NCT04977973

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

August 25, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

July 7, 2021

Last Update Submit

April 4, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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.

    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.

    Baseline, 9 days (completion of intervention), 4 weeks (follow-up)

Other Outcomes (1)

  • Engagement with the mobile application

    9 days (completion of programme)

Study Arms (2)

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.

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.

Behavioral: Self-guided programme on cooperation

Interventions

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.

Intervention group: Body Image

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.

Control group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-30
  • good command of the English language

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore

Singapore, Singapore

Location

Related Publications (12)

  • 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.

    PMID: 29154165BACKGROUND
  • Bakker 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.

    PMID: 30125790BACKGROUND
  • Cash 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.

    PMID: 16367722BACKGROUND
  • Faul 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.

    PMID: 17695343BACKGROUND
  • Franko 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.

    PMID: 23768797BACKGROUND
  • 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.

    PMID: 21584907BACKGROUND
  • Rodgers 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.

    PMID: 29349593BACKGROUND
  • Schaefer 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.

    PMID: 27539814BACKGROUND
  • Stice 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.

    PMID: 23658095BACKGROUND
  • Tukey, 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
  • 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.

    PMID: 25462882BACKGROUND
  • Ong 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director Master in Clinical Psychology Program

Study Record Dates

First Submitted

July 7, 2021

First Posted

July 27, 2021

Study Start

August 25, 2021

Primary Completion

January 10, 2022

Study Completion

January 10, 2022

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

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.

Locations