationExperimentalParticipants 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.
Receives: Behavioral: No Breakfast Recommendation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Difference between baseline, and after 16 weeks

Secondary outcomes (1)

  1. Change in Body Mass Index

    BMI will be calculated as kg/m2.

    Measured: Difference between baseline and after 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
309 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01781780
Sponsor's protocol ID
P30DK05633611
Status last verified
Feb 2014
First submitted
3 Jan 2013
Last updated
19 Feb 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 1550038

  • 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.

    PubMed 24898236

Questions about this trial

What is this clinical trial studying?

A study testing General Nutrition Recommendations, Breakfast Recommendation and No Breakfast Recommendation in people with Obesity and Food Habits, run by David Allison, Phd at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight Change (time frame: Difference between baseline, and after 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01781780, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.

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