Body ImageNCT04977973
Effectiveness of a Self-guided Mobile Phone Application in Improving the Way we See Ourselves and Our Bodies
A study testing Self-guided programme on body image and Self-guided programme on cooperation in people with Body Image, run by National University of Singapore at 1 site in Singapore.
Trial summary
Body image concerns are pervasive and can impact multiple aspects of a person's life. Individuals with negative body image tend to have negative thoughts and feelings about their bodies, often resulting in unhealthy behaviours. Negative body image is also associated with mental and physical health conditions. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Image
- What is being tested?
- Self-guided programme on body image and Self-guided programme on cooperation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Aug 2021to 10 Jan 2022
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-30
- good command of the English language
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Self-guided Body Image Program on a Mobile Application in Improving Body Image and Self-compassion in Young Adults
Body image concerns are pervasive and can impact multiple aspects of a person's life. Individuals with negative body image tend to have negative thoughts and feelings about their bodies, often resulting in unhealthy behaviours. Negative body image is also associated with mental and physical health conditions. Thus, prevention efforts are crucial to alleviating body image concerns in young adults as they are considered high-risk populations.
This study is a randomised controlled trial that aims to evaluate the effectiveness of a self-guided body image program on a mobile-based application for young adults.
Read more
Hypothesis 1a: The intervention group will improve significantly on measures of body image at post-intervention and follow-up, as compared to the control group.
Hypothesis 1b: The intervention group will reduce significantly on measures of appearance-ideal internalization, media and peer pressures at post-intervention and follow-up, as compared to the control group.
Hypothesis 2: The intervention group will improve significantly on the measure of self-compassion at post intervention and follow-up, as compared to the control group.
Read the detailed description
Procedure:
Participants will begin by reading the Participant Information Sheet (PIS) online. Once they have indicated consent on the online Consent Form, participants will proceed to complete a set of questionnaire on an online survey platform (Qualtrics) to obtain baseline ratings. The online questionnaire consists of four measures on body image, body image risk factors and self-compassion. Participants will also report demographic information such as gender and age.
Next, participants will download the phone application and be guided to navigate the application. The phone application for the programs in this study is provided by Intellect Pte Ltd, a Singaporean technology start-up company that collaborates with the supervisor of this project (OS). All participants will be randomized to one of two conditions- intervention or active wait-list control-using simple randomisation procedures. Participants in the intervention condition will participate in 9 days of body image program, while participants in the active wait-list control condition will participate in 9 days of cooperation learning program. In both programs, participants will engage in content learning and short activities daily on the phone application. The anticipated time participants will spend on each programs is comparable, of about less than five minutes per day.
Participants will be asked to complete the same set of online questionnaires immediately after completing the program (post-intervention measure), and four weeks after completing the program (follow-up measure). The feedback questionnaire will be administered only post-intervention. Participants will receive either course credit or a small monetary reimbursement after completing the program and questionnaire at post-intervention and at the four weeks follow-up.
At the end of the six weeks data collection period, all participants will be debriefed about the purpose of the study. Participants in the active wait-list control condition will be given access to the body image program.
Outcome Measures:
Body image measures:
Body Image Ideals Questionnaire (BIQ) is a 22-item scale that assesses body image satisfaction-dissatisfaction by measuring the degree of congruence or discrepancy of one's perceived and idealized physical attributes. On a scale from 0 (Exactly as I am) to 3 (Very unlike me), participants rate the degree they resemble their physical ideal on 11 physical attributes. Next, participants rate the importance that they attain their ideal on each physical attribute. The cross-products of the discrepancy and importance ratings for each physical attribute will be obtained and a composite BIQ score will be computed. Higher scores indicate a greater disparity between one's perceived and ideal physical attributes, suggesting higher levels of body dissatisfaction. BIQ has good internal consistency, with Cronbach's α of 0.81 for males and 0.76 for females.
Body Appreciation Scale-2 (BAS-2) is a 10-item scale that assesses individuals' positive attitudes toward their bodies. Items are scored on a scale from 1 (Never) to 5 (Always). Scores on all items are averaged with higher scores indicating greater body appreciation. BAS-2 has excellent internal consistency, with Cronbach's α of 0.96 for males and 0.97 for females.
Risk factor measures:
Sociocultural Attitudes Toward Appearance Questionnaire-4 Revised (SATAQ-4R) measures internalization ideals and appearance-related sociocultural pressures. The seven subscales consist of 31 items for females and 28 items for males on a scale from 1 (definitely disagree) to 5 (Definitely agree). Higher scores on each subscale indicate higher levels of internalisation and sociocultural pressures. The internal consistency of the subscales are good, with Cronbach's α of 0.82 or higher in a sample of university females and Cronbach's α of 0.75 or higher in a sample of university males.
Self-compassion measure:
Self-Compassion Scale-Short Form (SCS-SF) is a 12-item scale that measures self-compassion on six subscales. Each item is scored from 1 (Almost never) to 5 (Almost always). A total self-compassion score is a grand mean of all six subscale means, with higher scores indicating higher levels of self-compassion. The internal consistency of the scale is excellent, with Cronbach's α of 0.86.
Feedback questionnaire:
App Engagement Scale is a 7-item scale that measures participants' engagement on the phone application form 1 (Definitely disagree) to 5 (Definitely agree). A total score is derived by adding scores from each item. The internal reliability of the scale is good, with Cronbach's α of 0.84.
Power analysis and sample size:
Most studies that examined mobile and internet-based body image and eating disorder programs reported intervention effects of small to moderate effect sizes. Using G*power, a small effect size of Cohen's f = 0.1, and alpha = 0.05, an estimated sample size of 214 participants are required to achieve a power of at least 0.90. Taking into consideration a potential attrition rate of 30% in app-based interventions, 280 participants are required.
Statistical analyses:
Statistical analyses will be done using SPSS Version 26.0. All analysis will be conducted using two-tailed test with a level of significance at p < .05.
Data will first be visually inspected using scatterplots, histograms and boxplots to examine the distribution of data and identify significant outliers. Data further than three standard deviations from the mean will be identified as significant outliers. Further analyses will be conducted with and without the outliers to determine if outliers influence the results significantly. If outliers influence results significantly, they will be managed using the Winsorizing method, where outliers will be replaced with the next closest non-outlying data point.
A one-way Analysis of Variance (ANOVA) will examine baseline differences between the two conditions on all demographic and dependent variables. If no significant differences are observed at baseline between the two conditions, two-way 2 (condition) X 3 (time) mixed factorial repeated measures ANOVA will be conducted to determine if there are significant changes over time in the intervention and active wait-list control conditions. Any significant interaction terms (condition x time) will be examined using simple slope analysis. Tests of statistical assumptions such as Mauchly's Test of Sphericity and Levene's test for homogeneity of variances will be carried out before the main analyses.
If significant differences are observed at baseline between the two conditions, Analysis of Covariance (ANCOVA) will be conducted, controlling for baseline values. Tests of statistical assumption for ANCOVA such as independence between covariate and independent variable (condition), and homogeneity of regression slopes will be carried out.
For both analyses, if participants in the intervention condition improved significantly on the outcome measures at post-intervention and follow-up compared to participants in the active wait-list control condition, it provides evidence that the intervention is effective in improving body image and self-compassion in university students.
Intent-to-treat analysis will be carried out to address the loss of participants' data due to attrition, by carrying forward the participants' last reported score. Analyses using one-way ANOVA on demographic and dependent variables will be done to determine if there are any significant differences between participants who dropped out and participants who did not. Any significant differences detected can inform of attrition-related biases in the study.
- Conditions
- Body Image
- Being tested
- Self-guided programme on body image, Self-guided programme on cooperation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-guided programme on body imageBehavioural
Participants will download the application from the App store or Google Play store for free. In both programs, participants engage in content learning and short activities daily on the phone application. The anticipated time participants will spend on each program is comparable, of about less than five minutes per day.
Participants complete the same set of questionnaires immediately after completing the program (post-intervention measure), and again at 4 weeks after completing the program (follow-up measure).
At the end of the six weeks data collection period, all participants will be debriefed about the purpose of the study. Participants in the active wait-list control condition will be given access to the body image program.
Self-guided programme on cooperationBehavioural
Participants will download the application from the App store or Google Play store for free. In both programs, participants engage in content learning and short activities daily on the phone application. The anticipated time participants will spend on each program is comparable, of about less than five minutes per day.
Participants complete the same set of questionnaires immediately after completing the program (post-intervention measure), and again at 4 weeks after completing the program (follow-up measure).
At the end of the six weeks data collection period, all participants will be debriefed about the purpose of the study. Participants in the active wait-list control condition will be given access to the body image program.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Body Image | Experimental | Participants will complete a 9-day self-guided programme on body image delivered via a mobile phone application with daily exercises informed by cognitive-behavioural and self-compassion principles. Receives: Behavioral: Self-guided programme on body image |
| Control group | Active comparator | Participants will complete a 9-day self-guided programme on cooperation delivered via a mobile phone application with daily exercises that differ to the intervention group in terms of content but are comparable in terms of duration. Receives: Behavioral: Self-guided programme on cooperation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of baseline body image ideals
Body Image Ideals Questionnaire (BIQ) is a 22-item scale that assesses body image satisfaction-dissatisfaction by measuring the degree of congruence or discrepancy of one's perceived and idealized physical attributes. On a scale from 0 (Exactly as I am) to 3 (Very unlike me), participants rate the degree they resemble their physical ideal on 11 physical attributes. Next, participants rate the importance that they attain their ideal on each physical attribute. The cross-products of the discrepancy and importance ratings for each physical attribute will be obtained and a composite BIQ score will be computed. Higher scores indicate greater disparity between one's perceived and ideal physical attributes, suggesting higher levels of body dissatisfaction. BIQ has good internal consistency, with Cronbach's α of 0.81 for males and 0.76 for females.
Measured: Baseline, 9 days (completion of intervention), 4 weeks (follow-up)
Change of body appreciation
Body Appreciation Scale-2 (BAS-2) is a 10-item scale that assesses individuals' positive attitudes toward their bodies. Items are scored on a scale from 1 (Never) to 5 (Always). Scores on all items are averaged with higher scores indicating greater body appreciation. BAS-2 has excellent internal consistency, with Cronbach's α of 0.96 for males and 0.97 for females
Measured: Baseline, 9 days (completion of intervention), 4 weeks (follow-up)
Change of sociocultural attitudes towards appearance
Sociocultural Attitudes Toward Appearance Questionnaire-4 Revised (SATAQ-4R) measures internalization ideals and appearance related sociocultural pressures. The seven subscales consist of 31 items for females and 28 items for males on a scale from 1 (Definitely disagree) to 5 (Definitely agree). Higher scores on each subscale indicate higher levels of internalisation and sociocultural pressures. The internal consistency of the subscales are good, with Cronbach's α of 0.82 or higher in a sample of university females and Cronbach's α of 0.75 or higher in a sample of university males.
Measured: Baseline, 9 days (completion of intervention), 4 weeks (follow-up)
Change of self-compassion
Self-Compassion Scale-Short Form (SCS-SF) is a 12-item scale that measures self-compassion on six subscales. Each item is scored from 1 (Almost never) to 5 (Almost always). A total self-compassion score is a grand mean of all six subscale means, with higher scores indicating higher levels of self-compassion. The internal consistency of the scale is excellent, with Cronbach's α of 0.86.
Measured: Baseline, 9 days (completion of intervention), 4 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start25 Aug 2021
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
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 Body ImageStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Intellect Pte. Ltd.
- Responsible party
- Principal investigator, Dr Oliver Suendermann, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977973
- Sponsor's protocol ID
- NUS-IRB-2021-85
- Status last verified
- Apr 2022
- First submitted
- 7 Jul 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research data will be stored in an encrypted NUS nbox folder with viewing-only permissions set and restricted to the PI and co-investigator. Primary data will be kept secured in electronic form by the PI and co-investigator in a format that precludes subsequent alteration. Research data files (e.g Excel sheets) will only be accessible by PI and Co-PI. Survey data will be collected on Qualtrics secured with an account password and 2FA verification. Upon completion of the data collection, personal identifiable information(e.g. matric number from RP pool students) will be removed from the Qualtrics file, and the MS Excelsheet containing the data will be encrypted and stored in an encrypted NUS nbox folder, accessible only by the PI and Co-investigator. App data will be linked to a participant code given to participants. However, no personal identifiable data will be collected through the wellbeing app programs. Personal data will be only be shared with PI and Co-I as mentioned above.
Publications
Bakker D, Rickard N. Engagement in mobile phone app for self-monitoring of emotional wellbeing predicts changes in mental health: MoodPrism. J Affect Disord. 2018 Feb;227:432-442. doi: 10.1016/j.jad.2017.11.016. Epub 2017 Nov 9.
PubMed 29154165Bakker D, Kazantzis N, Rickwood D, Rickard N. A randomized controlled trial of three smartphone apps for enhancing public mental health. Behav Res Ther. 2018 Oct;109:75-83. doi: 10.1016/j.brat.2018.08.003. Epub 2018 Aug 11.
PubMed 30125790Cash TF, Szymanski ML. The development and validation of the Body-Image Ideals Questionnaire. J Pers Assess. 1995 Jun;64(3):466-77. doi: 10.1207/s15327752jpa6403_6.
PubMed 16367722Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Franko DL, Cousineau TM, Rodgers RF, Roehrig JP. BodiMojo: effective Internet-based promotion of positive body image in adolescent girls. Body Image. 2013 Sep;10(4):481-8. doi: 10.1016/j.bodyim.2013.04.008. Epub 2013 Jun 13.
PubMed 23768797Raes 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 21584907Rodgers RF, Donovan E, Cousineau T, Yates K, McGowan K, Cook E, Lowy AS, Franko DL. BodiMojo: Efficacy of a Mobile-Based Intervention in Improving Body Image and Self-Compassion among Adolescents. J Youth Adolesc. 2018 Jul;47(7):1363-1372. doi: 10.1007/s10964-017-0804-3. Epub 2018 Jan 18.
PubMed 29349593Schaefer LM, Harriger JA, Heinberg LJ, Soderberg T, Kevin Thompson J. Development and validation of the sociocultural attitudes towards appearance questionnaire-4-revised (SATAQ-4R). Int J Eat Disord. 2017 Feb;50(2):104-117. doi: 10.1002/eat.22590. Epub 2016 Aug 19.
PubMed 27539814Stice E, Becker CB, Yokum S. Eating disorder prevention: current evidence-base and future directions. Int J Eat Disord. 2013 Jul;46(5):478-85. doi: 10.1002/eat.22105.
PubMed 23658095Tukey, J. W., & McLaughlin, D. H. (1963). Less vulnerable confidence and significance procedures for location based on a single sample: Trimming/Winsorization 1. Sankhya. Series A, 25(3), 331-352.
Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.
PubMed 25462882Ong WY, Sundermann O. Efficacy of the Mental Health App "Intellect" to Improve Body Image and Self-compassion in Young Adults: A Randomized Controlled Trial With a 4-Week Follow-up. JMIR Mhealth Uhealth. 2022 Nov 21;10(11):e41800. doi: 10.2196/41800.
PubMed 36409542
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Self-guided Body Image Program on a Mobile Application in Improving Body Image and Self-compassion in Young Adults
- ClinicalTrials.gov ID
- NCT04977973
- Acronym / sponsor ID
- NUS-IRB-2021-85
- Conditions
- Body Image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Intellect Pte. Ltd.
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 27 Jul 2021 (actual)
- 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.
Body image concerns are pervasive and can impact multiple aspects of a person's life. Individuals with negative body image tend to have negative thoughts and feelings about their bodies, often resulting in unhealthy behaviours. Negative body image is also associated with mental and physical health conditions. Thus, prevention efforts are crucial to alleviating body image concerns in young adults as they are considered high-risk populations.
This study is a randomised controlled trial that aims to evaluate the effectiveness of a self-guided body image program on a mobile-based application for young adults.
Hypothesis 1a: The intervention group will improve significantly on measures of body image at post-intervention and follow-up, as compared to the control group.
Hypothesis 1b: The intervention group will reduce significantly on measures of appearance-ideal internalization, media and peer pressures at post-intervention and follow-up, as compared to the control group.
Hypothesis 2: The intervention group will improve significantly on the measure of self-compassion at post intervention and follow-up, as compared to the control group.
Detailed description
Procedure:
Participants will begin by reading the Participant Information Sheet (PIS) online. Once they have indicated consent on the online Consent Form, participants will proceed to complete a set of questionnaire on an online survey platform (Qualtrics) to obtain baseline ratings. The online questionnaire consists of four measures on body image, body image risk factors and self-compassion. Participants will also report demographic information such as gender and age.
Next, participants will download the phone application and be guided to navigate the application. The phone application for the programs in this study is provided by Intellect Pte Ltd, a Singaporean technology start-up company that collaborates with the supervisor of this project (OS). All participants will be randomized to one of two conditions- intervention or active wait-list control-using simple randomisation procedures. Participants in the intervention condition will participate in 9 days of body image program, while participants in the active wait-list control condition will participate in 9 days of cooperation learning program. In both programs, participants will engage in content learning and short activities daily on the phone application. The anticipated time participants will spend on each programs is comparable, of about less than five minutes per day.
Participants will be asked to complete the same set of online questionnaires immediately after completing the program (post-intervention measure), and four weeks after completing the program (follow-up measure). The feedback questionnaire will be administered only post-intervention. Participants will receive either course credit or a small monetary reimbursement after completing the program and questionnaire at post-intervention and at the four weeks follow-up.
At the end of the six weeks data collection period, all participants will be debriefed about the purpose of the study. Participants in the active wait-list control condition will be given access to the body image program.
Outcome Measures:
Body image measures:
Body Image Ideals Questionnaire (BIQ) is a 22-item scale that assesses body image satisfaction-dissatisfaction by measuring the degree of congruence or discrepancy of one's perceived and idealized physical attributes. On a scale from 0 (Exactly as I am) to 3 (Very unlike me), participants rate the degree they resemble their physical ideal on 11 physical attributes. Next, participants rate the importance that they attain their ideal on each physical attribute. The cross-products of the discrepancy and importance ratings for each physical attribute will be obtained and a composite BIQ score will be computed. Higher scores indicate a greater disparity between one's perceived and ideal physical attributes, suggesting higher levels of body dissatisfaction. BIQ has good internal consistency, with Cronbach's α of 0.81 for males and 0.76 for females.
Body Appreciation Scale-2 (BAS-2) is a 10-item scale that assesses individuals' positive attitudes toward their bodies. Items are scored on a scale from 1 (Never) to 5 (Always). Scores on all items are averaged with higher scores indicating greater body appreciation. BAS-2 has excellent internal consistency, with Cronbach's α of 0.96 for males and 0.97 for females.
Risk factor measures:
Sociocultural Attitudes Toward Appearance Questionnaire-4 Revised (SATAQ-4R) measures internalization ideals and appearance-related sociocultural pressures. The seven subscales consist of 31 items for females and 28 items for males on a scale from 1 (definitely disagree) to 5 (Definitely agree). Higher scores on each subscale indicate higher levels of internalisation and sociocultural pressures. The internal consistency of the subscales are good, with Cronbach's α of 0.82 or higher in a sample of university females and Cronbach's α of 0.75 or higher in a sample of university males.
Self-compassion measure:
Self-Compassion Scale-Short Form (SCS-SF) is a 12-item scale that measures self-compassion on six subscales. Each item is scored from 1 (Almost never) to 5 (Almost always). A total self-compassion score is a grand mean of all six subscale means, with higher scores indicating higher levels of self-compassion. The internal consistency of the scale is excellent, with Cronbach's α of 0.86.
Feedback questionnaire:
App Engagement Scale is a 7-item scale that measures participants' engagement on the phone application form 1 (Definitely disagree) to 5 (Definitely agree). A total score is derived by adding scores from each item. The internal reliability of the scale is good, with Cronbach's α of 0.84.
Power analysis and sample size:
Most studies that examined mobile and internet-based body image and eating disorder programs reported intervention effects of small to moderate effect sizes. Using G*power, a small effect size of Cohen's f = 0.1, and alpha = 0.05, an estimated sample size of 214 participants are required to achieve a power of at least 0.90. Taking into consideration a potential attrition rate of 30% in app-based interventions, 280 participants are required.
Statistical analyses:
Statistical analyses will be done using SPSS Version 26.0. All analysis will be conducted using two-tailed test with a level of significance at p < .05.
Data will first be visually inspected using scatterplots, histograms and boxplots to examine the distribution of data and identify significant outliers. Data further than three standard deviations from the mean will be identified as significant outliers. Further analyses will be conducted with and without the outliers to determine if outliers influence the results significantly. If outliers influence results significantly, they will be managed using the Winsorizing method, where outliers will be replaced with the next closest non-outlying data point.
A one-way Analysis of Variance (ANOVA) will examine baseline differences between the two conditions on all demographic and dependent variables. If no significant differences are observed at baseline between the two conditions, two-way 2 (condition) X 3 (time) mixed factorial repeated measures ANOVA will be conducted to determine if there are significant changes over time in the intervention and active wait-list control conditions. Any significant interaction terms (condition x time) will be examined using simple slope analysis. Tests of statistical assumptions such as Mauchly's Test of Sphericity and Levene's test for homogeneity of variances will be carried out before the main analyses.
If significant differences are observed at baseline between the two conditions, Analysis of Covariance (ANCOVA) will be conducted, controlling for baseline values. Tests of statistical assumption for ANCOVA such as independence between covariate and independent variable (condition), and homogeneity of regression slopes will be carried out.
For both analyses, if participants in the intervention condition improved significantly on the outcome measures at post-intervention and follow-up compared to participants in the active wait-list control condition, it provides evidence that the intervention is effective in improving body image and self-compassion in university students.
Intent-to-treat analysis will be carried out to address the loss of participants' data due to attrition, by carrying forward the participants' last reported score. Analyses using one-way ANOVA on demographic and dependent variables will be done to determine if there are any significant differences between participants who dropped out and participants who did not. Any significant differences detected can inform of attrition-related biases in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Body Image | Experimental | Behavioral: Self-guided programme on body imageParticipants will complete a 9-day self-guided programme on body image delivered via a mobile phone application with daily exercises informed by cognitive-behavioural and self-compassion principles. |
| Control group | Active comparator | Behavioral: Self-guided programme on cooperationParticipants will complete a 9-day self-guided programme on cooperation delivered via a mobile phone application with daily exercises that differ to the intervention group in terms of content but are comparable in terms of duration. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-30
- good command of the English language
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Self-guided programme on body imageParticipants will download the application from the App store or Google Play store for free. In both programs, participants engage in content learning and short activities daily on the phone application. The anticipated time participants will spend on each program is comparable, of about less than five minutes per day. Participants complete the same set of questionnaires immediately after completing the program (post-intervention measure), and again at 4 weeks after completing the program (follow-up measure). At the end of the six weeks data collection period, all participants will be debriefed about the purpose of the study. Participants in the active wait-list control condition will be given access to the body image program. | Behavioural | Intervention group: Body Image |
| Self-guided programme on cooperationParticipants will download the application from the App store or Google Play store for free. In both programs, participants engage in content learning and short activities daily on the phone application. The anticipated time participants will spend on each program is comparable, of about less than five minutes per day. Participants complete the same set of questionnaires immediately after completing the program (post-intervention measure), and again at 4 weeks after completing the program (follow-up measure). At the end of the six weeks data collection period, all participants will be debriefed about the purpose of the study. Participants in the active wait-list control condition will be given access to the body image program. | Behavioural | Control group |
Primary outcome
Change of baseline body image ideals
Time frame: Baseline, 9 days (completion of intervention), 4 weeks (follow-up)
Body Image Ideals Questionnaire (BIQ) is a 22-item scale that assesses body image satisfaction-dissatisfaction by measuring the degree of congruence or discrepancy of one's perceived and idealized physical attributes. On a scale from 0 (Exactly as I am) to 3 (Very unlike me), participants rate the degree they resemble their physical ideal on 11 physical attributes. Next, participants rate the importance that they attain their ideal on each physical attribute. The cross-products of the discrepancy and importance ratings for each physical attribute will be obtained and a composite BIQ score will be computed. Higher scores indicate greater disparity between one's perceived and ideal physical attributes, suggesting higher levels of body dissatisfaction. BIQ has good internal consistency, with Cronbach's α of 0.81 for males and 0.76 for females.
Change of body appreciation
Time frame: Baseline, 9 days (completion of intervention), 4 weeks (follow-up)
Body Appreciation Scale-2 (BAS-2) is a 10-item scale that assesses individuals' positive attitudes toward their bodies. Items are scored on a scale from 1 (Never) to 5 (Always). Scores on all items are averaged with higher scores indicating greater body appreciation. BAS-2 has excellent internal consistency, with Cronbach's α of 0.96 for males and 0.97 for females
Change of sociocultural attitudes towards appearance
Time frame: Baseline, 9 days (completion of intervention), 4 weeks (follow-up)
Sociocultural Attitudes Toward Appearance Questionnaire-4 Revised (SATAQ-4R) measures internalization ideals and appearance related sociocultural pressures. The seven subscales consist of 31 items for females and 28 items for males on a scale from 1 (Definitely disagree) to 5 (Definitely agree). Higher scores on each subscale indicate higher levels of internalisation and sociocultural pressures. The internal consistency of the subscales are good, with Cronbach's α of 0.82 or higher in a sample of university females and Cronbach's α of 0.75 or higher in a sample of university males.
Change of self-compassion
Time frame: Baseline, 9 days (completion of intervention), 4 weeks (follow-up)
Self-Compassion Scale-Short Form (SCS-SF) is a 12-item scale that measures self-compassion on six subscales. Each item is scored from 1 (Almost never) to 5 (Almost always). A total self-compassion score is a grand mean of all six subscale means, with higher scores indicating higher levels of self-compassion. The internal consistency of the scale is excellent, with Cronbach's α of 0.86.
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 6 Apr 2022.
- Background: PubMed 29154165Bakker D, Rickard N. Engagement in mobile phone app for self-monitoring of emotional wellbeing predicts changes in mental health: MoodPrism. J Affect Disord. 2018 Feb;227:432-442. doi: 10.1016/j.jad.2017.11.016. Epub 2017 Nov 9.
- Background: PubMed 30125790Bakker D, Kazantzis N, Rickwood D, Rickard N. A randomized controlled trial of three smartphone apps for enhancing public mental health. Behav Res Ther. 2018 Oct;109:75-83. doi: 10.1016/j.brat.2018.08.003. Epub 2018 Aug 11.
- Background: PubMed 16367722Cash TF, Szymanski ML. The development and validation of the Body-Image Ideals Questionnaire. J Pers Assess. 1995 Jun;64(3):466-77. doi: 10.1207/s15327752jpa6403_6.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 23768797Franko DL, Cousineau TM, Rodgers RF, Roehrig JP. BodiMojo: effective Internet-based promotion of positive body image in adolescent girls. Body Image. 2013 Sep;10(4):481-8. doi: 10.1016/j.bodyim.2013.04.008. Epub 2013 Jun 13.
- 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 29349593Rodgers RF, Donovan E, Cousineau T, Yates K, McGowan K, Cook E, Lowy AS, Franko DL. BodiMojo: Efficacy of a Mobile-Based Intervention in Improving Body Image and Self-Compassion among Adolescents. J Youth Adolesc. 2018 Jul;47(7):1363-1372. doi: 10.1007/s10964-017-0804-3. Epub 2018 Jan 18.
- Background: PubMed 27539814Schaefer LM, Harriger JA, Heinberg LJ, Soderberg T, Kevin Thompson J. Development and validation of the sociocultural attitudes towards appearance questionnaire-4-revised (SATAQ-4R). Int J Eat Disord. 2017 Feb;50(2):104-117. doi: 10.1002/eat.22590. Epub 2016 Aug 19.
- Background: PubMed 23658095Stice E, Becker CB, Yokum S. Eating disorder prevention: current evidence-base and future directions. Int J Eat Disord. 2013 Jul;46(5):478-85. doi: 10.1002/eat.22105.
- BackgroundTukey, J. W., & McLaughlin, D. H. (1963). Less vulnerable confidence and significance procedures for location based on a single sample: Trimming/Winsorization 1. Sankhya. Series A, 25(3), 331-352.
- Background: PubMed 25462882Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.
- Derived from this study: PubMed 36409542Ong WY, Sundermann O. Efficacy of the Mental Health App "Intellect" to Improve Body Image and Self-compassion in Young Adults: A Randomized Controlled Trial With a 4-Week Follow-up. JMIR Mhealth Uhealth. 2022 Nov 21;10(11):e41800. doi: 10.2196/41800.
- Individual participant dataSharing planned: No. Research data will be stored in an encrypted NUS nbox folder with viewing-only permissions set and restricted to the PI and co-investigator. Primary data will be kept secured in electronic form by the PI and co-investigator in a format that precludes subsequent alteration. Research data files (e.g Excel sheets) will only be accessible by PI and Co-PI. Survey data will be collected on Qualtrics secured with an account password and 2FA verification. Upon completion of the data collection, personal identifiable information(e.g. matric number from RP pool students) will be removed from the Qualtrics file, and the MS Excelsheet containing the data will be encrypted and stored in an encrypted NUS nbox folder, accessible only by the PI and Co-investigator. App data will be linked to a participant code given to participants. However, no personal identifiable data will be collected through the wellbeing app programs. Personal data will be only be shared with PI and Co-I as mentioned above.
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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 Self-guided programme on body image and Self-guided programme on cooperation in people with Body Image, run by National University of Singapore at 1 site in Singapore.
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 1 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 6 Apr 2022. 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 Singapore. 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?
Change of baseline body image ideals (time frame: Baseline, 9 days (completion of intervention), 4 weeks (follow-up)). The study lists 4 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 NCT04977973, 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 6 Apr 2022.