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Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss

Primary Purpose

Overweight and Obesity

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy (ACT)
Self-Regulation (SR)
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English language fluent and literate at the 6th grade level
  • Body mass index (BMI) between 27.5 and 45 kg/m-squared
  • Able to walk 2 city blocks without stopping
  • Has reliable access to a computer with internet access

Exclusion Criteria:

  • Currently participating in another weight loss program
  • Currently taking weight loss medication
  • Has lost ≥5% of body weight in the 6 months prior to enrolling
  • Has been pregnant within the 6 months prior to enrolling
  • Plans to become pregnant within 18 months of enrolling
  • Has a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling
  • Has any medical condition that would affect the safety of participating in unsupervised physical activity
  • Has any condition that would result in inability to follow the study protocol, including terminal illness and untreated major psychiatric illness

Sites / Locations

  • Weight Control and Diabetes Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acceptance and Commitment Therapy (ACT)

Self-Regulation (SR)

Arm Description

Focuses on addressing cognitive and emotional barriers to successful weight loss maintenance.

Focuses on using self-monitoring and self-reinforcement techniques to improve weight loss maintenance.

Outcomes

Primary Outcome Measures

Weight Loss Maintenance
weight change from randomization to study end

Secondary Outcome Measures

Waist Circumference
change in waist circumference from randomization to study end
Objectively Measured Physical Activity Minutes Per Week
change in objectively measured physical activity from randomization to study end as measured by 7 days of wearing Actigraph accelerometer device

Full Information

First Posted
January 21, 2020
Last Updated
October 19, 2023
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04256850
Brief Title
Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss
Official Title
Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss: A Randomized Trial Examining the Efficacy of a Weight Loss Maintenance Intervention Based on Acceptance and Commitment Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This NIDDK funded R01 project is a randomized controlled clinical trial to compare the efficacy of an intervention based on Acceptance and Commitment Therapy (ACT) and a Self-Regulation (SR) intervention on weight loss maintenance over a 30-month period. All participants will first complete a well-validated online weight loss intervention (months 1-3 of the study). Participants who lose ≥4 kilograms of initial weight will then be randomly assigned to receive ACT or SR, with both conditions consisting of face-to-face, group-based intervention meetings and weekly email contact for 6 months.
Detailed Description
Obesity is a major public health problem, and although short-term weight loss is achievable, individuals often regain the majority of weight that was lost. Current approaches have adjusted behavioral prescriptions and lengthened treatment contact in an effort to address this problem, with modest effect. This NIDDK funded R01 project is a randomized controlled clinical trial to compare the efficacy of an intervention based on Acceptance and Commitment Therapy (ACT) and a Self-Regulation (SR) intervention on weight loss maintenance over a 30-month period. All participants will first complete a well-validated online weight loss intervention (months 1-3 of the study). Participants who lose ≥4 kilograms of initial weight will then be randomly assigned to receive ACT or SR, with both conditions consisting of face-to-face, group-based intervention meetings and weekly email contact for 6 months. The ACT intervention will target a novel theoretically derived intervention target, values-consistent behavior, which will help align weight loss goals with personal values and foster internal motivation to continue with weight control efforts. Assessments will be at baseline, post-weight loss/pre-randomization, and then 6, 12, 18, 24, and 30-month follow-up (months from randomization). This project will be conducted at the Weight Control and Diabetes Research Center (WCDRC). The WCDRC is part of the Centers for Behavioral and Preventive Medicine at The Miriam Hospital in Providence, Rhode Island, and the Department of Psychiatry and Human Behavior at the Alpert Medical School of Brown University. This study is significant because it addresses weight loss maintenance - a critical barrier to treating obesity - and results of the study could be used to improve long-term weight loss outcomes and associated health benefits for treatment seeing overweight and obese adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and Commitment Therapy (ACT)
Arm Type
Experimental
Arm Description
Focuses on addressing cognitive and emotional barriers to successful weight loss maintenance.
Arm Title
Self-Regulation (SR)
Arm Type
Experimental
Arm Description
Focuses on using self-monitoring and self-reinforcement techniques to improve weight loss maintenance.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy (ACT)
Intervention Description
Teaches acceptance, mindfulness, and values-based skills
Intervention Type
Behavioral
Intervention Name(s)
Self-Regulation (SR)
Intervention Description
Teaches monitoring and reinforcement strategies designed to improve motivation and adherence to positive weight loss behavioral prescriptions.
Primary Outcome Measure Information:
Title
Weight Loss Maintenance
Description
weight change from randomization to study end
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Waist Circumference
Description
change in waist circumference from randomization to study end
Time Frame
30 months
Title
Objectively Measured Physical Activity Minutes Per Week
Description
change in objectively measured physical activity from randomization to study end as measured by 7 days of wearing Actigraph accelerometer device
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English language fluent and literate at the 6th grade level Body mass index (BMI) between 27.5 and 45 kg/m-squared Able to walk 2 city blocks without stopping Has reliable access to a computer with internet access Exclusion Criteria: Currently participating in another weight loss program Currently taking weight loss medication Has lost ≥5% of body weight in the 6 months prior to enrolling Has been pregnant within the 6 months prior to enrolling Plans to become pregnant within 18 months of enrolling Has a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling Has any medical condition that would affect the safety of participating in unsupervised physical activity Has any condition that would result in inability to follow the study protocol, including terminal illness and untreated major psychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Lillis, Ph.D.
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data includes objective measurement of weight and height, physical activity, dietary intake, and self-report questionnaire data assessing values-consistent behavior, motivation, and use of weight control strategies. The final dataset will include self-reported demographic data. Research data from participants may be shared with the broader scientific community after publication. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that protecting the identities of participants is best achieved by enacting additional safeguards. We will therefore make data and documentation available only under a data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed; and (4) a commitment not to attempt to identify participants individually.
IPD Sharing Time Frame
After data analysis for the study is complete.

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Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss

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