Quality of LifeNCT02901457
"The Healthy Body Image" (HBI) Program: A Program to Promote a Positive Body Image
A study testing The "Healthy Body Image" intervention in people with Quality of Life and Eating Behaviors, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial summary
Too many Norwegian adolescents experience severe body dissatisfaction (40-70 %), and strive to accomplish the "perfect body". At the same time, only 50 % meet the government's recommendations on physical activity and intake of fruits and vegetables. Also, 14-24 % has unhealthy sleeping habits. Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Eating Behaviors, Physical Activity
- What is being tested?
- The "Healthy Body Image" intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,193 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2016to Feb 2018
- 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 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Norwegian high schools
- High schools located in either Oslo or Akershus County
- Students in the 2nd grade fall 2016
- Students within academic specialization education programs
- Teachers teaching included students in Norwegian, Social studies, Physical education, and contact teachers
- School nurses working at the randomly selected schools
- School administrators at randomly selected schools
Who cannot join
- Schools that follow foreign school systems
- Students within vocational education programs
- School departments connected to prison
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "The Healthy Body Image" (HBI) Program: A Program to Promote a Positive Body Image. A School-based Randomized Controlled Trial
Too many Norwegian adolescents experience severe body dissatisfaction (40-70 %), and strive to accomplish the "perfect body". At the same time, only 50 % meet the government's recommendations on physical activity and intake of fruits and vegetables. Also, 14-24 % has unhealthy sleeping habits. Optimizing these lifestyle factors is associated with physical and psychological health. These factors, along with the pressure to obtain the "perfect" body, are threatening the adolescent's physical and psychological health, jfr. Meld St nr 19. It is now a need for knowledge on how the investigators can contribute to promote positive body experience among the adolescents.
It has recently, through a controlled study on elite youth athletes at Norwegian sports high schools, been shown that it is possible to change eating habits, improve body image and reduce new cases of eating disorder. It is now desirable to test an adapted program through a school-based program at regular Norwegian high school students (12th grade). Today, no controlled, school-based intervention studies with long-term follow-up have been conducted.
Read more
The main aim of this project is to investigate if it is possible, through a school-based intervention program (Healthy Body Intervention), to promote positive body image, increase physical activity level, and healthy eating and sleeping habits in both boys and girls at Norwegian high schools.
The intervention program will contribute with new evidence-based knowledge on the effect of an adapted health-promoting program.
Read the detailed description
The design is a school-based randomized controlled trial (RCT) intervention, using the methods questionnaire and interview to obtain data. Based on statistical power analyses, all high schools in Oslo and Akershus County will be asked to participate in the study. After the schools have responded, consenting schools will be stratified (by size and geographical affiliation) and randomized to the intervention or the control condition. To minimize contamination biases within schools, the investigators prepare a cluster-randomized design.The population should contain 17-20 schools (1400 students at 2nd year). Data collection is conducted through pre-test and post-test 1, 2, and 3 (acute, 3, and 12 month post-intervention). At post-test 1, a selection is invited to participate in an interview about feasibility in addition to the questionnaire. It is an intervention for students containing interactive lecturers with discussion, team work, discussions and home assignments.
- Conditions
- Quality of Life, Eating Behaviors, Physical Activity
- Being tested
- The "Healthy Body Image" intervention
- Keywords
- Body Image
- Medical subject headings
- Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The "Healthy Body Image" interventionOther
Also called Healthy Body Image
Interactive workshops (3 x 90 minutes) include training techniques to increase media literacy, enhance self-esteem, positive body image, awareness of perfectionism, and include discussions related to truths and myths related to life style factors. Homework is an extension of each workshop that is simple and not time-consuming tasks to increase reflection and awareness of how all the mentioned factors are a part of their lives.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Body Image | Experimental | Students receive the Healthy Body Image intervention containing 3x90 minutes of interactive workshops with the addition of related homework after each workshop. Receives: Other: The "Healthy Body Image" intervention |
| Control group | No intervention | Students do not receive the intervention program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal and distal effect of the "Healthy Body Intervention" (HBI) program on change in positive body image
Participants are asked to respond to questions by choosing from different responses presented on a likert scale. Positive body image is assessed by the Experience of Embodiment Scale.
Measured: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention
Secondary outcomes (8)
Proximal and distal effect of the HBI program on change in self-esteem
Participants are asked to respond to questions by choosing from different responses presented on a likert scale. The scale used is the Rosenberg Self-esteem scale.
Measured: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention
Proximal and distal effect of the "Healthy Body Intervention" (HBI) program on change in the prevalence of students meeting the recommendations for health promoting physical activity.
The outcome will be measured through a self-developed Physical Activity level/habit questionnaire, including choosing a specific response on a likert scale and response through open ended questions.
Measured: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention
Experience of the intervention program and the feasibility of running the HBI program in schools.
To measure the outcome, a self-developed interview guide in addition to a self-developed questionnaire asking students and school staff about the experience of the intervention program and the feasibility of the intervention. When answering the questionnaire, participants are asked to respond by choosing a response on a likert scale.
Measured: Post-test is planned within first week after intervention
Proximal and distal effect of the HBI program on change in eating behavior (nutrition intake
The outcome will be measured through a self-developed Food frequency questionnaire where responses are chosen from a likert scale.
Measured: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention
Proximal and distal effect of the HBI program on change in sleeping quality and sleep patterns
The outcome is measured through The Bergen Insomnia Scale, 6 items and 3 items assessing delayed sleep phase and by asking the participants (using a likert scale) how many hours of sleep they usually get per night during a normal weekday and a weekend day.
Measured: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention
Proximal and distal effect of the HBI program on change in academic achievements
Participants are asked to choose the correct grade they received on their last report card, from a scale presenting the possible grades.
Measured: Participants are asked to complete the questions included in the questionnaire package at post-tests planned at week 1, 3 months and 12 months after intervention
Proximal and distal effect of the "Healthy Body Intervention" (HBI) program on change in health related quality of life
Participants are asked to respond to questions by choosing from different responses presented on a likert scale. Health related quality of life will be assessed through the "Screening for and Promotion of Health Related Quality of Life in Children an Adolescents - a European Public Health Perspective - 10" (KIDSKREEN-10).
Measured: Participants are asked to complete the questionnaire containing all the below presented measures at post-tests planned at week 1, 3 months and 12 months after intervention
Proximal and distal effect of the HBI program on change in symptoms of eating disorders
Symptoms of eating disorders is assessed by the Eating Disorder Examination Questionnaire - 11 (EDE-Q 11)
Measured: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Women´s Public Health Association, Norwegian Extra Foundation for Health and Rehabilitation, University of Tromso, University College of Southeast Norway, University of Agder
- Responsible party
- Principal investigator, Professor Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences
- Investigators
- Jorunn Sundgot-Borgen, Phd, Study chair, Norwegain School of Sports Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901457
- Sponsor's protocol ID
- JCSB
- Status last verified
- Aug 2021
- First submitted
- 24 Apr 2016
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Strand BH, Dalgard OS, Tambs K, Rognerud M. Measuring the mental health status of the Norwegian population: a comparison of the instruments SCL-25, SCL-10, SCL-5 and MHI-5 (SF-36). Nord J Psychiatry. 2003;57(2):113-8. doi: 10.1080/08039480310000932.
PubMed 12745773Andersen JR, Natvig GK, Haraldstad K, Skrede T, Aadland E, Resaland GK. Psychometric properties of the Norwegian version of the Kidscreen-27 questionnaire. Health Qual Life Outcomes. 2016 Apr 9;14:58. doi: 10.1186/s12955-016-0460-4.
PubMed 27062022Rosenberg M. Society and the Adolescent Self-Image. Princeton, NJ: Princeton University Press; 1965.
Pallesen S, Hetland J, Sivertsen B, Samdal O, Torsheim T, Nordhus IH. Time trends in sleep-onset difficulties among Norwegian adolescents: 1983--2005. Scand J Public Health. 2008 Nov;36(8):889-95. doi: 10.1177/1403494808095953.
PubMed 19004908Schaefer LM, Burke NL, Thompson JK, Dedrick RF, Heinberg LJ, Calogero RM, Bardone-Cone AM, Higgins MK, Frederick DA, Kelly M, Anderson DA, Schaumberg K, Nerini A, Stefanile C, Dittmar H, Clark E, Adams Z, Macwana S, Klump KL, Vercellone AC, Paxton SJ, Swami V. Development and validation of the Sociocultural Attitudes Towards Appearance Questionnaire-4 (SATAQ-4). Psychol Assess. 2015 Mar;27(1):54-67. doi: 10.1037/a0037917. Epub 2014 Oct 6.
PubMed 25285718Friborg O, Reas DL, Rosenvinge JH, Ro O. Core pathology of eating disorders as measured by the Eating Disorder Examination Questionnaire (EDE-Q): the predictive role of a nested general (g) and primary factors. Int J Methods Psychiatr Res. 2013 Sep;22(3):195-203. doi: 10.1002/mpr.1389. Epub 2013 Aug 19.
PubMed 24038315Sandoz EK, Wilson, K.G., Merwin, R.M., Kellum, K.K. Assessment of body imageflexibility: The Body Image-Acceptance and Action Questionnaire. Journal of Contextual Behavioral Science. 2013:39-48
Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
PubMed 21584907Smolak L, Murnen SK. Drive for leanness: assessment and relationship to gender, gender role and objectification. Body Image. 2008 Sep;5(3):251-60. doi: 10.1016/j.bodyim.2008.03.004. Epub 2008 Jun 26.
PubMed 18585105Smolak L, & Piran, N. . Gender and the prevention of eating disorders. In: G. McVey MPL, N. Piran & H. B. Ferguson editor. Preventing eating-related and weight-related disorders: Collaborative research, advocacy, and policy change. Waterloo, ON: Wilfred Laurier Press; 2012. p. 201-24.
Sundgot-Borgen C, Friborg O, Kolle E, Torstveit MK, Sundgot-Borgen J, Engen KME, Rosenvinge JH, Pettersen G, Bratland-Sanda S. Does the Healthy Body Image program improve lifestyle habits among high school students? A randomized controlled trial with 12-month follow-up. J Int Med Res. 2020 Mar;48(3):300060519889453. doi: 10.1177/0300060519889453. Epub 2019 Dec 5.
PubMed 31802697Sundgot-Borgen C, Bratland-Sanda S, Engen KME, Pettersen G, Friborg O, Torstveit MK, Kolle E, Piran N, Sundgot-Borgen J, Rosenvinge JH. The Norwegian healthy body image programme: study protocol for a randomized controlled school-based intervention to promote positive body image and prevent disordered eating among Norwegian high school students. BMC Psychol. 2018 Mar 6;6(1):8. doi: 10.1186/s40359-018-0221-8.
PubMed 29510762
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Healthy Body Image" (HBI) Program: A Program to Promote a Positive Body Image. A School-based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02901457
- Acronym / sponsor ID
- JCSB
- Conditions
- Quality of Life, Eating Behaviors, Physical Activity
- Keywords
- Body Image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,193 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- The Norwegian Women´s Public Health Association, Norwegian Extra Foundation for Health and Rehabilitation, University of Tromso, University College of Southeast Norway, University of Agder
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 15 Sep 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.
Too many Norwegian adolescents experience severe body dissatisfaction (40-70 %), and strive to accomplish the "perfect body". At the same time, only 50 % meet the government's recommendations on physical activity and intake of fruits and vegetables. Also, 14-24 % has unhealthy sleeping habits. Optimizing these lifestyle factors is associated with physical and psychological health. These factors, along with the pressure to obtain the "perfect" body, are threatening the adolescent's physical and psychological health, jfr. Meld St nr 19. It is now a need for knowledge on how the investigators can contribute to promote positive body experience among the adolescents.
It has recently, through a controlled study on elite youth athletes at Norwegian sports high schools, been shown that it is possible to change eating habits, improve body image and reduce new cases of eating disorder. It is now desirable to test an adapted program through a school-based program at regular Norwegian high school students (12th grade). Today, no controlled, school-based intervention studies with long-term follow-up have been conducted.
The main aim of this project is to investigate if it is possible, through a school-based intervention program (Healthy Body Intervention), to promote positive body image, increase physical activity level, and healthy eating and sleeping habits in both boys and girls at Norwegian high schools.
The intervention program will contribute with new evidence-based knowledge on the effect of an adapted health-promoting program.
Detailed description
The design is a school-based randomized controlled trial (RCT) intervention, using the methods questionnaire and interview to obtain data. Based on statistical power analyses, all high schools in Oslo and Akershus County will be asked to participate in the study. After the schools have responded, consenting schools will be stratified (by size and geographical affiliation) and randomized to the intervention or the control condition. To minimize contamination biases within schools, the investigators prepare a cluster-randomized design.The population should contain 17-20 schools (1400 students at 2nd year). Data collection is conducted through pre-test and post-test 1, 2, and 3 (acute, 3, and 12 month post-intervention). At post-test 1, a selection is invited to participate in an interview about feasibility in addition to the questionnaire. It is an intervention for students containing interactive lecturers with discussion, team work, discussions and home assignments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Body Image | Experimental | Other: The "Healthy Body Image" interventionStudents receive the Healthy Body Image intervention containing 3x90 minutes of interactive workshops with the addition of related homework after each workshop. |
| Control group | No intervention | –Students do not receive the intervention program. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Norwegian high schools
- High schools located in either Oslo or Akershus County
- Students in the 2nd grade fall 2016
- Students within academic specialization education programs
- Teachers teaching included students in Norwegian, Social studies, Physical education, and contact teachers
Key exclusion criteria (3 listed)
- Schools that follow foreign school systems
- Students within vocational education programs
- School departments connected to prison
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 |
|---|---|---|
| The "Healthy Body Image" interventionAlso: Healthy Body ImageInteractive workshops (3 x 90 minutes) include training techniques to increase media literacy, enhance self-esteem, positive body image, awareness of perfectionism, and include discussions related to truths and myths related to life style factors. Homework is an extension of each workshop that is simple and not time-consuming tasks to increase reflection and awareness of how all the mentioned factors are a part of their lives. | Other | Healthy Body Image |
Primary outcome
Proximal and distal effect of the "Healthy Body Intervention" (HBI) program on change in positive body image
Time frame: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention
Participants are asked to respond to questions by choosing from different responses presented on a likert scale. Positive body image is assessed by the Experience of Embodiment Scale.
8 secondary outcomes
Proximal and distal effect of the HBI program on change in self-esteem
Time frame: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention
Proximal and distal effect of the "Healthy Body Intervention" (HBI) program on change in the prevalence of students meeting the recommendations for health promoting physical activity.
Time frame: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention
Experience of the intervention program and the feasibility of running the HBI program in schools.
Time frame: Post-test is planned within first week after intervention
Proximal and distal effect of the HBI program on change in eating behavior (nutrition intake
Time frame: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention
Proximal and distal effect of the HBI program on change in sleeping quality and sleep patterns
Time frame: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention
Proximal and distal effect of the HBI program on change in academic achievements
Time frame: Participants are asked to complete the questions included in the questionnaire package at post-tests planned at week 1, 3 months and 12 months after intervention
Proximal and distal effect of the "Healthy Body Intervention" (HBI) program on change in health related quality of life
Time frame: Participants are asked to complete the questionnaire containing all the below presented measures at post-tests planned at week 1, 3 months and 12 months after intervention
Proximal and distal effect of the HBI program on change in symptoms of eating disorders
Time frame: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention
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 21 Mar 2024.
- Background: PubMed 12745773Strand BH, Dalgard OS, Tambs K, Rognerud M. Measuring the mental health status of the Norwegian population: a comparison of the instruments SCL-25, SCL-10, SCL-5 and MHI-5 (SF-36). Nord J Psychiatry. 2003;57(2):113-8. doi: 10.1080/08039480310000932.
- Background: PubMed 27062022Andersen JR, Natvig GK, Haraldstad K, Skrede T, Aadland E, Resaland GK. Psychometric properties of the Norwegian version of the Kidscreen-27 questionnaire. Health Qual Life Outcomes. 2016 Apr 9;14:58. doi: 10.1186/s12955-016-0460-4.
- BackgroundRosenberg M. Society and the Adolescent Self-Image. Princeton, NJ: Princeton University Press; 1965.
- Background: PubMed 19004908Pallesen S, Hetland J, Sivertsen B, Samdal O, Torsheim T, Nordhus IH. Time trends in sleep-onset difficulties among Norwegian adolescents: 1983--2005. Scand J Public Health. 2008 Nov;36(8):889-95. doi: 10.1177/1403494808095953.
- Background: PubMed 25285718Schaefer LM, Burke NL, Thompson JK, Dedrick RF, Heinberg LJ, Calogero RM, Bardone-Cone AM, Higgins MK, Frederick DA, Kelly M, Anderson DA, Schaumberg K, Nerini A, Stefanile C, Dittmar H, Clark E, Adams Z, Macwana S, Klump KL, Vercellone AC, Paxton SJ, Swami V. Development and validation of the Sociocultural Attitudes Towards Appearance Questionnaire-4 (SATAQ-4). Psychol Assess. 2015 Mar;27(1):54-67. doi: 10.1037/a0037917. Epub 2014 Oct 6.
- Background: PubMed 24038315Friborg O, Reas DL, Rosenvinge JH, Ro O. Core pathology of eating disorders as measured by the Eating Disorder Examination Questionnaire (EDE-Q): the predictive role of a nested general (g) and primary factors. Int J Methods Psychiatr Res. 2013 Sep;22(3):195-203. doi: 10.1002/mpr.1389. Epub 2013 Aug 19.
- BackgroundSandoz EK, Wilson, K.G., Merwin, R.M., Kellum, K.K. Assessment of body imageflexibility: The Body Image-Acceptance and Action Questionnaire. Journal of Contextual Behavioral Science. 2013:39-48
- Background: PubMed 21584907Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
- Background: PubMed 18585105Smolak L, Murnen SK. Drive for leanness: assessment and relationship to gender, gender role and objectification. Body Image. 2008 Sep;5(3):251-60. doi: 10.1016/j.bodyim.2008.03.004. Epub 2008 Jun 26.
- BackgroundSmolak L, & Piran, N. . Gender and the prevention of eating disorders. In: G. McVey MPL, N. Piran & H. B. Ferguson editor. Preventing eating-related and weight-related disorders: Collaborative research, advocacy, and policy change. Waterloo, ON: Wilfred Laurier Press; 2012. p. 201-24.
- Derived from this study: PubMed 31802697Sundgot-Borgen C, Friborg O, Kolle E, Torstveit MK, Sundgot-Borgen J, Engen KME, Rosenvinge JH, Pettersen G, Bratland-Sanda S. Does the Healthy Body Image program improve lifestyle habits among high school students? A randomized controlled trial with 12-month follow-up. J Int Med Res. 2020 Mar;48(3):300060519889453. doi: 10.1177/0300060519889453. Epub 2019 Dec 5.
- Derived from this study: PubMed 29510762Sundgot-Borgen C, Bratland-Sanda S, Engen KME, Pettersen G, Friborg O, Torstveit MK, Kolle E, Piran N, Sundgot-Borgen J, Rosenvinge JH. The Norwegian healthy body image programme: study protocol for a randomized controlled school-based intervention to promote positive body image and prevent disordered eating among Norwegian high school students. BMC Psychol. 2018 Mar 6;6(1):8. doi: 10.1186/s40359-018-0221-8.
- 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.
Jorunn Sundgot-Borgen, Phd study chair
Norwegain School of Sports Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The "Healthy Body Image" intervention in people with Quality of Life and Eating Behaviors, run by Norwegian School of Sport Sciences at 1 site in Norway.
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 7 inclusion and 3 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 21 Mar 2024. 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 Norway. 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?
Proximal and distal effect of the "Healthy Body Intervention" (HBI) program on change in positive body image (time frame: Participants are asked to complete the questionnaire at post-tests planned at week 1, 3 months and 12 months after intervention). 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 NCT02901457, which also lists 12 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 21 Mar 2024.