Overweight: 25 <BMI <30NCT01991002
14/21 Diet-walking in the Park
A study testing 14/21 diet in people with Overweight: 25 <BMI <30, run by Assuta Hospital Systems at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight: 25 <BMI <30
- What is being tested?
- 14/21 diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hebrew speaking 25<BMI<30 18 years old or older signed an informed consent
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight: 25 <BMI <30
- Being tested
- 14/21 diet
- Keywords
- 14/21 diet, BMI, biochemical blood markers, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14/21 dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 14/21 diet | Other | 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. Receives: Behavioral: 14/21 diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight reduction
BMI will be calculated by the equation weight divided by square height.
Measured: 2 years
Secondary outcomes (1)
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJul 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight: 25 <BMI <30Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Sh.Shemer, Assuta Hospital Systems
- Investigators
- Joshua Shemer, Prof., Principal investigator, Assuta Hospital Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991002
- Sponsor's protocol ID
- diet003
- Status last verified
- Nov 2013
- First submitted
- 21 Oct 2013
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Interventional Study of the Impact of 3-step Diet With Complimentary Exercise Program
- ClinicalTrials.gov ID
- NCT01991002
- Acronym / sponsor ID
- diet003
- Conditions
- Overweight: 25 <BMI <30
- Keywords
- 14/21 diet, BMI, biochemical blood markers, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14/21 diet | Other | Behavioral: 14/21 dietDiet 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hebrew speaking 25<BMI<30 18 years old or older signed an informed consent
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14/21 dietDiet 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. | Behavioural | 14/21 diet |
Primary outcome
Weight reduction
Time frame: 2 years
BMI will be calculated by the equation weight divided by square height.
1 secondary outcome
Anthropometric measurements
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Shemer, Prof. principal investigator
Assuta Hospital Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 14/21 diet in people with Overweight: 25 <BMI <30, run by Assuta Hospital Systems at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight reduction (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.