A Study of a Values-Based Intervention to Promote Weight Loss
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|ClinicalTrials.gov Identifier: NCT03991676|
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Weight Loss||Behavioral: Values-Based Behavioral Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants are enrolled into a single condition, consisting of a series of three, once-weekly values-infused weight loss workshops.|
|Masking:||None (Open Label)|
|Official Title:||Clarifying the Role of Values in Weight Control: A Pilot Study of a Values-Based Intervention to Promote Weight Loss|
|Actual Study Start Date :||April 29, 2019|
|Estimated Primary Completion Date :||August 1, 2019|
|Estimated Study Completion Date :||August 1, 2019|
|Experimental: Values-Based Behavioral Treatment||
Behavioral: Values-Based Behavioral Treatment
The values-based behavioral treatment will consist of a series of three, once-weekly weight loss workshops infused with techniques to elicit values clarification and awareness in moments of dietary decision-making, and to enhance autonomous motivation for behavior change.
- Participant acceptability and satisfaction with the intervention [ Time Frame: Measured at post-treatment (1 month). ]Participant acceptability and satisfaction with the intervention will be assessed using an idiosyncratic self-report Acceptability Questionnaire, developed for the present study. Questions include items assessing how satisfied participants were with the intervention, how helpful they found it, and how likely they would be to recommend it to others. Scores range from 1 to 5 for each item, where higher values represent greater satisfaction and acceptability.
- Values clarity [ Time Frame: Measured at baseline and post-treatment (1 month) assessments. ]Values clarity will be measured with the Values Clarity and Awareness Interview (VCAI), an unstructured clinical interview adapted from a previous self-report measure of values clarity constructed by Forman and colleagues. The VCAI was chosen because it is the only existing measure of values clarity. Scores range from 0 to 3 for each value described, where higher values represent greater values clarity. Scores for each value described are then averaged to compute an overall clarity score.
- Values awareness [ Time Frame: Measured at baseline and post-treatment (1 month) assessments. ]Values awareness will be measured with the Values Clarity and Awareness Interview (VCAI), an unstructured clinical interview adapted from a previous self-report measure of values clarity constructed by Forman and colleagues. The VCAI was chosen because it is the only existing measure of values awareness. Scores range from 0 to 4, where higher values represent greater values awareness.
- Values-congruent weight control behavior [ Time Frame: Measured at baseline and post-treatment (1 month) assessments. ]The consistency with which individuals enact weight control behaviors in accordance with their values will be measured using an adapted Valued Living Questionnaire (VLQ) that assesses valued living as it relates to weight control in particular. Scores range from 1-10 for each of 10 valued domains of living, where higher scores represent greater personal importance and consistency with one's values.
- Weight [ Time Frame: Measured at baseline, 1 week, 2 weeks, 3 weeks, and post-treatment (1 month) assessment. ]Weight will be measured in street clothes without shoes using a lab-grade, standardized Seca® scale (accurate to 0.1 kg).
- Autonomous motivation [ Time Frame: Measured at baseline and post-treatment (1 month) assessments. ]Autonomous motivation to enact health behaviors will be measured using the Autonomous Motivation subscale of an adapted Treatment Self-Regulation Questionnaire (TSRQ) for weight loss. Scores range from 1-7, where higher scores represent greater autonomous motivation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991676
|Contact: Project Coordinator||(215) email@example.com|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Project Coordinator 215-553-7111 firstname.lastname@example.org|
|Principal Investigator:||Diane H Dallal, B.A.||Drexel University|