A Study of a Values-Based Intervention to Promote Weight Loss
Primary Purpose
Obesity, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Values-Based Behavioral Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight Loss, Behavioral treatment, Values, Values-based behavior change, Autonomous motivation, Acceptance and Commitment Therapy
Eligibility 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
Sites / Locations
- Drexel University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Values-Based Behavioral Treatment
Arm Description
Outcomes
Primary Outcome Measures
Participant acceptability and satisfaction with the intervention
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
Values clarity
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
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
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
Weight will be measured in street clothes without shoes using a lab-grade, standardized Seca® scale (accurate to 0.1 kg).
Autonomous motivation
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03991676
Brief Title
A Study of a Values-Based Intervention to Promote Weight Loss
Official Title
Clarifying the Role of Values in Weight Control: A Pilot Study of a Values-Based Intervention to Promote Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
September 13, 2019 (Actual)
Study Completion Date
September 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Obesity, Weight Loss, Behavioral treatment, Values, Values-based behavior change, Autonomous motivation, Acceptance and Commitment Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Values-Based Behavioral Treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Values-Based Behavioral Treatment
Intervention Description
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 Measure Information:
Title
Participant acceptability and satisfaction with the intervention
Description
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.
Time Frame
Measured at post-treatment (1 month).
Secondary Outcome Measure Information:
Title
Values clarity
Description
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.
Time Frame
Measured at baseline and post-treatment (1 month) assessments.
Title
Values awareness
Description
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.
Time Frame
Measured at baseline and post-treatment (1 month) assessments.
Title
Values-congruent weight control behavior
Description
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.
Time Frame
Measured at baseline and post-treatment (1 month) assessments.
Title
Weight
Description
Weight will be measured in street clothes without shoes using a lab-grade, standardized Seca® scale (accurate to 0.1 kg).
Time Frame
Measured at baseline, 1 week, 2 weeks, 3 weeks, and post-treatment (1 month) assessment.
Title
Autonomous motivation
Description
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.
Time Frame
Measured at baseline and post-treatment (1 month) assessments.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane H Dallal, B.A.
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of a Values-Based Intervention to Promote Weight Loss
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