14/21 Diet-walking in the Park

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Overweight: 25 <BMI <30

Intervention / Treatment
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* Behavioral: 14/21 diet


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 14/21 diet<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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14/21 diet, BMI, biochemical blood markers, quality of life