Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01408784
Other study ID # 172011
Secondary ID
Status Recruiting
Phase N/A
First received August 2, 2011
Last updated April 30, 2012
Start date July 2011
Est. completion date July 2012

Study information

Verified date July 2011
Source Assuta Hospital Systems
Contact Tzachi Knaan, M.Sc RD
Phone 972.522.785.274
Email knaan@inter.net.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 135
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:

- Ages 21-65

- Body mass index (BMI) between 20-45 kg/m2

- Workers of Maccabi Healthcare Services

- Members of Maccabi Healthcare Services

Exclusion Criteria:

-Clinical dietitians / Nutritionists

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Maccabi Healthcare Services Tel Aviv

Sponsors (3)

Lead Sponsor Collaborator
Assuta Hospital Systems Maccabi Healthcare Services, Israel, Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Calorie intake using "categories method" Sum of every meal (the average) 30-45 minutes No
Secondary Total calories per meal using "categories method" Average of a category 30-45 minutes No
See also
  Status Clinical Trial Phase
Completed NCT04120363 - Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations Phase 4
Completed NCT03303534 - Short-Term Endogenous Hydrogen Sulfide Upregulation N/A
Recruiting NCT04042415 - Calorie Restriction in Multiple Sclerosis N/A
Completed NCT04744142 - Effects of Ketones on Muscle Wasting During Caloric Restriction in Lean Females N/A
Completed NCT02734238 - Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery Phase 4