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Diet RecordsNCT01408784

A New Method for Self-assessment of Daily Calorie Intake

An observational study of Diet Records and Caloric Restriction, run by Assuta Hospital Systems at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess the validity of self-caloric evaluation, the "categories method" - a new method based on one categorical score per meal Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Diet Records, Caloric Restriction
How many people
135 participants
Where
1 siteIsrael
Study dates
Jul 2011to Jul 2012
Phase
Observational
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 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Community sample

Who may be able to join

  • Ages 21-65
  • Body mass index (BMI) between 20-45 kg/m2
  • Workers of Maccabi Healthcare Services
  • Members of Maccabi Healthcare Services

Who cannot join

  • -Clinical dietitians / Nutritionists

Trial locations and contacts

1 site in 1 country.

Tzachi Knaan, M.Sc RD contact

972.522.785.274

knaan@inter.net.il

Ronit Endevelt, PhD contact

972.35143777

endevelt_r@mac.org.il

Israel1 site, 1 recruiting
  • Maccabi Healthcare Services

    Tel Aviv

    Tzachi Knaan, M.Sc RD, 972.522.785.274, knaan@inter.net.il

    Tzachi Knaan, M.Sc RD

    Recruiting

Other trials in Israel

About this study

Official title: Evaluating the Validity of the "Categories" Method: a New Method for Self-report Assessment of Daily Calorie Intake

The purpose of this study is to assess the validity of self-caloric evaluation, the "categories method" - a new method based on one categorical score per meal

Read the detailed description

Weight loss is mainly a result of reduction in daily caloric intake. Hence many people are interested in counting and tracking their daily caloric intake but In fact only 9% of people in the USA can accurately estimate the number of calories they eat (International Food Information Council Foundation, May 2011)

According to the well-known method the investigators need to know the caloric value of each and every component our dish or meal. For example: a Breakfast that contains a glass of orange juice, a small bagel, spread with cream cheese shall be calculated as : orange juice 90 kcal + bagel 192 kcal +cream cheese 98 kcal=total 380 kcal.

This method is very complicated, especially when the investigators need to calculate a dish that its ingredients are not straightforward such as: Cob salad or Shepherd's pie, Even a slice of pizza, it is very difficult to estimate the fat, carbohydrate or protein a piece of pie contains let alone the caloric volume.

The investigators proposed a new method called "The categories method": a single categorical estimation per meal based on a set of five categories:

Category 1 less than 200 kcal, Category 2 200-500 kcal, Category 3 501-800 kcal, Category 4 801-1200 kcal, Category 5 above 1200 kcal

After choosing the category the investigators use an average of the category (e.g., category 3: 500-800 Avg = 650 kcal). Using the same Breakfast description as above: this meal will be considered as category No. 2 (200-500 Kcal), and chicken and rice at the restaurant will considered as a category 4 (800-1200 Kcal).

This method simplifies the process of counting calories, especially with assembled or cooked meal, it makes it easier to track any given meal even to those how are not so familiar with the caloric value of a product.

Research protocol:Participates will interviewed face to face on 1 occasion to obtain 24 hours recall using 4 pass method include 1. Quick review of the meals. 2. Food items that may be forgotten 3. Time and place of each meal 4. Assessment of food quantities and dimensions using a photograph published by the Israeli Ministry

This method is implemented with U.S. Department of Agriculture (USDA) as part of nutritional surveys and is used for "MBT" Survey of the Israeli Ministry of Health

Using "Tzameret" software system (food composition program of the Israeli Ministry of Health) The investigators will input the 24HR recall food list and quantity to calculate caloric values for every meal and the total calorie intake.

Using the "Categories Method" the investigators will calculate the caloric value of a meal by giving the average value of each category (record in parentheses).

Finally, reliability of the "categories method" compare with the 24HR recall will statistically calculated.

Keywords
calories, counting, obesity, overweight, categories, calorie, method, counting calories, lose weight, diet, energy balance, energy intake, 24 hours recall, food intake
Medical subject headings
Obesity, Overweight, Weight Loss

What is being measured

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

  1. Total Calorie intake using "categories method"

    Sum of every meal (the average)

    Measured: 30-45 minutes

Secondary outcomes (1)
  1. Total calories per meal using "categories method"

    Average of a category

    Measured: 30-45 minutes

Timeline

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

  1. First posted3 Aug 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJul 2012 (estimated)
  4. Study completionJul 2012 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01408784
Sponsor's protocol ID
172011
Status last verified
Jul 2011
First submitted
2 Aug 2011
Last updated
1 May 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Diet Records and Caloric Restriction, run by Assuta Hospital Systems at 1 site in Israel.

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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. 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?

Results are not available in the source record.

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

Contact Tzachi Knaan, M.Sc RD (972.522.785.274, knaan@inter.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Calorie intake using "categories method" (time frame: 30-45 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 May 2012; AzTrials last refreshed its copy on 7 Nov 2026.

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