A Study of a Values-Based Intervention to Promote Weight Loss

Sponsor

Drexel University (Other)

Overall Status

Completed

CT.gov ID

NCT03991676

Collaborator

(none)

Enrollment

Location

Arm

4.5

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Weight Loss	Behavioral: Values-Based Behavioral Treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

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.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 :

Apr 29, 2019

Actual Primary Completion Date :

Sep 13, 2019

Actual Study Completion Date :

Sep 13, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Participant acceptability and satisfaction with the intervention [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

Values clarity [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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