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

NCT ID: NCT03991676

Last Updated: 2019-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2019-09-13

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.

Conditions

Obesity; Weight Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Values-Based Behavioral Treatment

Group Type: EXPERIMENTAL

Values-Based Behavioral Treatment

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Diane Dallal

Graduate Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diane H Dallal, B.A.

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

DrexelUniversity

Identifier Type: -

Identifier Source: org_study_id