Obesity, AdolescentNCT02180802
Parental Involvement Improves the Effect of Motivational Interviewing on Weight Loss in Obese Adolescents: A Randomized Controlled Trial Study
A study testing motivational interviewing and motivational interviewing with parental involvement in people with Obesity, Adolescent, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial summary
Motivational interviewing (MI) has been shown to be an effective strategy in targeting obesity in adolescents and parental involvement has been associated with increased effectiveness. The aim of the study is to evaluate and compare the role of parental involvement in MI interventions for obese adolescents Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Obesity, Adolescent
- What is being tested?
- motivational interviewing and motivational interviewing with parental involvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteIran
- Study dates
- Feb 2011to Apr 2013
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- BMI equal or higher than 95th percentile for age and gender
- 13-18 years old
Who cannot join
- medication with weight gain as side effects
- diagnosed with having eating disorder
- pregnant
- clinical mental health conditions
- psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Motivational interviewing (MI) has been shown to be an effective strategy in targeting obesity in adolescents and parental involvement has been associated with increased effectiveness. The aim of the study is to evaluate and compare the role of parental involvement in MI interventions for obese adolescents
- Conditions
- Obesity, Adolescent
- Being tested
- motivational interviewing, motivational interviewing with parental involvement, Control group
- Keywords
- obese adolescents, BMI ≥ 95th percentile for age and gender
- Medical subject headings
- Pediatric Obesity, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewingBehavioural
motivational interviewing with parental involvementBehavioural
Control groupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| motivational intervieing group | Experimental | The behavioral intervention targets were improved eating and physical activity behavior in order to reduce obesity levels. Each adolescent was encouraged to eat a variety of foods from each of the four major food groups and low-fat alternatives . Moreover, each adolescent was encouraged to achieve at least 60 minutes of moderate-to-vigorous intensity physical activity daily as recommended by the World Health Organization Receives: Behavioral: motivational interviewing |
| motivational interviewi group with parental involvement | Experimental | an additional single session with parents or guardians over 60 minutes in the clinic Receives: Behavioral: motivational interviewing with parental involvement |
| Control | Active comparator | The patients received routine care Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in BMI
Body Mass Index
Measured: changes from baseline and 12 months follow-up
Child Dietary Self-Efficacy
Child Dietary Self-Efficacy Scale (CDSS)
Measured: changes from baseline and 12 months follow-up
Weight Efficacy Lifestyle
Weight Efficacy Lifestyle questionnaire (WEL)
Measured: changes from baseline and 12 months follow-up
Physical Exercise Self-efficacy
Physical Exercise Self-efficacy Scale (PES)
Measured: changes from baseline and 12 months follow-up
changes in physical activity
Measured: changes from baseline and 12 months follow-up
changes in dietary pattern
Measured: changes from baseline and 12 months follow-up
Secondary outcomes (3)
Changes in blood cholesterol level
Measured: changes from baseline and 12 months follow-up
changes in blood triglyceride level
Measured: changes from baseline and 12 months follow-up
Changes in body fat percentage
Measured: changes from baseline and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startFeb 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AdolescentStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180802
- Sponsor's protocol ID
- 3287
- Status last verified
- Aug 2014
- First submitted
- 1 Jul 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Involvement Improves the Effect of Motivational Interviewing on Weight Loss in Obese Adolescents: A Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT02180802
- Acronym / sponsor ID
- 3287
- Conditions
- Obesity, Adolescent
- Keywords
- obese adolescents, BMI ≥ 95th percentile for age and gender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Jul 2014 (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.
Motivational interviewing (MI) has been shown to be an effective strategy in targeting obesity in adolescents and parental involvement has been associated with increased effectiveness. The aim of the study is to evaluate and compare the role of parental involvement in MI interventions for obese adolescents
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| motivational intervieing group | Experimental | Behavioral: motivational interviewingThe behavioral intervention targets were improved eating and physical activity behavior in order to reduce obesity levels. Each adolescent was encouraged to eat a variety of foods from each of the four major food groups and low-fat alternatives . Moreover, each adolescent was encouraged to achieve at least 60 minutes of moderate-to-vigorous intensity physical activity daily as recommended by the World Health Organization |
| motivational interviewi group with parental involvement | Experimental | Behavioral: motivational interviewing with parental involvementan additional single session with parents or guardians over 60 minutes in the clinic |
| Control | Active comparator | Behavioral: Control groupThe patients received routine care |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- BMI equal or higher than 95th percentile for age and gender
- 13-18 years old
Key exclusion criteria (5 listed)
- medication with weight gain as side effects
- diagnosed with having eating disorder
- pregnant
- clinical mental health conditions
- psychosis
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 |
|---|---|---|
| motivational interviewing | Behavioural | motivational intervieing group |
| motivational interviewing with parental involvement | Behavioural | motivational interviewi group with parental involvement |
| Control group | Behavioural | Control |
Primary outcome
changes in BMI
Time frame: changes from baseline and 12 months follow-up
Body Mass Index
Child Dietary Self-Efficacy
Time frame: changes from baseline and 12 months follow-up
Child Dietary Self-Efficacy Scale (CDSS)
Weight Efficacy Lifestyle
Time frame: changes from baseline and 12 months follow-up
Weight Efficacy Lifestyle questionnaire (WEL)
Physical Exercise Self-efficacy
Time frame: changes from baseline and 12 months follow-up
Physical Exercise Self-efficacy Scale (PES)
changes in physical activity
Time frame: changes from baseline and 12 months follow-up
changes in dietary pattern
Time frame: changes from baseline and 12 months follow-up
3 secondary outcomes
Changes in blood cholesterol level
Time frame: changes from baseline and 12 months follow-up
changes in blood triglyceride level
Time frame: changes from baseline and 12 months follow-up
Changes in body fat percentage
Time frame: changes from baseline and 12 months follow-up
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 3 Sep 2014.
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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 motivational interviewing and motivational interviewing with parental involvement in people with Obesity, Adolescent, run by Qazvin University Of Medical Sciences 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 2 inclusion and 5 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 3 Sep 2014. 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?
changes in BMI (time frame: changes from baseline and 12 months follow-up). The study lists 6 primary outcomes in all. 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 3 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.