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14/21 Diet-walking in the Park

Primary Purpose

Overweight: 25 <BMI <30

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
14/21 diet
Sponsored by
Assuta Hospital Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight: 25 <BMI <30 focused on measuring 14/21 diet, BMI, biochemical blood markers, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Hebrew speaking 25<BMI<30 18 years old or older signed an informed consent

Exclusion Criteria:

Subjects who have a physical disability preventing them from exercise, Subjects who are pregnant or lactating, Subjects who are currently involved in another lifestyle intervention program, Subjects who had undergone bariatric surgery in the past, Subjects with: cancer, liver/kidney disease, organ transplantation, alcohol/drug addiction, Subjects that have cognitive deterioration or psychosis, vegetarians who does't eat fish/sea food or vegans

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Sites / Locations

  • Assuta medical centers

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

14/21 diet

Arm Description

Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days. The diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.

Outcomes

Primary Outcome Measures

Weight reduction
BMI will be calculated by the equation weight divided by square height.

Secondary Outcome Measures

Anthropometric measurements
Waist circumference will be measured at the level of the umbilicus. Hip circumference will be measured at the widest portion of the buttocks. Waist/hip ratio will be calculated. "Tanita" will be used for body composition analysis (%fat mass, fat mass,fat free mass and RMR).

Full Information

First Posted
October 21, 2013
Last Updated
November 24, 2013
Sponsor
Assuta Hospital Systems
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1. Study Identification

Unique Protocol Identification Number
NCT01991002
Brief Title
14/21 Diet-walking in the Park
Official Title
Prospective Interventional Study of the Impact of 3-step Diet With Complimentary Exercise Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assuta Hospital Systems

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The scientific literature shows a quantitative relationship between diet combined with physical activity as a long term weight reduction modality and an important factor in weight maintenance. Primary assumption - the 14/21 diet will have an impact on BMI values, and their long-term maintenance. Secondary assumption - the 14/21 diet will have a positive impact on anthropomorphic and biochemical markers, on blood pressure, resting heart rate, RMR, and life quality.
Detailed Description
An interventional part for a duration of 56 days and a follow-up period including monitoring of different parameters. Follow up session are set to 3, 6, 12 and 24 months from the end of the interventional period. Participants will be recruited in several rounds, each including up to 25 participants. Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days. The diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.During the intervention period subjects will meet for walking. In addition, 30 minutes of aerobic exercise will be recommended 3 times/week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight: 25 <BMI <30
Keywords
14/21 diet, BMI, biochemical blood markers, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
14/21 diet
Arm Type
Other
Arm Description
Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days. The diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.
Intervention Type
Behavioral
Intervention Name(s)
14/21 diet
Intervention Description
Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days. The diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.
Primary Outcome Measure Information:
Title
Weight reduction
Description
BMI will be calculated by the equation weight divided by square height.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Anthropometric measurements
Description
Waist circumference will be measured at the level of the umbilicus. Hip circumference will be measured at the widest portion of the buttocks. Waist/hip ratio will be calculated. "Tanita" will be used for body composition analysis (%fat mass, fat mass,fat free mass and RMR).
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Biochemical markers
Description
To measure glucose, HbA1C (Glycated hemoglobin), blood fat profile, liver enzymes, inflammatory markers.
Time Frame
2 years
Title
Blood pressure
Description
Blood pressure will be measured.
Time Frame
2 years
Title
Quality of life.
Description
Visual Analog Scale questionnaire and SF-12 questionnaire will be filled out by the subjects.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Hebrew speaking 25<BMI<30 18 years old or older signed an informed consent Exclusion Criteria: Subjects who have a physical disability preventing them from exercise, Subjects who are pregnant or lactating, Subjects who are currently involved in another lifestyle intervention program, Subjects who had undergone bariatric surgery in the past, Subjects with: cancer, liver/kidney disease, organ transplantation, alcohol/drug addiction, Subjects that have cognitive deterioration or psychosis, vegetarians who does't eat fish/sea food or vegans -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Shemer, Prof.
Organizational Affiliation
Assuta Hospital Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuta medical centers
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

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14/21 Diet-walking in the Park

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