Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes

NCT ID: NCT02156752

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-08-29

Brief Summary

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This project is a randomized controlled trial to compare the efficacy of two interventions- one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)- and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. All participants will first participate in an initial 4-month standard behavioral weight loss program. Participants will be randomized into 1 of 3 groups and receive a 3-part workshop; the ACT workshop will teach ACT skills including acceptance and mindfulness techniques designed to promote behavior change and health behavior persistence consistent with one's core values. The SR program will focus on self-regulation, regular weighing, and modeling behavior on successful maintainers. The WLO group will receive a control workshop focused on cooking demonstrations and general nutrition topics.The primary outcome is weight loss at 24 months. The secondary outcome is change in psychological flexibility, a critical component of ACT interventions and a potential innovative mediating mechanism. Primary Hypothesis: At 24 months, the ACT group will show significantly greater weight loss as compared to the SR and WLO groups.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACT

Behavioral weight loss plus techniques from Acceptance and Commitment Therapy

Group Type EXPERIMENTAL

ACT

Intervention Type BEHAVIORAL

Treatment is based on Acceptance and Commitment Therapy

SR

Behavioral weight loss plus self-regulation techniques

Group Type ACTIVE_COMPARATOR

SR

Intervention Type BEHAVIORAL

Treatment is based on Self-Regulation theory.

WLO

Behavioral weight loss plus cooking tips and demonstrations

Group Type ACTIVE_COMPARATOR

WLO

Intervention Type BEHAVIORAL

Treatment is based on cooking tips and demonstrations.

Interventions

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ACT

Treatment is based on Acceptance and Commitment Therapy

Intervention Type BEHAVIORAL

SR

Treatment is based on Self-Regulation theory.

Intervention Type BEHAVIORAL

WLO

Treatment is based on cooking tips and demonstrations.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* BMI 27.5-40
* Age 30-65

Exclusion Criteria

* currently participating in a weight loss program
* pregnant or planning to become pregnant
* medical condition that would preclude physical activity
* terminal illness
* plans to relocate
* history of substance abuse or psychological problems that are judged by the investigators to be likely to interfere with study participation
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Lillis, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Lifespan/ The Miriam Hospital

Locations

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Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Lillis J, Dunsiger S, Thomas JG, Ross KM, Wing RR. Novel behavioral interventions to improve long-term weight loss: A randomized trial of acceptance and commitment therapy or self-regulation for weight loss maintenance. J Behav Med. 2021 Aug;44(4):527-540. doi: 10.1007/s10865-021-00215-z. Epub 2021 Mar 27.

Reference Type DERIVED
PMID: 33772702 (View on PubMed)

Lillis J, Thomas JG, Levin ME, Wing RR. Self-stigma and weight loss: The impact of fear of being stigmatized. J Health Psychol. 2020 Jun;25(7):922-930. doi: 10.1177/1359105317739101. Epub 2017 Nov 6.

Reference Type DERIVED
PMID: 29105491 (View on PubMed)

Other Identifiers

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5K23KDK097143

Identifier Type: -

Identifier Source: org_study_id

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