- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05684263
The Effects of Weight Science and Nutrition Education on Weight Control Beliefs and Disordered Eating.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michele Laliberte, PhD
- Phone Number: 33433 (905) 522-1155
- Email: mlaliber@stjoes.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 17 years of age or older
- Female
- Normal hearing with or without listening device
Exclusion Criteria:
- Currently diagnosed with an eating disorder
- Has received treatment for an eating disorder at any point in time
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Weight Science + Healthy Eating Education
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.
|
Educational videos on the topic of weight science created by a registered clinical psychologist.
Educational videos on the topic of healthy eating created by a registered clinical psychologist.
|
|
Other: Weight Science + Healthy Sleep Education
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. |
Educational videos on the topic of weight science created by a registered clinical psychologist.
Educational videos on the topic of healthy sleep created by a registered clinical psychologist.
|
|
Other: Healthy Eating + Healthy Sleep Education
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. |
Educational videos on the topic of healthy eating created by a registered clinical psychologist.
Educational videos on the topic of healthy sleep created by a registered clinical psychologist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
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
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. |
Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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). |
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.
|
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). |
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.
|
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). |
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.
|
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). |
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.
|
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). |
Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michele Laliberte, PhD, St. Joseph's Healthcare Hamilton
Publications and helpful links
General Publications
- Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
- 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.
- Wilkerson AH, Hackman CL, Rush SE, Usdan SL, Smith CS. "Drunkorexia": Understanding eating and physical activity behaviors of weight conscious drinkers in a sample of college students. J Am Coll Health. 2017 Oct;65(7):492-501. doi: 10.1080/07448481.2017.1344848. Epub 2017 Jun 22.
- 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 record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STJOES2022WCB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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