NCT01408784

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 1, 2012

Status Verified

July 1, 2011

Enrollment Period

1 year

First QC Date

August 2, 2011

Last Update Submit

April 30, 2012

Conditions

Diet RecordsCaloric Restriction

Keywords

caloriescountingobesityoverweightcategoriescaloriemethodcounting calorieslose weightdietenergy balanceenergy intake24 hours recallfood intake

Outcome Measures

Primary Outcomes (1)

  • Total Calorie intake using "categories method"

    Sum of every meal (the average)

    30-45 minutes

Secondary Outcomes (1)

  • Total calories per meal using "categories method"

    30-45 minutes

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

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

You may not qualify if:

  • Clinical dietitians / Nutritionists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maccabi Healthcare Services

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Orit Klinger, MD

    Maccabi Healthcare Services, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzachi Knaan, M.Sc RD

CONTACT

972.522.785.274knaan@inter.net.il

Ronit Endevelt, PhD

CONTACT

972.35143777endevelt_r@mac.org.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 3, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

May 1, 2012

Record last verified: 2011-07

Locations

IL(1)