ObesityNCT02387827
Comparing of Long Bout and Short Bouts of Similar Volume of Walking in Obese on Weight Loss During a Weight Loss Program
A study testing Diet+ short term versus long -term physical activity in people with Obesity and Overweight, run by Novindiet Clinic at 1 site in Iran.
Trial summary
The purpose of this present study is to determine if a daily walking program of 50 continuous minutes (long bout) or two 25-minute bouts (short bouts) in similar volume on body weight, abdominal fat mass deposition and cardiometabolic measures in overweight and obese women receiving a low calorie diet for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Diet+ short term versus long -term physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Feb 2015to Feb 2016
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have Body mass index (BMI) between 27-35 kg/ m².
- were sedentary (reported exercising <20 min/d for the previous 6 month) and healthy
- Must be able to have moderate exercise.
- Must be interested to have weight loss.
Who cannot join
- Participating in a research project involving weight loss or physical activity in the previous six months.
- Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
- Taking medication that could affect metabolism or change body weight.
- Report heart problems, chest pain, and cancer within the last five years.
- Smoking
- Menopause
- Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this present study is to determine if a daily walking program of 50 continuous minutes (long bout) or two 25-minute bouts (short bouts) in similar volume on body weight, abdominal fat mass deposition and cardiometabolic measures in overweight and obese women receiving a low calorie diet for 24 weeks.
- Conditions
- Obesity, Overweight
- Being tested
- Diet+ short term versus long -term physical activity
- Keywords
- long bout physical activity, short bout physical activity, Caloric Restriction
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet+ short term versus long -term physical activityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Diet+ short -term physical activity (DST) | Experimental | Not described Receives: Behavioral: Diet+ short term versus long -term physical activity |
| Diet+ long -term physical activity (DLT) | Experimental | Not described Receives: Behavioral: Diet+ short term versus long -term physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 24 weeks
Body mass index reduction
Measured: 24 weeks
Secondary outcomes (4)
waist circumference
Measured: 24 weeks
Fasting plasma glucose level
Measured: 24 weeks
lipid profiles
Measured: 24 weeks
Insulin resistance (HOMA)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novindiet Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, Tehran University of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387827
- Sponsor's protocol ID
- ND-104
- Status last verified
- Apr 2017
- First submitted
- 9 Mar 2015
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Madjd A, Taylor MA, Delavari A, Malekzadeh R, Macdonald IA, Farshchi HR. Effect of a Long Bout Versus Short Bouts of Walking on Weight Loss During a Weight-Loss Diet: A Randomized Trial. Obesity (Silver Spring). 2019 Apr;27(4):551-558. doi: 10.1002/oby.22416. Epub 2019 Feb 9.
PubMed 30737894
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing of Long Bout and Short Bouts of Similar Volume of Walking in Obese on Weight Loss During a Weight Loss Program
- ClinicalTrials.gov ID
- NCT02387827
- Acronym / sponsor ID
- ND-104
- Conditions
- Obesity, Overweight
- Keywords
- long bout physical activity, short bout physical activity, Caloric Restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Novindiet ClinicUniversity, hospital or other
- Collaborators
- University of Nottingham, Tehran University of Medical Sciences
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 13 Mar 2015 (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 purpose of this present study is to determine if a daily walking program of 50 continuous minutes (long bout) or two 25-minute bouts (short bouts) in similar volume on body weight, abdominal fat mass deposition and cardiometabolic measures in overweight and obese women receiving a low calorie diet for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet+ short -term physical activity (DST) | Experimental | Behavioral: Diet+ short term versus long -term physical activity |
| Diet+ long -term physical activity (DLT) | Experimental | Behavioral: Diet+ short term versus long -term physical activity |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must have Body mass index (BMI) between 27-35 kg/ m².
- were sedentary (reported exercising <20 min/d for the previous 6 month) and healthy
- Must be able to have moderate exercise.
- Must be interested to have weight loss.
Key exclusion criteria (7 listed)
- Participating in a research project involving weight loss or physical activity in the previous six months.
- Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
- Taking medication that could affect metabolism or change body weight.
- Report heart problems, chest pain, and cancer within the last five years.
- Smoking
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 |
|---|---|---|
| Diet+ short term versus long -term physical activity | Behavioural | Diet+ long -term physical activity (DLT), Diet+ short -term physical activity (DST) |
Primary outcome
weight loss
Time frame: 24 weeks
Body mass index reduction
Time frame: 24 weeks
4 secondary outcomes
waist circumference
Time frame: 24 weeks
Fasting plasma glucose level
Time frame: 24 weeks
lipid profiles
Time frame: 24 weeks
Insulin resistance (HOMA)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Derived from this study: PubMed 30737894Madjd A, Taylor MA, Delavari A, Malekzadeh R, Macdonald IA, Farshchi HR. Effect of a Long Bout Versus Short Bouts of Walking on Weight Loss During a Weight-Loss Diet: A Randomized Trial. Obesity (Silver Spring). 2019 Apr;27(4):551-558. doi: 10.1002/oby.22416. Epub 2019 Feb 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet+ short term versus long -term physical activity in people with Obesity and Overweight, run by Novindiet Clinic at 1 site in Iran.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 4 Apr 2017. 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 Iran. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 loss (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02387827, which also lists 1 linked publication.
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 4 Apr 2017.