14/21 Diet-walking in the Park

Prospective Interventional Study of the Impact of 3-step Diet With Complimentary Exercise Program

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.

Study Overview

• Status: Unknown
• Conditions: Overweight: 25
• Intervention / Treatment: Behavioral: 14/21 diet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Assuta Medical Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 14/21 diet; 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.

Behavioral: 14/21 diet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight reduction	BMI will be calculated by the equation weight divided by square height.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical markers	To measure glucose, HbA1C (Glycated hemoglobin), blood fat profile, liver enzymes, inflammatory markers.	2 years
Blood pressure	Blood pressure will be measured.	2 years
Quality of life.	Visual Analog Scale questionnaire and SF-12 questionnaire will be filled out by the subjects.	2 years

Collaborators and Investigators

• Sponsor: Assuta Hospital Systems
• Investigators: Principal Investigator: Joshua Shemer, Prof., Assuta Hospital Systems

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: November 17, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): November 26, 2013
• Last Update Submitted That Met QC Criteria: November 24, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: quality of life; BMI; 14/21 diet; biochemical blood markers
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: diet003