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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05684263
Other study ID # STJOES2022WCB
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 9, 2023
Est. completion date September 30, 2023

Study information

Verified date January 2023
Source St. Joseph's Healthcare Hamilton
Contact Michele Laliberte, PhD
Phone (905) 522-1155
Email mlaliber@stjoes.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date September 30, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 17 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Weight Science Educational Video
Educational videos on the topic of weight science created by a registered clinical psychologist.
Healthy Eating Educational Video
Educational videos on the topic of healthy eating created by a registered clinical psychologist.
Healthy Sleep Educational Video
Educational videos on the topic of healthy sleep created by a registered clinical psychologist.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
St. Joseph's Healthcare Hamilton

References & Publications (5)

Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70. — View Citation

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.

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Primary 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.
Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Secondary 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).
Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Secondary 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).
Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Secondary 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).
Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Secondary 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).
Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
Secondary 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).
Baseline (questionnaires administered prior to watching videos) and Post-Intervention (questionnaires administered after watching the videos) approximately 1 hour after completing baseline questionnaires.
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