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

NCT03991676 | Completed

• 1 other identifier: DrexelUniversity
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Keywords

Obesity; Weight Loss; Behavioral treatment; Values; Values-based behavior change; Autonomous motivation; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Measured at post-treatment (1 month).

Secondary Outcomes (5)

• Values clarity

  Measured at baseline and post-treatment (1 month) assessments.

• Values awareness

  Measured at baseline and post-treatment (1 month) assessments.

• Values-congruent weight control behavior

  Measured at baseline and post-treatment (1 month) assessments.

• Weight

  Measured at baseline, 1 week, 2 weeks, 3 weeks, and post-treatment (1 month) assessment.

• Autonomous motivation

  Measured at baseline and post-treatment (1 month) assessments.

Study Arms (1)

Values-Based Behavioral Treatment

EXPERIMENTAL

Behavioral: Values-Based Behavioral Treatment

Interventions

Values-Based Behavioral Treatment 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.

Values-Based Behavioral Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Diane H Dallal, B.A.

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Model Details: All participants are enrolled into a single condition, consisting of a series of three, once-weekly values-infused weight loss workshops.

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: June 19, 2019
• Study Start: April 29, 2019
• Primary Completion: September 13, 2019
• Study Completion: September 13, 2019
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)