Body ImageNCT05684263
The Effects of Weight Science and Nutrition Education on Weight Control Beliefs and Disordered Eating.
A study testing Weight Science Educational Video, Healthy Eating Educational Video and Healthy Sleep Educational Video in people with Body Image and Eating, Healthy, run by St. Joseph's Healthcare Hamilton.
Trial summary
People have different beliefs about controlling their weight. Individuals who believe they should control their weight are more likely to have poor body image, low self-esteem and disordered eating. Read more about this study
- Who is it for?
- Ages 17 years and older, women only
- Conditions the study is for
- Body Image, Eating, Healthy
- What is being tested?
- Weight Science Educational Video, Healthy Eating Educational Video and Healthy Sleep Educational Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2023to 30 Sep 2023
- 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 17 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 17 years of age or older
- Female
- Normal hearing with or without listening device
Who cannot join
- Currently diagnosed with an eating disorder
- Has received treatment for an eating disorder at any point in time
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Experimental Study of the Effects of Weight Science and Nutrition Education on Weight Control Beliefs and Disordered Eating in a Non-clinical Female Sample.
People have different beliefs about controlling their weight. Individuals who believe they should control their weight are more likely to have poor body image, low self-esteem and disordered eating. Individuals who believe they should aim for a healthy lifestyle and accept their natural weight have better body image, better self-esteem and less disordered eating. This study investigates the impact of three types of education on participants' beliefs about controlling weight: 1) education about the body's natural regulation of weight; or 2) education about healthy nutrition; or 3) education about both the body's regulation of weight and healthy nutrition. The study will also investigate whether changing participants' beliefs about controlling weight impacts participants' body satisfaction, feelings about themselves and intention to diet. It is predicted that teaching both about the body's regulation of weight and healthy eating will decrease participants' belief in personal control over weight, and increase participants' belief in striving for a healthy lifestyle and accepting their natural weight. In turn, these changes in weight control beliefs are expect to predict improved body satisfaction, feelings about themselves and a lower intention to diet.
Read the detailed description
Participants will be randomly assigned to one of three conditions: 1) weight science + control (sleep education); 2) control (sleep education) + healthy nutrition education; or 3) weight science + healthy nutrition education. Participants will be randomly assigned to one of the three conditions by an algorithm in REDCap. The same procedure will be used for each condition, with the exception of what education is provided.
After the online consent form is completed, participants will be automatically redirected to the study questionnaires in REDCap. Participants will complete a package of questionnaires pre- and post- intervention measuring demographic information, physical activity, knowledge of weight science, weight control beliefs, self-esteem, restrained eating, body appreciation, self-compassion for weight and shape and fear of self-compassion for weight and shape. Participants will complete the package of questionnaires prior to watching two educational videos embedded into the REDCap project, and then complete the same package of questionnaires again.
After watching the educational videos and completing the study questionnaires, participants will receive a copy of the debriefing form, which provides further information about the study purpose, independent and dependent variables, local mental health resources, and contact information for the LPI. The debriefing form will be emailed to participants via McMaster Outlook using the email encryption function. If participants do not complete the study questionnaires, the debriefing form will be sent to participants after their study time slot has closed.
The data will be collected and stored through the secure online data collection platform REDCap, which is managed by St. Joseph's Healthcare Hamilton. REDCap is a secure, encrypted data collection platform that requires two-factor authentication for access to study data. REDCap is located within the secure internal SJHH network, and is protected by firewall software (Checkpoint software).
- Conditions
- Body Image, Eating, Healthy
- Being tested
- Weight Science Educational Video, Healthy Eating Educational Video, Healthy Sleep Educational Video
- Keywords
- Body Image, Weight control beliefs, Diet, Weight Loss, Eating, Healthy
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Science Educational VideoOther
Educational videos on the topic of weight science created by a registered clinical psychologist.
Healthy Eating Educational VideoOther
Educational videos on the topic of healthy eating created by a registered clinical psychologist.
Healthy Sleep Educational VideoOther
Educational videos on the topic of healthy sleep created by a registered clinical psychologist.
| Study group | Role | What they receive |
|---|---|---|
| Weight Science + Healthy Eating Education | Experimental | In this condition participants will watch two educational videos on the topics of weight science, and healthy eating. The videos were created by a registered psychologist and are each between 20 and 30 minutes in length. Receives: Other: Weight Science Educational Video; Other: Healthy Eating Educational Video |
| Weight Science + Healthy Sleep Education | Other | In this condition participants will watch two educational videos on the topics of weight science, and healthy sleep. The videos were created by a registered psychologist and are each between 20 and 30 minutes in length.
We are interested in the effect of weight science education alone, the healthy sleep video was added as an active control so that each condition was watching the same amount of videos. Receives: Other: Weight Science Educational Video; Other: Healthy Sleep Educational Video |
| Healthy Eating + Healthy Sleep Education | Other | In this condition participants will watch two educational videos on the topics of healthy eating, and healthy sleep. The videos were created by a registered psychologist and are each between 20 and 30 minutes in length.
We are interested in the effect of healthy eating education alone, the healthy sleep video was added as an active control so that each condition was watching the same amount of videos. Receives: Other: Healthy Eating Educational Video; Other: Healthy Sleep Educational Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measure of the Belief in Controlling Weight scale from baseline to post-intervention
Weight Control Beliefs Questionnaire - Belief in Control over Weight (BCWeight) scale. This is a validated self-report measure of the individual's belief in personal control over weight.
The minimum score is 9 (low belief in controlling weight) and the maximum score is 36 (high belief in controlling weight). A higher score has been associated with negative/worse outcomes.
Measured: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Change in measure of the Belief in Controlling Lifestyle scale from baseline to post-intervention
Weight Control Beliefs Questionnaire - Belief in Control over Lifestyle (BCLifestyle) scale. This is a validated self-report measure of the individual's belief in striving for a healthy lifestyle with acceptance of the resulting weight.
The minimum score is 8 (low belief in striving for a healthy lifestyle with acceptance of resulting weight) and the maximum score is 32 (high belief in striving for a healthy lifestyle with acceptance of resulting weight). A higher score has been associated with positive/better outcomes.
Measured: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Secondary outcomes (5)
Change in measure of Self-Esteem from baseline to post-intervention
Rosenberg Self-Esteem Scale. This is a validated self-report measure of self-esteem.
The minimum score is 10 and the maximum score is 40. A higher score indicates higher self-esteem (positive/better outcome).
Measured: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Change in measure of Intentions to engage in dietary restraint from baseline to post-intervention
The Eating Disorder Examination Questionnaire - Restraint Sub-scale, modified to assess intentions to engage in dietary restraint rather than dietary restraint over the past 28 days. Items are otherwise identical to original scale, which is a well-validated self-report measure.
The minimum score is 0 and the maximum score is 25. A higher score indicates greater intentions to engage in dietary restraint (negative/worse outcome).
Measured: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Change in measure of Body Appreciation from baseline to post-intervention
Body Appreciation Scale - 2. This is a well-validated self-report measure of positive attitudes towards one's body.
The minimum score is 10 and the maximum score is 50. A higher score indicates greater appreciation for one's body (positive/better outcome).
Measured: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Change in measure of Fear of Self-Compassion for Weight and Shape from baseline to post-intervention
Fear of Self-Compassion for Weight and Shape Scale. This scale is based on the Fear of Self-Compassion Scale (a well-validated self-report measure) with items modified to measure a fear of self-compassion for one's weight and shape. Items are otherwise identical to the original scale and recent findings suggests the modified scale has maintained its psychometric properties.
The minimum score is 15 and the maximum score is 75. A higher score indicates more fear of self-compassion for ones weight and shape (a negative/worse outcome).
Measured: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Change in measure of Self-Compassion for Weight & Shape from baseline to post-intervention
Self-Compassion for Weight \& Shape Scale. This scale is based on the Self-Compassion scale (a well-validated self-report measure), modified to measure self-compassion for weight and shape. Items are otherwise identical to the original scale and recent findings suggest the modified scale retains good psychometric properties.
The minimum score is 12 and the maximum score is 60. A higher score indicates more self-compassion for ones weight and shape (a positive/better outcome).
Measured: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start9 Jan 2023 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Body ImageStudies 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
- Model description
- There are three conditions in the study, which correspond to what education the participant will receive. The participant will be randomly assigned to one of the three conditions.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Laliberte, St. Joseph's Healthcare Hamilton
- Investigators
- Michele Laliberte, PhD, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684263
- Sponsor's protocol ID
- STJOES2022WCB
- Status last verified
- Jan 2023
- First submitted
- 29 Nov 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 25462882Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
PubMed 7866415Craig C, Marshall A, Sjostrom M, Bauman A, Lee P, Macfarlane D, Lam T, & Stewart S. International physical activity questionnaire-short form. Journal of American College Health. 2017; 65(7): 492-501.
Laliberte MM, Newton M, McCabe R, & Mills JS. Controlling Your Weight Versus Controlling Your Lifestyle: How Beliefs about Weight Control Affect Risk for Disordered Eating, 10534_2006_9060_Fig3_HTML.gif Dissatisfaction and Self-esteem. Cognitive Therapy and Research. 2007; 31(6): 853-869.
Rosenberg M. Society and the Adolescent Self-Image (Revised edition). Wesleyan University Press. 1989.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Experimental Study of the Effects of Weight Science and Nutrition Education on Weight Control Beliefs and Disordered Eating in a Non-clinical Female Sample.
- ClinicalTrials.gov ID
- NCT05684263
- Acronym / sponsor ID
- STJOES2022WCB
- Conditions
- Body Image, Eating, Healthy
- Keywords
- Body Image, Weight control beliefs, Diet, Weight Loss, Eating, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 9 Jan 2023 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 13 Jan 2023 (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.
People have different beliefs about controlling their weight. Individuals who believe they should control their weight are more likely to have poor body image, low self-esteem and disordered eating. Individuals who believe they should aim for a healthy lifestyle and accept their natural weight have better body image, better self-esteem and less disordered eating. This study investigates the impact of three types of education on participants' beliefs about controlling weight: 1) education about the body's natural regulation of weight; or 2) education about healthy nutrition; or 3) education about both the body's regulation of weight and healthy nutrition. The study will also investigate whether changing participants' beliefs about controlling weight impacts participants' body satisfaction, feelings about themselves and intention to diet. It is predicted that teaching both about the body's regulation of weight and healthy eating will decrease participants' belief in personal control over weight, and increase participants' belief in striving for a healthy lifestyle and accepting their natural weight. In turn, these changes in weight control beliefs are expect to predict improved body satisfaction, feelings about themselves and a lower intention to diet.
Detailed description
Participants will be randomly assigned to one of three conditions: 1) weight science + control (sleep education); 2) control (sleep education) + healthy nutrition education; or 3) weight science + healthy nutrition education. Participants will be randomly assigned to one of the three conditions by an algorithm in REDCap. The same procedure will be used for each condition, with the exception of what education is provided.
After the online consent form is completed, participants will be automatically redirected to the study questionnaires in REDCap. Participants will complete a package of questionnaires pre- and post- intervention measuring demographic information, physical activity, knowledge of weight science, weight control beliefs, self-esteem, restrained eating, body appreciation, self-compassion for weight and shape and fear of self-compassion for weight and shape. Participants will complete the package of questionnaires prior to watching two educational videos embedded into the REDCap project, and then complete the same package of questionnaires again.
After watching the educational videos and completing the study questionnaires, participants will receive a copy of the debriefing form, which provides further information about the study purpose, independent and dependent variables, local mental health resources, and contact information for the LPI. The debriefing form will be emailed to participants via McMaster Outlook using the email encryption function. If participants do not complete the study questionnaires, the debriefing form will be sent to participants after their study time slot has closed.
The data will be collected and stored through the secure online data collection platform REDCap, which is managed by St. Joseph's Healthcare Hamilton. REDCap is a secure, encrypted data collection platform that requires two-factor authentication for access to study data. REDCap is located within the secure internal SJHH network, and is protected by firewall software (Checkpoint software).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are three conditions in the study, which correspond to what education the participant will receive. The participant will be randomly assigned to one of the three conditions.
| Arm | Type | Receives |
|---|---|---|
| Weight Science + Healthy Eating Education | Experimental | Other: Weight Science Educational Video, Other: Healthy Eating Educational VideoIn this condition participants will watch two educational videos on the topics of weight science, and healthy eating. The videos were created by a registered psychologist and are each between 20 and 30 minutes in length. |
| Weight Science + Healthy Sleep Education | Other | Other: Weight Science Educational Video, Other: Healthy Sleep Educational VideoIn this condition participants will watch two educational videos on the topics of weight science, and healthy sleep. The videos were created by a registered psychologist and are each between 20 and 30 minutes in length. We are interested in the effect of weight science education alone, the healthy sleep video was added as an active control so that each condition was watching the same amount of videos. |
| Healthy Eating + Healthy Sleep Education | Other | Other: Healthy Eating Educational Video, Other: Healthy Sleep Educational VideoIn this condition participants will watch two educational videos on the topics of healthy eating, and healthy sleep. The videos were created by a registered psychologist and are each between 20 and 30 minutes in length. We are interested in the effect of healthy eating education alone, the healthy sleep video was added as an active control so that each condition was watching the same amount of videos. |
Who may qualify
- Ages
- 17 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 17 years of age or older
- Female
- Normal hearing with or without listening device
Key exclusion criteria (2 listed)
- Currently diagnosed with an eating disorder
- Has received treatment for an eating disorder at any point in time
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 |
|---|---|---|
| Weight Science Educational VideoEducational videos on the topic of weight science created by a registered clinical psychologist. | Other | Weight Science + Healthy Eating Education, Weight Science + Healthy Sleep Education |
| Healthy Eating Educational VideoEducational videos on the topic of healthy eating created by a registered clinical psychologist. | Other | Healthy Eating + Healthy Sleep Education, Weight Science + Healthy Eating Education |
| Healthy Sleep Educational VideoEducational videos on the topic of healthy sleep created by a registered clinical psychologist. | Other | Healthy Eating + Healthy Sleep Education, Weight Science + Healthy Sleep Education |
Primary outcome
Change in measure of the Belief in Controlling Weight scale from baseline to post-intervention
Time frame: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Weight Control Beliefs Questionnaire - Belief in Control over Weight (BCWeight) scale. This is a validated self-report measure of the individual's belief in personal control over weight. The minimum score is 9 (low belief in controlling weight) and the maximum score is 36 (high belief in controlling weight). A higher score has been associated with negative/worse outcomes.
Change in measure of the Belief in Controlling Lifestyle scale from baseline to post-intervention
Time frame: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Weight Control Beliefs Questionnaire - Belief in Control over Lifestyle (BCLifestyle) scale. This is a validated self-report measure of the individual's belief in striving for a healthy lifestyle with acceptance of the resulting weight. The minimum score is 8 (low belief in striving for a healthy lifestyle with acceptance of resulting weight) and the maximum score is 32 (high belief in striving for a healthy lifestyle with acceptance of resulting weight). A higher score has been associated with positive/better outcomes.
5 secondary outcomes
Change in measure of Self-Esteem from baseline to post-intervention
Time frame: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Change in measure of Intentions to engage in dietary restraint from baseline to post-intervention
Time frame: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Change in measure of Body Appreciation from baseline to post-intervention
Time frame: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Change in measure of Fear of Self-Compassion for Weight and Shape from baseline to post-intervention
Time frame: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Change in measure of Self-Compassion for Weight & Shape from baseline to post-intervention
Time frame: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- 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.
- Background: PubMed 7866415Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
- BackgroundCraig C, Marshall A, Sjostrom M, Bauman A, Lee P, Macfarlane D, Lam T, & Stewart S. International physical activity questionnaire-short form. Journal of American College Health. 2017; 65(7): 492-501.
- BackgroundLaliberte MM, Newton M, McCabe R, & Mills JS. Controlling Your Weight Versus Controlling Your Lifestyle: How Beliefs about Weight Control Affect Risk for Disordered Eating, 10534_2006_9060_Fig3_HTML.gif Dissatisfaction and Self-esteem. Cognitive Therapy and Research. 2007; 31(6): 853-869.
- BackgroundRosenberg M. Society and the Adolescent Self-Image (Revised edition). Wesleyan University Press. 1989.
- 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.
Michele Laliberte, PhD principal investigator
St. Joseph's Healthcare Hamilton
Questions about this trial
What is this clinical trial studying?
A study testing Weight Science Educational Video, Healthy Eating Educational Video and Healthy Sleep Educational Video in people with Body Image and Eating, Healthy, run by St. Joseph's Healthcare Hamilton.
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 3 inclusion and 2 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 13 Jan 2023. 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. 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?
Contact Michele Laliberte, PhD ((905) 522-1155 ext. 33433, mlaliber@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in measure of the Belief in Controlling Weight scale from baseline to post-intervention (time frame: Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.). The study lists 2 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 NCT05684263, which also lists 5 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 13 Jan 2023.