ObesityIMAGINENCT02745795
Efficacy of Motivational Interview in the Treatment of Obesity and Overweight in Adolescents
A study testing Motivational Interview and Conventional Interview in people with Obesity, run by Centro Hospitalar Lisboa Norte.
Trial summary
The objective of the study is to investigate the efficacy of motivational interview intervention with adolescent students at a school environment on the adhesion to a therapeutic plan to loose weight. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Motivational Interview and Conventional Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Oct 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 14 and 19 years old
- Body mass index percentile equal or above 85th percentile according to World Health Organization charts (de Onis 2010)
Who cannot join
- recent weight loss of 10% or more of body weight
- pregnancy
- breastfeeding
- endocrine disease
- present therapy with antidepressant or hypoglycemic drugs
- present treatment for food behavior disease or depression
- cognitive impairment of the student or his/her legal tutor.
About this study
Official title: Motivational Intervention Through the Generation of an Interpersonal Plan About Nutrition and Physical Exercise Study (IMAGINE Study), a Randomized Controlled Trial With Obese and Overweight Adolescents in Portuguese High Schools
The objective of the study is to investigate the efficacy of motivational interview intervention with adolescent students at a school environment on the adhesion to a therapeutic plan to loose weight.
Read the detailed description
Motivational interview (MI) is a style of communication collaborative, objective-directed, with special attention to change talk.
The present study's main objective is to investigate the efficacy of a MI intervention in adolescents with weight excess, in a school setting, over their motivation to adhere to a health lifestyle plan of dietary habits and physical exercise.
Secondary objectives are to investigate the effect of MI over self-concept, quality of life, depressive symptoms, anxiety symptoms, body mass index, abdominal circumference and blood pressure.
Registry Procedures Data on anthropometric parameters is recorded in data collection sheet and stored in individual files, which are available for monitoring procedures and for auditing by the Metabolic and Food Behavior Disorders Scientific Committee.
Data Checks Data checks will be performed to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry
Source Data Verification All the data will be checked to assess accuracy, completeness, or representativeness of registry data by comparing the data to external data sources: audio-taped interviews, paper case report forms and paper case self-report forms. All the registries will be stored during five years after study completions according to the Medical Faculty of Lisbon norms.
Variables:
Motivational Interview Audio-taped clinical interview record Motivational Interviewing Treatment Integrity (MITI) version 3.1.1
Motivation to adhere to a physical exercise plan Self-report by a paper questionnaire Self-regulation and perceived competence questionnaire to begin or maintain an healthy diet
Motivation to adhere to a diet plan Self-report by a paper questionnaire Self-regulation and perceived competence questionnaire to begin or maintain regular physical exercise
Self-concept Self-report by a paper questionnaire Self Perception Profile for Children
Quality of life Self-report by a paper questionnaire Pediatric Quality of Life Inventory 4.0 (PEDSQL 4.0)
Depressive symptoms Self-report by a paper questionnaire Children Depression Inventory (CDI)
Anxiety symptoms Self-report by a paper questionnaire State-Trait Anxiety Inventory for Children (STAIC C-2)
Body mass index Calculated by the ratio of weight in kilograms over the square of height in meters^2.
Weight Direct measurement by the research team Measured with Omron Body Composition Monitor with Scale BF 11® (Omron®, Kyoto, Japan) in kilograms
Height Direct measurement by the research team Measured with Seca® 213 Portable Stadiometer Height-Rod® (Seca@, Hamburg, Germany) in meters
Abdominal circumference Direct measurement by the research team Seca 203 Circumference Measuring Tape® (Seca@, Hamburg, Germany) in centimeters
Blood pressure Direct measurement by the research team Riester Risan Sphygmomanometer® (Riester®, Jungingen, Germany) in mm Hg
- Conditions
- Obesity
- Being tested
- Motivational Interview, Conventional Interview
- Keywords
- Motivational interview, adolescents, obesity, overweight, physical activity, diet
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewBehavioural
Three face-to-face interviews using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.
Conventional InterviewBehavioural
Three face-to-face interviews without using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.
| Study group | Role | What they receive |
|---|---|---|
| MIG: Motivational Interview Group | Experimental | Group submitted to three face-to-face interviews using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals. Receives: Behavioral: Motivational Interview |
| CIG: Conventional Intervention Group | Sham comparator | Group submitted to three face-to-face interviews without using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals. Receives: Behavioral: Conventional Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation scores to adhere to a diet and physical activity plan
Motivation scores assessed by two self-report confidential paper questionnaires (Self-regulation and perceived competence questionnaire to begin or maintain an healthy diet and Self-regulation and perceived competence questionnaire to begin or maintain regular physical exercise)
Measured: Six months
Secondary outcomes (8)
Self-concept score
Self-report score assessed by a paper questionnaire (Self Perception Profile for Children)
Measured: Six months
Quality of life score
Quality of life score assessed by Pediatric Quality of Life Inventory 4.0 (PEDSQL 4.0)
Measured: Six months
Depressive symptoms score
Depressive symptoms score assessed by Children Depression Inventory (CDI)
Measured: Six months
Anxiety symptoms
Anxiety score symptoms assessed by State-Trait Anxiety Inventory for Children (STAIC C-2)
Measured: Six months
Abdominal circumference in centimeters
Abdominal circumference measured with Seca 203 Circumference Measuring Tape® (Seca@, Hamburg, Germany)
Measured: Six months
Blood pressure in mm Hg
Blood pressure measured with Riester Risan Sphygmomanometer® (Riester®, Jungingen, Germany)
Measured: Six months
Weight in kilograms
Weight measured with Omron Body Composition Monitor with Scale BF 11® (Omron®, Kyoto, Japan)
Measured: Six months
Height in meters
Height in meters measured with Seca® 213 Portable Stadiometer Height-Rod® (Seca@, Hamburg, Germany)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Lisboa Norte
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lisbon, Universidade do Porto
- Responsible party
- Principal investigator, Maria do Céu Machad, Centro Hospitalar Lisboa Norte
- Investigators
- Marina Serra-de-Lemos, PhD, Study chair, Faculty of Psychology and Education Sciences of University of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745795
- Sponsor's protocol ID
- CC-336
- Acronym
- IMAGINE
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Physical Activity Guidelines Advisory Committee report, 2008. To the Secretary of Health and Human Services. Part A: executive summary. Nutr Rev. 2009 Feb;67(2):114-20. doi: 10.1111/j.1753-4887.2008.00136.x. No abstract available.
PubMed 19178654Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.
PubMed 17716083Bean MK, Mazzeo SE, Stern M, Bowen D, Ingersoll K. A values-based Motivational Interviewing (MI) intervention for pediatric obesity: study design and methods for MI Values. Contemp Clin Trials. 2011 Sep;32(5):667-74. doi: 10.1016/j.cct.2011.04.010. Epub 2011 Apr 29.
PubMed 21554994Tanofsky-Kraff M, Shomaker LB, Wilfley DE, Young JF, Sbrocco T, Stephens M, Ranzenhofer LM, Elliott C, Brady S, Radin RM, Vannucci A, Bryant EJ, Osborn R, Berger SS, Olsen C, Kozlosky M, Reynolds JC, Yanovski JA. Targeted prevention of excess weight gain and eating disorders in high-risk adolescent girls: a randomized controlled trial. Am J Clin Nutr. 2014 Oct;100(4):1010-8. doi: 10.3945/ajcn.114.092536. Epub 2014 Aug 13.
PubMed 25240070de Onis M, Lobstein T. Defining obesity risk status in the general childhood population: which cut-offs should we use? Int J Pediatr Obes. 2010 Dec;5(6):458-60. doi: 10.3109/17477161003615583. Epub 2010 Mar 17. No abstract available.
PubMed 20233144Aviram A, Westra HA. The impact of motivational interviewing on resistance in cognitive behavioural therapy for generalized anxiety disorder. Psychother Res. 2011 Nov;21(6):698-708. doi: 10.1080/10503307.2011.610832. Epub 2011 Aug 31.
PubMed 21878034Kosti RI, Panagiotakos DB. The epidemic of obesity in children and adolescents in the world. Cent Eur J Public Health. 2006 Dec;14(4):151-9. doi: 10.21101/cejph.a3398.
PubMed 17243492Resnicow K, Jackson A, Wang T, De AK, McCarty F, Dudley WN, Baranowski T. A motivational interviewing intervention to increase fruit and vegetable intake through Black churches: results of the Eat for Life trial. Am J Public Health. 2001 Oct;91(10):1686-93. doi: 10.2105/ajph.91.10.1686.
PubMed 11574336Faria L. Harter's self-perception profile for children adapted for use with young Portuguese students. Percept Mot Skills. 2001 Jun;92(3 Pt 1):711-20. doi: 10.2466/pms.2001.92.3.711.
PubMed 11453198Gee S, Chin D, Ackerson L, Woo D, Howell A. Prevalence of childhood and adolescent overweight and obesity from 2003 to 2010 in an integrated health care delivery system. J Obes. 2013;2013:417907. doi: 10.1155/2013/417907. Epub 2013 Jul 18.
PubMed 23970960Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.
PubMed 4089116Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499Gidding SS, Dennison BA, Birch LL, Daniels SR, Gillman MW, Lichtenstein AH, Rattay KT, Steinberger J, Stettler N, Van Horn L; American Heart Association; American Academy of Pediatrics. Dietary recommendations for children and adolescents: a guide for practitioners: consensus statement from the American Heart Association. Circulation. 2005 Sep 27;112(13):2061-75. doi: 10.1161/CIRCULATIONAHA.105.169251.
PubMed 16186441Neumark-Sztainer DR, Friend SE, Flattum CF, Hannan PJ, Story MT, Bauer KW, Feldman SB, Petrich CA. New moves-preventing weight-related problems in adolescent girls a group-randomized study. Am J Prev Med. 2010 Nov;39(5):421-32. doi: 10.1016/j.amepre.2010.07.017.
PubMed 20965379Flattum C, Friend S, Story M, Neumark-Sztainer D. Evaluation of an individualized counseling approach as part of a multicomponent school-based program to prevent weight-related problems among adolescent girls. J Am Diet Assoc. 2011 Aug;111(8):1218-23. doi: 10.1016/j.jada.2011.05.008.
PubMed 21802570
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Intervention Through the Generation of an Interpersonal Plan About Nutrition and Physical Exercise Study (IMAGINE Study), a Randomized Controlled Trial With Obese and Overweight Adolescents in Portuguese High Schools
- ClinicalTrials.gov ID
- NCT02745795
- Acronym / sponsor ID
- IMAGINE / CC-336
- Conditions
- Obesity
- Keywords
- Motivational interview, adolescents, obesity, overweight, physical activity, diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Centro Hospitalar Lisboa NorteUniversity, hospital or other
- Collaborators
- University of Lisbon, Universidade do Porto
- Study start
- Oct 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 20 Apr 2016 (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 objective of the study is to investigate the efficacy of motivational interview intervention with adolescent students at a school environment on the adhesion to a therapeutic plan to loose weight.
Detailed description
Motivational interview (MI) is a style of communication collaborative, objective-directed, with special attention to change talk.
The present study's main objective is to investigate the efficacy of a MI intervention in adolescents with weight excess, in a school setting, over their motivation to adhere to a health lifestyle plan of dietary habits and physical exercise.
Secondary objectives are to investigate the effect of MI over self-concept, quality of life, depressive symptoms, anxiety symptoms, body mass index, abdominal circumference and blood pressure.
Registry Procedures Data on anthropometric parameters is recorded in data collection sheet and stored in individual files, which are available for monitoring procedures and for auditing by the Metabolic and Food Behavior Disorders Scientific Committee.
Data Checks Data checks will be performed to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry
Source Data Verification All the data will be checked to assess accuracy, completeness, or representativeness of registry data by comparing the data to external data sources: audio-taped interviews, paper case report forms and paper case self-report forms. All the registries will be stored during five years after study completions according to the Medical Faculty of Lisbon norms.
Variables:
Motivational Interview Audio-taped clinical interview record Motivational Interviewing Treatment Integrity (MITI) version 3.1.1
Motivation to adhere to a physical exercise plan Self-report by a paper questionnaire Self-regulation and perceived competence questionnaire to begin or maintain an healthy diet
Motivation to adhere to a diet plan Self-report by a paper questionnaire Self-regulation and perceived competence questionnaire to begin or maintain regular physical exercise
Self-concept Self-report by a paper questionnaire Self Perception Profile for Children
Quality of life Self-report by a paper questionnaire Pediatric Quality of Life Inventory 4.0 (PEDSQL 4.0)
Depressive symptoms Self-report by a paper questionnaire Children Depression Inventory (CDI)
Anxiety symptoms Self-report by a paper questionnaire State-Trait Anxiety Inventory for Children (STAIC C-2)
Body mass index Calculated by the ratio of weight in kilograms over the square of height in meters^2.
Weight Direct measurement by the research team Measured with Omron Body Composition Monitor with Scale BF 11® (Omron®, Kyoto, Japan) in kilograms
Height Direct measurement by the research team Measured with Seca® 213 Portable Stadiometer Height-Rod® (Seca@, Hamburg, Germany) in meters
Abdominal circumference Direct measurement by the research team Seca 203 Circumference Measuring Tape® (Seca@, Hamburg, Germany) in centimeters
Blood pressure Direct measurement by the research team Riester Risan Sphygmomanometer® (Riester®, Jungingen, Germany) in mm Hg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIG: Motivational Interview Group | Experimental | Behavioral: Motivational InterviewGroup submitted to three face-to-face interviews using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals. |
| CIG: Conventional Intervention Group | Sham comparator | Behavioral: Conventional InterviewGroup submitted to three face-to-face interviews without using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age between 14 and 19 years old
- Body mass index percentile equal or above 85th percentile according to World Health Organization charts (de Onis 2010)
Key exclusion criteria (7 listed)
- recent weight loss of 10% or more of body weight
- pregnancy
- breastfeeding
- endocrine disease
- present therapy with antidepressant or hypoglycemic drugs
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 InterviewThree face-to-face interviews using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals. | Behavioural | MIG: Motivational Interview Group |
| Conventional InterviewThree face-to-face interviews without using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals. | Behavioural | CIG: Conventional Intervention Group |
Primary outcome
Motivation scores to adhere to a diet and physical activity plan
Time frame: Six months
Motivation scores assessed by two self-report confidential paper questionnaires (Self-regulation and perceived competence questionnaire to begin or maintain an healthy diet and Self-regulation and perceived competence questionnaire to begin or maintain regular physical exercise)
8 secondary outcomes
Self-concept score
Time frame: Six months
Quality of life score
Time frame: Six months
Depressive symptoms score
Time frame: Six months
Anxiety symptoms
Time frame: Six months
Abdominal circumference in centimeters
Time frame: Six months
Blood pressure in mm Hg
Time frame: Six months
Weight in kilograms
Time frame: Six months
Height in meters
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Background: PubMed 19178654Physical Activity Guidelines Advisory Committee report, 2008. To the Secretary of Health and Human Services. Part A: executive summary. Nutr Rev. 2009 Feb;67(2):114-20. doi: 10.1111/j.1753-4887.2008.00136.x. No abstract available.
- Background: PubMed 17716083Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.
- Background: PubMed 21554994Bean MK, Mazzeo SE, Stern M, Bowen D, Ingersoll K. A values-based Motivational Interviewing (MI) intervention for pediatric obesity: study design and methods for MI Values. Contemp Clin Trials. 2011 Sep;32(5):667-74. doi: 10.1016/j.cct.2011.04.010. Epub 2011 Apr 29.
- Background: PubMed 25240070Tanofsky-Kraff M, Shomaker LB, Wilfley DE, Young JF, Sbrocco T, Stephens M, Ranzenhofer LM, Elliott C, Brady S, Radin RM, Vannucci A, Bryant EJ, Osborn R, Berger SS, Olsen C, Kozlosky M, Reynolds JC, Yanovski JA. Targeted prevention of excess weight gain and eating disorders in high-risk adolescent girls: a randomized controlled trial. Am J Clin Nutr. 2014 Oct;100(4):1010-8. doi: 10.3945/ajcn.114.092536. Epub 2014 Aug 13.
- Background: PubMed 20233144de Onis M, Lobstein T. Defining obesity risk status in the general childhood population: which cut-offs should we use? Int J Pediatr Obes. 2010 Dec;5(6):458-60. doi: 10.3109/17477161003615583. Epub 2010 Mar 17. No abstract available.
- Background: PubMed 21878034Aviram A, Westra HA. The impact of motivational interviewing on resistance in cognitive behavioural therapy for generalized anxiety disorder. Psychother Res. 2011 Nov;21(6):698-708. doi: 10.1080/10503307.2011.610832. Epub 2011 Aug 31.
- Background: PubMed 17243492Kosti RI, Panagiotakos DB. The epidemic of obesity in children and adolescents in the world. Cent Eur J Public Health. 2006 Dec;14(4):151-9. doi: 10.21101/cejph.a3398.
- Background: PubMed 11574336Resnicow K, Jackson A, Wang T, De AK, McCarty F, Dudley WN, Baranowski T. A motivational interviewing intervention to increase fruit and vegetable intake through Black churches: results of the Eat for Life trial. Am J Public Health. 2001 Oct;91(10):1686-93. doi: 10.2105/ajph.91.10.1686.
- Background: PubMed 11453198Faria L. Harter's self-perception profile for children adapted for use with young Portuguese students. Percept Mot Skills. 2001 Jun;92(3 Pt 1):711-20. doi: 10.2466/pms.2001.92.3.711.
- Background: PubMed 23970960Gee S, Chin D, Ackerson L, Woo D, Howell A. Prevalence of childhood and adolescent overweight and obesity from 2003 to 2010 in an integrated health care delivery system. J Obes. 2013;2013:417907. doi: 10.1155/2013/417907. Epub 2013 Jul 18.
- Background: PubMed 4089116Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.
- Background: PubMed 11468499Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
- Individual participant dataSharing planned: No
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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.
Marina Serra-de-Lemos, PhD study chair
Faculty of Psychology and Education Sciences of University of Porto
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interview and Conventional Interview in people with Obesity, run by Centro Hospitalar Lisboa Norte.
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 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: status not confirmed, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Motivation scores to adhere to a diet and physical activity plan (time frame: Six months). 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 NCT02745795, which also lists 30 linked publications.
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 20 Apr 2016.