4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / A Study of a Values-Based Intervention to Promote Weight Loss

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

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 Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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.
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 : April 29, 2019
Actual Primary Completion Date : September 13, 2019
Actual Study Completion Date : September 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.
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Drexel University
Investigators
Layout table for investigator information
Principal Investigator: Diane H Dallal, B.A. Drexel University
Tracking Information
First Submitted Date  ICMJE May 19, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date October 24, 2019
Actual Study Start Date  ICMJE April 29, 2019
Actual Primary Completion Date September 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of a Values-Based Intervention to Promote Weight Loss
Official Title  ICMJE Clarifying the Role of Values in Weight Control: A Pilot Study of a Values-Based Intervention to Promote Weight Loss
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Weight Loss
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Values-Based Behavioral Treatment
Intervention: Behavioral: Values-Based Behavioral Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2019) 		19
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2019) 		24
Actual Study Completion Date  ICMJE September 13, 2019
Actual Primary Completion Date September 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991676
Other Study ID Numbers  ICMJE DrexelUniversity
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Diane Dallal, Drexel University
Study Sponsor  ICMJE Drexel University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Diane H Dallal, B.A. Drexel University
PRS Account Drexel University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯