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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Self-Regulation (SR)

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.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Weight Control and Diabetes Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance and Commitment Therapy (ACT); Focuses on addressing cognitive and emotional barriers to successful weight loss maintenance.	Behavioral: Acceptance and Commitment Therapy (ACT); Teaches acceptance, mindfulness, and values-based skills
Experimental: Self-Regulation (SR); Focuses on using self-monitoring and self-reinforcement techniques to improve weight loss maintenance.	Behavioral: Self-Regulation (SR); Teaches monitoring and reinforcement strategies designed to improve motivation and adherence to positive weight loss behavioral prescriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss Maintenance	weight change from randomization to study end	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist Circumference	change in waist circumference from randomization to study end	30 months
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	30 months

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Investigators: Principal Investigator: Jason Lillis, Ph.D., The Miriam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: R01DK120731 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No