NCT03738540

Brief Summary

Many behavioral weight loss interventions have been developed, but still have significant limitations in terms of achieving clinically significant, sustained weight loss. A recent study incorporating Acceptance and Commitment Therapy (ACT) in a randomized clinical trial resulted in participants who attained significantly greater 12-month weight loss in the ACT arm than those assigned to standard behavioral treatment, suggesting that ACT may have the potential to improve behavioral weight loss outcomes. The investigators have developed a novel telephone-delivered version of the ACT behavioral weight loss intervention, based on proven success using ACT telephone counseling intervention for smoking cessation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

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

Study Start

First participant enrolled

August 29, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

October 2, 2018

Last Update Submit

January 5, 2021

Conditions

Weight LossWeight, Body

Keywords

Weight lossNutritionExerciseDietTelephone coaching

Outcome Measures

Primary Outcomes (1)

  • 12-month weight loss

    Weight loss measured by BodyTrace scale. The BodyTrace medical body weight scale is a physical scale capable of assessing weight from 0.2 lbs to 397 lbs (0.1 kg to 180 kg) and securely sending data remotely through cellular (GSM) network.

    12 months post randomization

Secondary Outcomes (2)

  • 3-month weight loss

    3 months post randomization

  • 6-month weight loss

    6 months post randomization

Study Arms (2)

Experimental

EXPERIMENTAL

This is the experimental arm of the study. This includes 25 weekly then biweekly sessions of experimental therapy via telephone. Therapy description withheld to protect the integrity of the study.

Behavioral: TALK study group

Control

ACTIVE COMPARATOR

This is the control arm of the study. This includes This includes 25 weekly then biweekly sessions of control therapy via telephone.Therapy description withheld to protect the integrity of the study.

Behavioral: TALK control group

Interventions

TALK study groupBEHAVIORAL

Telephone Delivered Intervention

Experimental
TALK control groupBEHAVIORAL

Telephone Delivered Intervention

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or older,
  • overweight or obese (BMI ≥ 27),
  • wants to lose weight through healthy behavior change, beginning in the next 30 days,
  • interested in learning skills to lose weight,
  • willing to be randomly assigned to either condition,
  • resides in US,
  • has daily access to their own phone and email,
  • does not have a medical or psychiatric condition that would limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss, including meeting criteria for binge eating disorder,
  • not pregnant or planning to become pregnant in the next 12 months,
  • in the past 3 months changed the dosage of prescription medications that can cause a significant change in weight or appetite,
  • have lost more than 5% of their weight in the past 6 months,
  • willing and able to read in English,
  • not participating in or planning to participate in other weight loss programs, and
  • has not participated in our other ACT interventions. To increase follow-up data retention, eligibility criteria also include:
  • willing to complete the follow-up survey, and (16) provide email, phone, and mailing address.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • Bricker JB, Mull KE, Sullivan BM, Forman EM. Efficacy of telehealth acceptance and commitment therapy for weight loss: a pilot randomized clinical trial. Transl Behav Med. 2021 Aug 13;11(8):1527-1536. doi: 10.1093/tbm/ibab012.

    PMID: 33787926DERIVED

Related Links

MeSH Terms

Conditions

Weight LossBody WeightMotor Activity

Condition Hierarchy (Ancestors)

Body Weight ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jonathan Bricker, PhD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2018

First Posted

November 13, 2018

Study Start

August 29, 2018

Primary Completion

June 30, 2020

Study Completion

December 31, 2020

Last Updated

January 7, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)