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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
Sponsor:
Information provided by (Responsible Party):
Diane Dallal, Drexel University

Brief Summary:
More than 160 million American adults are overweight or obese. Existing weight loss interventions from self-help to gold standard behavioral treatments, while often effective, do not sufficiently maintain motivation to adhere to dietary goals in the face of powerful biological and environmental influences to consume highly palatable foods. Clarification and awareness of values, a staple of acceptance-based treatments drawn from Acceptance and Commitment Therapy, are thought to enhance autonomous motivation to engage in behaviors consistent with one's personal life values (e.g., health) in the presence of countervailing forces (e.g., hunger, deprivation). However, the independent efficacy of values clarification and awareness in facilitating weight control has never been tested. This pilot study seeks to investigate the feasibility and acceptability of a series of three weight loss workshops (based off the gold standard) infused with values clarification and awareness techniques to promote weight control. Participants will be asked to follow a reduced-calorie dietary prescription while holding their values in mind in moments of dietary decision-making over the course of one month. The primary aims of this study are to: 1) develop the series of values-infused workshops, using participant feedback to iterate and improve the treatment manual; and 2) evaluate treatment acceptability. Secondary aims are: 1) to evaluate whether clinically meaningful changes in measures of values clarification and values awareness occur; 2) to evaluate whether the intervention will lead participants to experience clinically meaningful changes in values-congruent weight control behaviors; 3) to evaluate whether the intervention will lead participants to experience clinically meaningful changes in weight; and 4) to evaluate theorized mechanisms of action in the intervention.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Behavioral: Values-Based Behavioral Treatment Not Applicable

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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI of 25-55 kg/m2
  • 18-70 years of age
  • Have a desire to lose weight
  • Own a smartphone
  • Live in the Philadelphia area
  • Provide informed consent

Exclusion Criteria:

  • Any medical or psychiatric conditions (e.g., eating disorder, diabetes) that may pose a risk to the participant during the intervention, cause a change in weight or appetite, or interfere with ability to adhere to diet recommendations
  • Recent change in medication dosage that could affect weight or appetite
  • Current or planned pregnancy in the next month
  • Planned move out of the Philadelphia area in the next month
  • History of bariatric surgery
  • Weight loss of ≥5% in the last six months
  • Concurrent behavioral therapy targeting weight control

Information from the National Library of Medicine

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


Contacts
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Contact: Project Coordinator (215) 553-7111 projectclarity@drexel.edu

Locations
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United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Project Coordinator    215-553-7111    projectclarity@drexel.edu   
Sponsors and Collaborators
Drexel University
Investigators
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Principal Investigator: Diane H Dallal, B.A. Drexel University

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Responsible Party: Diane Dallal, Graduate Student, Drexel University
ClinicalTrials.gov Identifier: NCT03991676     History of Changes
Other Study ID Numbers: DrexelUniversity
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diane Dallal, Drexel University:
Obesity
Weight Loss
Behavioral treatment
Values
Values-based behavior change
Autonomous motivation
Acceptance and Commitment Therapy
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes