- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03991676
A Study of a Values-Based Intervention to Promote Weight Loss
October 22, 2019 updated by: Diane Dallal, Drexel University
Clarifying the Role of Values in Weight Control: A Pilot Study of a Values-Based Intervention to Promote Weight Loss
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Drexel University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Measured at post-treatment (1 month).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Measured at baseline and post-treatment (1 month) assessments.
|
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.
|
Measured at baseline and post-treatment (1 month) assessments.
|
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.
|
Measured at baseline and post-treatment (1 month) assessments.
|
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).
|
Measured at baseline, 1 week, 2 weeks, 3 weeks, and post-treatment (1 month) assessment.
|
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.
|
Measured at baseline and post-treatment (1 month) assessments.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Diane H Dallal, B.A., Drexel University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 29, 2019
Primary Completion (Actual)
September 13, 2019
Study Completion (Actual)
September 13, 2019
Study Registration Dates
First Submitted
May 19, 2019
First Submitted That Met QC Criteria
June 17, 2019
First Posted (Actual)
June 19, 2019
Study Record Updates
Last Update Posted (Actual)
October 24, 2019
Last Update Submitted That Met QC Criteria
October 22, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DrexelUniversity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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