ObesityNCT02398253
Effects of Cognitive Behavioral Therapy (CBT) on Weight Maintenance After Successful Weight Loss
A study testing CBT + Hypo-energetic Diet and Hypo-energetic Diet only in people with Obesity and Overweight, run by Novindiet Clinic at 1 site in Iran.
Trial summary
The purpose of this study is to assess the effects of CBT after a successful weight loss by a comprehensive weight loss plan on weight maintenance in obese female adults. 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?
- CBT + Hypo-energetic Diet and Hypo-energetic Diet only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Feb 2015to May 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
- Body mass index (BMI) between 23-30 kg/ m² who lost at least 10% of her initial weight by the diet plan.
- Must be able to have moderate exercise.
- Must be interested to keep weight loss.
Who cannot join
- Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
- Taking medications 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
Official title: Effects of Cognitive Behavioral Therapy After a Successful Weight Loss by a Comprehensive Weight Loss Plan (NovinDiet Plan) on Weight Maintenance in Healthy Obese Female Adults: a Randomized Clinical Trial
The purpose of this study is to assess the effects of CBT after a successful weight loss by a comprehensive weight loss plan on weight maintenance in obese female adults.
- Conditions
- Obesity, Overweight
- Being tested
- CBT + Hypo-energetic Diet, Hypo-energetic Diet only
- Keywords
- weight maintenance, cognitive behavior therapy, successful weight loss
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT + Hypo-energetic DietBehavioural
This group will have cognitive behavioral therapy classes + follow the hypo-energetic diet after losing at least 10% of their body weight by using a weight loss program. They will also have monthly follow-up to 6 months by fortnightly dietician visit.
Hypo-energetic Diet onlyBehavioural
This group will receive the hypo-energetic diet only after losing at least 10% of their body weight by using a weight loss program. They will also have monthly follow-up to 6 months by fortnightly dietician visit.
| Study group | Role | What they receive |
|---|---|---|
| CBT + Hypo-energetic Diet | Experimental | Not described Receives: Behavioral: CBT + Hypo-energetic Diet |
| Hypo-energetic Diet only | Experimental | Not described Receives: Behavioral: Hypo-energetic Diet only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 24 Weeks
Secondary outcomes (5)
Fasting plasma glucose level
Measured: 24 weeks
lipid profiles
Measured: 48 weeks
Insulin resistance(HOMA)
Measured: 24 weeks
Waist circumference
Measured: 24 Weeks
Body mass index reduction
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 posted25 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novindiet Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Tehran University of Medical Sciences, University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Hamid R Farshchi, MD, PhD, Study chair, NovinDiet Clinic, School of Life Sciences, The University of NottinghamAmeneh Madjd, Dr., Principal investigator, NovinDiet Clinic, School of Life Sciences, The University of NottinghamIan A Macdonald, Prof., Principal investigator, School of Life Sciences, The University of NottinghamMoira A Taylor, PhD, Principal investigator, School of Life Sciences, The University of NottinghamReza Malekzadeh, Prof., Principal investigator, Digestive Disease Research Institute, Tehran University of Medical SciencesAlireza Delavari, MD, Principal investigator, Digestive Disease Research Institute, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398253
- Sponsor's protocol ID
- ND-105
- Status last verified
- Oct 2019
- First submitted
- 20 Mar 2015
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Behavioral Therapy After a Successful Weight Loss by a Comprehensive Weight Loss Plan (NovinDiet Plan) on Weight Maintenance in Healthy Obese Female Adults: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02398253
- Acronym / sponsor ID
- ND-105
- Conditions
- Obesity, Overweight
- Keywords
- weight maintenance, cognitive behavior therapy, successful weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Novindiet ClinicUniversity, hospital or other
- Collaborators
- Tehran University of Medical Sciences, University of Nottingham
- Study start
- Feb 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 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 study is to assess the effects of CBT after a successful weight loss by a comprehensive weight loss plan on weight maintenance in obese female adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT + Hypo-energetic Diet | Experimental | Behavioral: CBT + Hypo-energetic Diet |
| Hypo-energetic Diet only | Experimental | Behavioral: Hypo-energetic Diet only |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) between 23-30 kg/ m² who lost at least 10% of her initial weight by the diet plan.
- Must be able to have moderate exercise.
- Must be interested to keep weight loss.
Key exclusion criteria (6 listed)
- Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
- Taking medications that could affect metabolism or change body weight.
- Report heart problems, chest pain, and cancer within the last five years.
- Smoking
- Menopause
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 |
|---|---|---|
| CBT + Hypo-energetic DietThis group will have cognitive behavioral therapy classes + follow the hypo-energetic diet after losing at least 10% of their body weight by using a weight loss program. They will also have monthly follow-up to 6 months by fortnightly dietician visit. | Behavioural | CBT + Hypo-energetic Diet |
| Hypo-energetic Diet onlyThis group will receive the hypo-energetic diet only after losing at least 10% of their body weight by using a weight loss program. They will also have monthly follow-up to 6 months by fortnightly dietician visit. | Behavioural | Hypo-energetic Diet only |
Primary outcome
Weight loss
Time frame: 24 Weeks
5 secondary outcomes
Fasting plasma glucose level
Time frame: 24 weeks
lipid profiles
Time frame: 48 weeks
Insulin resistance(HOMA)
Time frame: 24 weeks
Waist circumference
Time frame: 24 Weeks
Body mass index reduction
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 25 Oct 2019.
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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.
Hamid R Farshchi, MD, PhD study chair
NovinDiet Clinic, School of Life Sciences, The University of Nottingham
Ameneh Madjd, Dr. principal investigator
NovinDiet Clinic, School of Life Sciences, The University of Nottingham
Ian A Macdonald, Prof. principal investigator
School of Life Sciences, The University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT + Hypo-energetic Diet and Hypo-energetic Diet only 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 3 inclusion and 6 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 25 Oct 2019. 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). 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 25 Oct 2019.