NCT02156752

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
Last Updated

September 18, 2019

Status Verified

August 1, 2019

Enrollment Period

3.5 years

First QC Date

May 22, 2014

Last Update Submit

September 16, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Weight

    24 months

Study Arms (3)

ACT

EXPERIMENTAL

Behavioral weight loss plus techniques from Acceptance and Commitment Therapy

Behavioral: ACT

SR

ACTIVE COMPARATOR

Behavioral weight loss plus self-regulation techniques

Behavioral: SR

WLO

ACTIVE COMPARATOR

Behavioral weight loss plus cooking tips and demonstrations

Behavioral: WLO

Interventions

ACTBEHAVIORAL

Treatment is based on Acceptance and Commitment Therapy

ACT
SRBEHAVIORAL

Treatment is based on Self-Regulation theory.

SR
WLOBEHAVIORAL

Treatment is based on cooking tips and demonstrations.

WLO

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 27.5-40
  • Age 30-65

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

  • 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.

    PMID: 33772702DERIVED

  • 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.

    PMID: 29105491DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jason Lillis, Ph.D.

    Lifespan/ The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2014

First Posted

June 5, 2014

Study Start

January 1, 2015

Primary Completion

July 1, 2018

Study Completion

August 29, 2019

Last Updated

September 18, 2019

Record last verified: 2019-08

Locations

US(1)