Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss
1 other identifier
interventional
480
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedOctober 23, 2023
October 1, 2023
4.6 years
January 21, 2020
October 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Weight Loss Maintenance
weight change from randomization to study end
30 months
Secondary Outcomes (2)
Waist Circumference
30 months
Objectively Measured Physical Activity Minutes Per Week
30 months
Study Arms (2)
Acceptance and Commitment Therapy (ACT)
EXPERIMENTALFocuses on addressing cognitive and emotional barriers to successful weight loss maintenance.
Self-Regulation (SR)
EXPERIMENTALFocuses on using self-monitoring and self-reinforcement techniques to improve weight loss maintenance.
Interventions
Teaches acceptance, mindfulness, and values-based skills
Teaches monitoring and reinforcement strategies designed to improve motivation and adherence to positive weight loss behavioral prescriptions.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903, United States
Related Publications (1)
Emerson JA, Schumacher LM, Bond DS, Thomas JG, Lillis J. Physical activity changes during an automated online weight loss program. J Behav Med. 2023 Aug;46(4):680-688. doi: 10.1007/s10865-022-00383-6. Epub 2023 Jan 5.
PMID: 36602619DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Lillis, Ph.D.
The Miriam Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2020
First Posted
February 5, 2020
Study Start
February 19, 2020
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
October 23, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After data analysis for the study is complete.
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.